coronavirus_clinical_trials.csv

,status,phase,sex,age,nct number,inclusion,exclusion,enrollment
0,"Active, not recruiting",Not Applicable,All,"18 Years and older   (Adult, Older Adult)",NCT04321421,death [ Time Frame: within 7 days ]death from any cause,"time to extubation [ Time Frame: within 7 days ]days since intubation
length of intensive care unit stay [ Time Frame: within 7 days ]days from entry to exit from ICU
time to CPAP weaning [ Time Frame: within 7 days ]days since CPAP initiation
viral load [ Time Frame: at days 1, 3 and 7 ]naso-pharyngeal swab, sputum and BAL
immune response [ Time Frame: at days 1, 3 and 7 ]neutralizing title length of intensive care unit stay [ Time Frame: within 7 days ]days from entry to exit from ICU
time to CPAP weaning [ Time Frame: within 7 days ]days since CPAP initiation
viral load [ Time Frame: at days 1, 3 and 7 ]naso-pharyngeal swab, sputum and BAL
immune response [ Time Frame: at days 1, 3 and 7 ]neutralizing title time to CPAP weaning [ Time Frame: within 7 days ]days since CPAP initiation
viral load [ Time Frame: at days 1, 3 and 7 ]naso-pharyngeal swab, sputum and BAL
immune response [ Time Frame: at days 1, 3 and 7 ]neutralizing title viral load [ Time Frame: at days 1, 3 and 7 ]naso-pharyngeal swab, sputum and BAL
immune response [ Time Frame: at days 1, 3 and 7 ]neutralizing title immune response [ Time Frame: at days 1, 3 and 7 ]neutralizing title",49
1,Not yet recruiting,"Phase 2
Phase 3",All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04291053,Mortality rate [ Time Frame: up to 28 days ]All cause mortality,"Clinical status assessed according to the official guideline [ Time Frame: up to 28 days ]1.mild type：no No symptoms, Imaging examination showed no signs of pneumonia; 2,moderate type: with fever or respiratory symptoms,Imaging examination showed signs of pneumonia, SpO2＞93% without oxygen inhalation ; severe type:Match any of the following：a. R≥30bpm；b.Pulse Oxygen Saturation(SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS
The differences in oxygen intake methods [ Time Frame: up to 28 days ]Pulse Oxygen Saturation(SpO2)＞93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）.
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]days
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]days
The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]days
Length of ICU stay (days) [ Time Frame: up to 28 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge The differences in oxygen intake methods [ Time Frame: up to 28 days ]Pulse Oxygen Saturation(SpO2)＞93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）.
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]days
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]days
The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]days
Length of ICU stay (days) [ Time Frame: up to 28 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]days
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]days
The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]days
Length of ICU stay (days) [ Time Frame: up to 28 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]days
The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]days
Length of ICU stay (days) [ Time Frame: up to 28 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]days
Length of ICU stay (days) [ Time Frame: up to 28 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge Length of hospital stay (days) [ Time Frame: up to 28 days ]days
Length of ICU stay (days) [ Time Frame: up to 28 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge Length of ICU stay (days) [ Time Frame: up to 28 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge",550
2,Recruiting,Not Applicable,All,"18 Years to 70 Years   (Adult, Older Adult)",NCT04324489,"Improved clinical status [ Time Frame: Day 14 ]Percent of subjects with improved clinical status
Return to room air [ Time Frame: Day 14 ]Percent of subjects return to room air Return to room air [ Time Frame: Day 14 ]Percent of subjects return to room air","SARS-CoV-2 RNA [ Time Frame: 28 days ]time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Discharge [ Time Frame: Days 14, 21, 28 ]Percent of patients discharge from hospital
Death [ Time Frame: Day 14, 21, 28 ]All-cause mortality rate Discharge [ Time Frame: Days 14, 21, 28 ]Percent of patients discharge from hospital
Death [ Time Frame: Day 14, 21, 28 ]All-cause mortality rate Death [ Time Frame: Day 14, 21, 28 ]All-cause mortality rate",4
3,Not yet recruiting,Phase 4,All,"18 Years to 65 Years   (Adult, Older Adult)",NCT04323228,"Change from baseline score of Nutrition risk screening-2002 (NRS-2002) at end of the trial [ Time Frame: up to 3 months ]Changes in scores of the NRS-2002 for patients with COVID-19 at the end of the study, from 0 to 7 scores, with those scores < 3 means no risk of malnutrition and >= 3 means malnutrition.
Change from baseline Serum ferritin level at end of the trial [ Time Frame: up to 3 months ]Change in serum ferritin at the end of the trial as ferritin is considered as a COVID-19 fatality predictor.
Change from baseline serum Interleukin-6 concentration at end of the trial [ Time Frame: up to 3 months ]Change in IL-6 at the end of the trial as it represent the cytokine storm and it is considered as a COVID-19 fatality predictor
Change from baseline serum C-reactive protein concentration at end of the trial [ Time Frame: up to 3 months ]Change in C-reactive protein in the serum at the end of the trial which reflect the acute phase
Change from baseline serum Tumor necrosis factor-α concentration at end of the trial [ Time Frame: up to 3 months ]Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm
Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial [ Time Frame: up to 3 months ]plasma MCP-1 represent severity of the cytokine storm Change from baseline Serum ferritin level at end of the trial [ Time Frame: up to 3 months ]Change in serum ferritin at the end of the trial as ferritin is considered as a COVID-19 fatality predictor.
Change from baseline serum Interleukin-6 concentration at end of the trial [ Time Frame: up to 3 months ]Change in IL-6 at the end of the trial as it represent the cytokine storm and it is considered as a COVID-19 fatality predictor
Change from baseline serum C-reactive protein concentration at end of the trial [ Time Frame: up to 3 months ]Change in C-reactive protein in the serum at the end of the trial which reflect the acute phase
Change from baseline serum Tumor necrosis factor-α concentration at end of the trial [ Time Frame: up to 3 months ]Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm
Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial [ Time Frame: up to 3 months ]plasma MCP-1 represent severity of the cytokine storm Change from baseline serum Interleukin-6 concentration at end of the trial [ Time Frame: up to 3 months ]Change in IL-6 at the end of the trial as it represent the cytokine storm and it is considered as a COVID-19 fatality predictor
Change from baseline serum C-reactive protein concentration at end of the trial [ Time Frame: up to 3 months ]Change in C-reactive protein in the serum at the end of the trial which reflect the acute phase
Change from baseline serum Tumor necrosis factor-α concentration at end of the trial [ Time Frame: up to 3 months ]Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm
Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial [ Time Frame: up to 3 months ]plasma MCP-1 represent severity of the cytokine storm Change from baseline serum C-reactive protein concentration at end of the trial [ Time Frame: up to 3 months ]Change in C-reactive protein in the serum at the end of the trial which reflect the acute phase
Change from baseline serum Tumor necrosis factor-α concentration at end of the trial [ Time Frame: up to 3 months ]Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm
Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial [ Time Frame: up to 3 months ]plasma MCP-1 represent severity of the cytokine storm Change from baseline serum Tumor necrosis factor-α concentration at end of the trial [ Time Frame: up to 3 months ]Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm
Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial [ Time Frame: up to 3 months ]plasma MCP-1 represent severity of the cytokine storm Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial [ Time Frame: up to 3 months ]plasma MCP-1 represent severity of the cytokine storm","Change from baseline Weight at end of the trial [ Time Frame: up to 3 months ]Body weight in Kg
Height [ Time Frame: up to 1 month ]stature in cm
Change from baseline BMI at end of the trial [ Time Frame: up to 3 months ]Claculation of BMI according to weight / square Height
Change from baseline mid arm circumference at end of the trial [ Time Frame: up to 3 months ]changes of MAC in cm
Change from baseline triceps skin-fold thickness at end of the trial [ Time Frame: up to 3 months ]changes of TSF in mm
Change from baseline MAMA at end of the trial [ Time Frame: Up to 3 months ]). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.
Change from baseline percentage of peripheral O2 saturation at end of the trial [ Time Frame: up to 3 months ]changes in the percentage of peripheral O2 saturation by an oximeter
Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]changes in the degree of body temperature by infrared thermometer
Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Height [ Time Frame: up to 1 month ]stature in cm
Change from baseline BMI at end of the trial [ Time Frame: up to 3 months ]Claculation of BMI according to weight / square Height
Change from baseline mid arm circumference at end of the trial [ Time Frame: up to 3 months ]changes of MAC in cm
Change from baseline triceps skin-fold thickness at end of the trial [ Time Frame: up to 3 months ]changes of TSF in mm
Change from baseline MAMA at end of the trial [ Time Frame: Up to 3 months ]). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.
Change from baseline percentage of peripheral O2 saturation at end of the trial [ Time Frame: up to 3 months ]changes in the percentage of peripheral O2 saturation by an oximeter
Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]changes in the degree of body temperature by infrared thermometer
Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline BMI at end of the trial [ Time Frame: up to 3 months ]Claculation of BMI according to weight / square Height
Change from baseline mid arm circumference at end of the trial [ Time Frame: up to 3 months ]changes of MAC in cm
Change from baseline triceps skin-fold thickness at end of the trial [ Time Frame: up to 3 months ]changes of TSF in mm
Change from baseline MAMA at end of the trial [ Time Frame: Up to 3 months ]). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.
Change from baseline percentage of peripheral O2 saturation at end of the trial [ Time Frame: up to 3 months ]changes in the percentage of peripheral O2 saturation by an oximeter
Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]changes in the degree of body temperature by infrared thermometer
Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline mid arm circumference at end of the trial [ Time Frame: up to 3 months ]changes of MAC in cm
Change from baseline triceps skin-fold thickness at end of the trial [ Time Frame: up to 3 months ]changes of TSF in mm
Change from baseline MAMA at end of the trial [ Time Frame: Up to 3 months ]). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.
Change from baseline percentage of peripheral O2 saturation at end of the trial [ Time Frame: up to 3 months ]changes in the percentage of peripheral O2 saturation by an oximeter
Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]changes in the degree of body temperature by infrared thermometer
Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline triceps skin-fold thickness at end of the trial [ Time Frame: up to 3 months ]changes of TSF in mm
Change from baseline MAMA at end of the trial [ Time Frame: Up to 3 months ]). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.
Change from baseline percentage of peripheral O2 saturation at end of the trial [ Time Frame: up to 3 months ]changes in the percentage of peripheral O2 saturation by an oximeter
Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]changes in the degree of body temperature by infrared thermometer
Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline MAMA at end of the trial [ Time Frame: Up to 3 months ]). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.
Change from baseline percentage of peripheral O2 saturation at end of the trial [ Time Frame: up to 3 months ]changes in the percentage of peripheral O2 saturation by an oximeter
Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]changes in the degree of body temperature by infrared thermometer
Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline percentage of peripheral O2 saturation at end of the trial [ Time Frame: up to 3 months ]changes in the percentage of peripheral O2 saturation by an oximeter
Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]changes in the degree of body temperature by infrared thermometer
Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]changes in the degree of body temperature by infrared thermometer
Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]change in the count from complete blood counts
Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]change in the rations calculated by division of the neutrophil count by the lymphocyte count",30
4,Withdrawn,Not Applicable,All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04287686,"Time course of body temperature (fever) [ Time Frame: 14 days ]Compare the time course of body temperature (fever) between two groups over time.
Viral load over time [ Time Frame: 14 days ]Compare viral load between two groups over time. Viral load over time [ Time Frame: 14 days ]Compare viral load between two groups over time.","P/F ratio over time [ Time Frame: 14 days ]PaO2/FiO2 ratio
Sequential organ failure assessment score(SOFA score) over time [ Time Frame: 14 days ]SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.
Pulmonary Severity Index (PSI) [ Time Frame: 14 days ]
Image examination of chest over time [ Time Frame: 14 days ]Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.
Proportion of subjects who progressed to critical illness or death [ Time Frame: 14 days ]
Time from first dose to conversion to normal or mild pneumonia [ Time Frame: 14 days ]
T-lymphocyte counts over time [ Time Frame: 14 days ]
C-reactive protein levels over time [ Time Frame: 14 days ]
Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Sequential organ failure assessment score(SOFA score) over time [ Time Frame: 14 days ]SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.
Pulmonary Severity Index (PSI) [ Time Frame: 14 days ]
Image examination of chest over time [ Time Frame: 14 days ]Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.
Proportion of subjects who progressed to critical illness or death [ Time Frame: 14 days ]
Time from first dose to conversion to normal or mild pneumonia [ Time Frame: 14 days ]
T-lymphocyte counts over time [ Time Frame: 14 days ]
C-reactive protein levels over time [ Time Frame: 14 days ]
Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Pulmonary Severity Index (PSI) [ Time Frame: 14 days ]
Image examination of chest over time [ Time Frame: 14 days ]Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.
Proportion of subjects who progressed to critical illness or death [ Time Frame: 14 days ]
Time from first dose to conversion to normal or mild pneumonia [ Time Frame: 14 days ]
T-lymphocyte counts over time [ Time Frame: 14 days ]
C-reactive protein levels over time [ Time Frame: 14 days ]
Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Image examination of chest over time [ Time Frame: 14 days ]Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.
Proportion of subjects who progressed to critical illness or death [ Time Frame: 14 days ]
Time from first dose to conversion to normal or mild pneumonia [ Time Frame: 14 days ]
T-lymphocyte counts over time [ Time Frame: 14 days ]
C-reactive protein levels over time [ Time Frame: 14 days ]
Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Proportion of subjects who progressed to critical illness or death [ Time Frame: 14 days ]
Time from first dose to conversion to normal or mild pneumonia [ Time Frame: 14 days ]
T-lymphocyte counts over time [ Time Frame: 14 days ]
C-reactive protein levels over time [ Time Frame: 14 days ]
Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Time from first dose to conversion to normal or mild pneumonia [ Time Frame: 14 days ]
T-lymphocyte counts over time [ Time Frame: 14 days ]
C-reactive protein levels over time [ Time Frame: 14 days ]
Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] T-lymphocyte counts over time [ Time Frame: 14 days ]
C-reactive protein levels over time [ Time Frame: 14 days ]
Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] C-reactive protein levels over time [ Time Frame: 14 days ]
Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Angiotensin II (Ang II) changes over time [ Time Frame: 14 days ]
Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Angiotensin 1-7 (Ang 1-7) changes over time [ Time Frame: 14 days ]
Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Angiotensin 1-5 (Ang 1-5) changes over time [ Time Frame: 14 days ]
Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Renin changes over time [ Time Frame: 14 days ]
Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Aldosterone changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Angiotensin-converting enzyme (ACE) changes over time [ Time Frame: 14 days ]
Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Angiotensin-converting enzyme 2 (ACE2) changes over time [ Time Frame: 14 days ]
Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Interleukin 6 (IL-6) changes over time [ Time Frame: 14 days ]
Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Interleukin 8 (IL-8) changes over time [ Time Frame: 14 days ]
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time [ Time Frame: 14 days ]
Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Plasminogen activator inhibitor type-1 (PAI-1) changes over time [ Time Frame: 14 days ]
Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Von willebrand factor (vWF) changes over time [ Time Frame: 14 days ]
Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Tumor necrosis factor-α (TNF-α) changes over time [ Time Frame: 14 days ]
Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Soluble receptor for advanced glycation end products (sRAGE) changes over time [ Time Frame: 14 days ]
Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Surfactant protein-D (SP-D) changes over time [ Time Frame: 14 days ]
Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Angiopoietin-2 changes over time [ Time Frame: 14 days ]
Frequency of adverse events and severe adverse events [ Time Frame: 14 days ] Frequency of adverse events and severe adverse events [ Time Frame: 14 days ]",0
5,Not yet recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04325633,Mortality all causes at day30 [ Time Frame: at day30 ],"Number of days alive free of mechanical ventilation [ Time Frame: during 30 days after randomization ]
Number of days alive outside [ Time Frame: during 30 days after randomization ]
Number of days alive outside hospital [ Time Frame: during 30 days after randomization ]
Maximal changes in Sofa score [ Time Frame: in the first 7 days after randomization ]
Time to negativation of virus titer in the nasopharyngeal aspirate (NPA) [ Time Frame: during 90 days after randomization ] Number of days alive outside [ Time Frame: during 30 days after randomization ]
Number of days alive outside hospital [ Time Frame: during 30 days after randomization ]
Maximal changes in Sofa score [ Time Frame: in the first 7 days after randomization ]
Time to negativation of virus titer in the nasopharyngeal aspirate (NPA) [ Time Frame: during 90 days after randomization ] Number of days alive outside hospital [ Time Frame: during 30 days after randomization ]
Maximal changes in Sofa score [ Time Frame: in the first 7 days after randomization ]
Time to negativation of virus titer in the nasopharyngeal aspirate (NPA) [ Time Frame: during 90 days after randomization ] Maximal changes in Sofa score [ Time Frame: in the first 7 days after randomization ]
Time to negativation of virus titer in the nasopharyngeal aspirate (NPA) [ Time Frame: during 90 days after randomization ] Time to negativation of virus titer in the nasopharyngeal aspirate (NPA) [ Time Frame: during 90 days after randomization ]",584
6,Not yet recruiting,Phase 3,All,"up to 85 Years   (Child, Adult, Older Adult)",NCT04323332,Length of hospital stay (days) [ Time Frame: First treatment date up to 3 months ],"Duration (days) of supplemental oxygenation [ Time Frame: First treatment date up to 3 months ]
CT imaging changes [ Time Frame: First treatment date up to 3 months ]
Mortality rate [ Time Frame: First treatment date up to 3 months ]
Time to Clinical Improvement (TTCI) [ Time Frame: First treatment date up to 3 months ]
The pneumonia severity index scores [ Time Frame: First treatment date up to 3 months ]The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.
Time to COVID-19 nucleic acid testing negativity in throat swab [ Time Frame: First treatment date up to 3 months ]
Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] CT imaging changes [ Time Frame: First treatment date up to 3 months ]
Mortality rate [ Time Frame: First treatment date up to 3 months ]
Time to Clinical Improvement (TTCI) [ Time Frame: First treatment date up to 3 months ]
The pneumonia severity index scores [ Time Frame: First treatment date up to 3 months ]The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.
Time to COVID-19 nucleic acid testing negativity in throat swab [ Time Frame: First treatment date up to 3 months ]
Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Mortality rate [ Time Frame: First treatment date up to 3 months ]
Time to Clinical Improvement (TTCI) [ Time Frame: First treatment date up to 3 months ]
The pneumonia severity index scores [ Time Frame: First treatment date up to 3 months ]The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.
Time to COVID-19 nucleic acid testing negativity in throat swab [ Time Frame: First treatment date up to 3 months ]
Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Time to Clinical Improvement (TTCI) [ Time Frame: First treatment date up to 3 months ]
The pneumonia severity index scores [ Time Frame: First treatment date up to 3 months ]The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.
Time to COVID-19 nucleic acid testing negativity in throat swab [ Time Frame: First treatment date up to 3 months ]
Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] The pneumonia severity index scores [ Time Frame: First treatment date up to 3 months ]The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.
Time to COVID-19 nucleic acid testing negativity in throat swab [ Time Frame: First treatment date up to 3 months ]
Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Time to COVID-19 nucleic acid testing negativity in throat swab [ Time Frame: First treatment date up to 3 months ]
Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Blood immune cell count [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Serum inflammatory markers [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Serum inflammatory markers [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Erythrocyte sedimentation rate [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in erythrocyte sedimentation rate from baseline.
Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Platelet and D-dimer changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in platelets and D-dimers from baseline.
Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Creatinine changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum creatinine from baseline.
Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Muscle enzymes changes [ Time Frame: Baseline, 7 and/ or 14 days ]Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Usage of antibiotics [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of antibiotics；the categories of the antibiotics
Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Usage of glucocorticoids [ Time Frame: First treatment date up to 3 months ]Dosing time and amounts of glucocorticoids
Frequency of adverse events [ Time Frame: First treatment date up to 3 months ] Frequency of adverse events [ Time Frame: First treatment date up to 3 months ]",50
7,Recruiting,,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04306497,"Routine treatment：
① support treatment:maintain water and electrolyte balance .
②oxygen therapy: give nasal catheters to inhale oxygen.
③ basic treatment of traditional Chinese and western medicine: antiviral drugs and proprietary Chinese medicines with similar composition or function to the observed scheme of differentiation and treatment of traditional Chinese medicine are not included in the scope of such drugs. Antiviral drugs ：Clinicians can judge according to the patient's condition according to the latest version of the diagnosis and treatment plan for COvID-19 issued by the General Office of the National Health Commission / the Office of the State Administration of traditional Chinese Medicine (currently the latest version is the sixth trial edition). Select any of the recommended antiviral drugs(for example:IFN-α、lopinavir-ritonavir、Ribavirin、Chloroquine Phosphate、Arbidol)or a combination of two antiviral drugs.","The relief / disappearance rate of main symptoms [ Time Frame: 9day ]disappearance of fever, cough and shortness of breath/ the rate of complete relief /.
Chest CT absorption [ Time Frame: 9day ]with reference to the ""pneumonia chest X-ray absorption Evaluation scale"" developed by Renyi Yin et al, the final absorption judgment will be used to evaluate the chest CT absorption of patients with pneumonia, which is divided into four levels according to the degree of absorption: complete absorption, majority absorption, partial absorption and no absorption. Chest CT absorption [ Time Frame: 9day ]with reference to the ""pneumonia chest X-ray absorption Evaluation scale"" developed by Renyi Yin et al, the final absorption judgment will be used to evaluate the chest CT absorption of patients with pneumonia, which is divided into four levels according to the degree of absorption: complete absorption, majority absorption, partial absorption and no absorption.",340
8,Recruiting,Phase 2,All,"Child, Adult, Older Adult",NCT04317092,One-month mortality rate [ Time Frame: up to 1 month ]1-month mortality is defined as the ratio of patients who will alive after 1month from study start out of those registered at baseline,"Interleukin-6 level [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]IL-6 levels will be assessed using commercial ELISA method.
Lymphocyte count [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]Lymphocyte count assessed by routinely used determination of blood count
CRP (C-reactive protein) level [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]CRP is assessed by routinely used determination of CRP
PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]calculated from arterial blood gas analyses (values from 300 to 100)
Change of the SOFA (Sequential Organ Failure Assessment) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 [ Time Frame: during treatment and up to 30 days after the last treatment dose ]graded according to CTCAE citeria (v5.0)
Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]Thoracic CT scan or Chest XR
Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]Days of hospitalization
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Lymphocyte count [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]Lymphocyte count assessed by routinely used determination of blood count
CRP (C-reactive protein) level [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]CRP is assessed by routinely used determination of CRP
PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]calculated from arterial blood gas analyses (values from 300 to 100)
Change of the SOFA (Sequential Organ Failure Assessment) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 [ Time Frame: during treatment and up to 30 days after the last treatment dose ]graded according to CTCAE citeria (v5.0)
Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]Thoracic CT scan or Chest XR
Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]Days of hospitalization
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days CRP (C-reactive protein) level [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]CRP is assessed by routinely used determination of CRP
PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]calculated from arterial blood gas analyses (values from 300 to 100)
Change of the SOFA (Sequential Organ Failure Assessment) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 [ Time Frame: during treatment and up to 30 days after the last treatment dose ]graded according to CTCAE citeria (v5.0)
Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]Thoracic CT scan or Chest XR
Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]Days of hospitalization
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]calculated from arterial blood gas analyses (values from 300 to 100)
Change of the SOFA (Sequential Organ Failure Assessment) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 [ Time Frame: during treatment and up to 30 days after the last treatment dose ]graded according to CTCAE citeria (v5.0)
Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]Thoracic CT scan or Chest XR
Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]Days of hospitalization
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Change of the SOFA (Sequential Organ Failure Assessment) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 [ Time Frame: during treatment and up to 30 days after the last treatment dose ]graded according to CTCAE citeria (v5.0)
Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]Thoracic CT scan or Chest XR
Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]Days of hospitalization
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 [ Time Frame: during treatment and up to 30 days after the last treatment dose ]graded according to CTCAE citeria (v5.0)
Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]Thoracic CT scan or Chest XR
Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]Days of hospitalization
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]Thoracic CT scan or Chest XR
Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]Days of hospitalization
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]Days of hospitalization
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to definitive extubation calculated from intubation (any time occurred) to extubation in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from non-invasive mechanical ventilation calculated in days
Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days Remission of respiratory symptoms [ Time Frame: up to 1 month ]time to independence from oxygen therapy in days",330
9,Recruiting,"Phase 1
Phase 2",All,"18 Years and older   (Adult, Older Adult)",NCT04324996,"Clinical response [ Time Frame: Up to 28 days ]the efficacy of NKG2D-ACE2 CAR-NK cells in treating severe and critical 2019 new coronavirus (COVID-19) pneumonia
Side effects in the treatment group [ Time Frame: Up to 28 days ]the safety and tolerability of NKG2D-ACE2 CAR-NK cells in patients with severe and critical 2019 new coronavirus (COVID-19) pneumonia Side effects in the treatment group [ Time Frame: Up to 28 days ]the safety and tolerability of NKG2D-ACE2 CAR-NK cells in patients with severe and critical 2019 new coronavirus (COVID-19) pneumonia","Sign written informed consent; Age ≥18 years; Conforms to the NCP Critical and Critical Diagnostic Standards, namely ""Pneumonitis Diagnosis and Treatment Scheme for New Coronavirus Infection (Trial Version 6)"". Comprehensive judgment based on epidemiological history, clinical manifestations and etiological examination; The course of disease is within 14 days after the onset of illness; Willing to collect nasopharyngeal or oropharyngeal swabs before administration.",90
10,Recruiting,,All,"18 Years to 90 Years   (Adult, Older Adult)",NCT04275947,"Accuracy of nCapp COVID-19 risk diagnostic model [ Time Frame: 1 day ]Sensitivity, specificity and area under the ROC curve of nCapp model",High risk of COVID-19 RT-PCR test result of SAR2-CoV-19,450
11,Recruiting,"Phase 2
Phase 3",All,"18 Years and older   (Adult, Older Adult)",NCT04315298,Kevzara® REGN88 SAR153191,Kevzara® REGN88 SAR153191,400
12,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04304313,"Rate of disease remission [ Time Frame: 14 days ]
fever,cough and other symptoms relieved with improved lung CT;
SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation.

Rate of entering the critical stage [ Time Frame: 14 days ]Comply with any of the followings:

Respiratory failure occurs and requires mechanical ventilation;
Shock;
Patients combined with other organ failure need ICU monitoring and treatment.

Time of entering the critical stage [ Time Frame: 14 days ]Comply with any of the followings:

Respiratory failure occurs and requires mechanical ventilation;
Shock;
Patients combined with other organ failure need ICU monitoring and treatment. fever,cough and other symptoms relieved with improved lung CT; SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation. Rate of entering the critical stage [ Time Frame: 14 days ]Comply with any of the followings:

Respiratory failure occurs and requires mechanical ventilation;
Shock;
Patients combined with other organ failure need ICU monitoring and treatment.

Time of entering the critical stage [ Time Frame: 14 days ]Comply with any of the followings:

Respiratory failure occurs and requires mechanical ventilation;
Shock;
Patients combined with other organ failure need ICU monitoring and treatment. Respiratory failure occurs and requires mechanical ventilation; Shock; Patients combined with other organ failure need ICU monitoring and treatment. Time of entering the critical stage [ Time Frame: 14 days ]Comply with any of the followings:

Respiratory failure occurs and requires mechanical ventilation;
Shock;
Patients combined with other organ failure need ICU monitoring and treatment. Respiratory failure occurs and requires mechanical ventilation; Shock; Patients combined with other organ failure need ICU monitoring and treatment.","fever,cough and other symptoms relieved with improved lung CT; SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation.",10
13,Not yet recruiting,,All,"Child, Adult, Older Adult",NCT04318418,Severe COVID-19 [ Time Frame: 1 month ]Severity pneumonia or acute respiratory distress syndrome by COVID-19,Death [ Time Frame: 1 month ]Death by COVID-19,5000
14,Completed,,All,"18 Years and older   (Adult, Older Adult)",NCT04285801,28 day mortality [ Time Frame: 28 days ]survival or death at 28 days,"vasopressor days [ Time Frame: 28 days ]days on vasopressor
days on mechanical ventilation [ Time Frame: 28 days ]days on mechanical ventilation during ICU stay
sequential organ function assessment score [ Time Frame: daily for first 5 days ]daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function
ECMO use [ Time Frame: 28 days ]Percentage of patients requiring ECMO during ICU stay.
percentage nitric oxide use [ Time Frame: 28 days ]percentage of patients requiring nitric oxide during ICU stay.
percentage free from oxygen supplement [ Time Frame: 28 days ]percentage not requiring oxygen therapy days on mechanical ventilation [ Time Frame: 28 days ]days on mechanical ventilation during ICU stay
sequential organ function assessment score [ Time Frame: daily for first 5 days ]daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function
ECMO use [ Time Frame: 28 days ]Percentage of patients requiring ECMO during ICU stay.
percentage nitric oxide use [ Time Frame: 28 days ]percentage of patients requiring nitric oxide during ICU stay.
percentage free from oxygen supplement [ Time Frame: 28 days ]percentage not requiring oxygen therapy sequential organ function assessment score [ Time Frame: daily for first 5 days ]daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function
ECMO use [ Time Frame: 28 days ]Percentage of patients requiring ECMO during ICU stay.
percentage nitric oxide use [ Time Frame: 28 days ]percentage of patients requiring nitric oxide during ICU stay.
percentage free from oxygen supplement [ Time Frame: 28 days ]percentage not requiring oxygen therapy ECMO use [ Time Frame: 28 days ]Percentage of patients requiring ECMO during ICU stay.
percentage nitric oxide use [ Time Frame: 28 days ]percentage of patients requiring nitric oxide during ICU stay.
percentage free from oxygen supplement [ Time Frame: 28 days ]percentage not requiring oxygen therapy percentage nitric oxide use [ Time Frame: 28 days ]percentage of patients requiring nitric oxide during ICU stay.
percentage free from oxygen supplement [ Time Frame: 28 days ]percentage not requiring oxygen therapy percentage free from oxygen supplement [ Time Frame: 28 days ]percentage not requiring oxygen therapy",8
15,Recruiting,Phase 1,All,"6 Months to 80 Years   (Child, Adult, Older Adult)",NCT04299724,"Based on the genomic sequence of the new coronavirus SARS-CoV-2, select conserved and critical structural and protease protein domains to engineer lentiviral minigenes to express SARS-CoV-2 antigens. The Covid-19/aAPC vaccine is prepared by applying lentivirus modification including immune modulatory genes and the viral minigenes, to the artificial antigen presenting cells (aAPCs). The Covid-19/aAPCs are then inactivated for proliferation and extensively safety tested. The subjects receive a total of 5x10^ 6 cells each time by subcutaneous injection at 0, 14 and 28 days. The subjects are followed-up with peripheral blood tests at 0, 14, 21, 28 and 60 days until the end of the test.","Frequency of vaccine events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of vaccine events such as fever, rash, and abnormal heart function.
Frequency of serious vaccine events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of serious vaccine events
Proportion of subjects with positive T cell response [ Time Frame: 14 and 28 days after randomization ] Frequency of serious vaccine events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of serious vaccine events
Proportion of subjects with positive T cell response [ Time Frame: 14 and 28 days after randomization ] Proportion of subjects with positive T cell response [ Time Frame: 14 and 28 days after randomization ]",100
16,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04304053,Effectiveness of chemoprophylaxis assessed by incidence of secondary COVID-19 cases [ Time Frame: Up to 14 days after start of treatment ]Incidence of secondary cases among contacts of a case and contacts of contacts,"The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at days 3 [ Time Frame: 3 days after start of treatment ]
The mortality rate of subjects at weeks 2 [ Time Frame: Up to 14 days after start of treatment ]
Proportion of participants that drop out of study [ Time Frame: Up to 14 days after start of treatment ]
Proportion of participants that show non-compliance with study drug [ Time Frame: Up to 14 days after start of treatment ] The mortality rate of subjects at weeks 2 [ Time Frame: Up to 14 days after start of treatment ]
Proportion of participants that drop out of study [ Time Frame: Up to 14 days after start of treatment ]
Proportion of participants that show non-compliance with study drug [ Time Frame: Up to 14 days after start of treatment ] Proportion of participants that drop out of study [ Time Frame: Up to 14 days after start of treatment ]
Proportion of participants that show non-compliance with study drug [ Time Frame: Up to 14 days after start of treatment ] Proportion of participants that show non-compliance with study drug [ Time Frame: Up to 14 days after start of treatment ]",3040
17,Recruiting,,All,"25 Years to 65 Years   (Adult, Older Adult)",NCT04319315,"Other: survey
online survey",Number of physicians affected by social media measured by online survey designed to measure the influence of social media on medical practice [ Time Frame: one month ]the survey will be send and received online and data will be analysed,400
18,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04321993,"Clinical status of subject at day 15 (on a 7 point ordinal scale). [ Time Frame: Up to 15 days ]
Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities;
Hospitalized, not requiring supplemental oxygen;
Hospitalized, requiring supplemental oxygen;
Hospitalized, on non-invasive ventilation or high flow oxygen devices;
Hospitalized, on invasive mechanical ventilation or ECMO;
Death. Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.","Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.",1000
19,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04313023,Prevention of COVID-19 [ Time Frame: 14 days ]Difference in the incidence of infection with SARS-CoV-2,"1. Subjects must have documented exposure to COVID-19 and have a documented negative test for the virus within 72 hours of the administration of study drug 2. Subjects must be free of clinical symptoms (fever, cough, shortness of breath) of a potential COVID-19 infection 3. Subjects must be under quarantine in a controlled facility or hospital (home quarantine is not sufficient) 4. Spirometry (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) ≥70% of predicted value 5. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control. 6. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1. 7. If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control. 8. Ability to understand and give informed consent.",200
20,Recruiting,Phase 2,All,"16 Years to 99 Years   (Child, Adult, Older Adult)",NCT04307693,"Viral load [ Time Frame: hospital day 3, 5, 7, 10, 14, 18 ]Area under the curve (AUC) of Ct value or viral copies number per mL","Viral load change [ Time Frame: hospital day 3, 5, 7, 10, 14, 18 ]Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)
Time to clinical improvement (TTCI) [ Time Frame: up to 28 days ]Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours
Percentage of progression to supplemental oxygen requirement by day 7 [ Time Frame: hospital day 7 ]Percentage of progression to supplemental oxygen requirement by day 7
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7 [ Time Frame: hospital day 7 ]Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission [ Time Frame: up to 28 days ]Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 [ Time Frame: hospital day 7 ]Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
adverse effects [ Time Frame: up to 28 days ]Safety and tolerability, as assessed by adverse effects
Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]Concentration of Lopinavir/ritonavir and hydroxychloroquine Time to clinical improvement (TTCI) [ Time Frame: up to 28 days ]Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours
Percentage of progression to supplemental oxygen requirement by day 7 [ Time Frame: hospital day 7 ]Percentage of progression to supplemental oxygen requirement by day 7
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7 [ Time Frame: hospital day 7 ]Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission [ Time Frame: up to 28 days ]Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 [ Time Frame: hospital day 7 ]Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
adverse effects [ Time Frame: up to 28 days ]Safety and tolerability, as assessed by adverse effects
Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]Concentration of Lopinavir/ritonavir and hydroxychloroquine Percentage of progression to supplemental oxygen requirement by day 7 [ Time Frame: hospital day 7 ]Percentage of progression to supplemental oxygen requirement by day 7
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7 [ Time Frame: hospital day 7 ]Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission [ Time Frame: up to 28 days ]Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 [ Time Frame: hospital day 7 ]Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
adverse effects [ Time Frame: up to 28 days ]Safety and tolerability, as assessed by adverse effects
Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]Concentration of Lopinavir/ritonavir and hydroxychloroquine Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7 [ Time Frame: hospital day 7 ]Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission [ Time Frame: up to 28 days ]Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 [ Time Frame: hospital day 7 ]Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
adverse effects [ Time Frame: up to 28 days ]Safety and tolerability, as assessed by adverse effects
Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]Concentration of Lopinavir/ritonavir and hydroxychloroquine Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission [ Time Frame: up to 28 days ]Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 [ Time Frame: hospital day 7 ]Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
adverse effects [ Time Frame: up to 28 days ]Safety and tolerability, as assessed by adverse effects
Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]Concentration of Lopinavir/ritonavir and hydroxychloroquine Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 [ Time Frame: hospital day 7 ]Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
adverse effects [ Time Frame: up to 28 days ]Safety and tolerability, as assessed by adverse effects
Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]Concentration of Lopinavir/ritonavir and hydroxychloroquine adverse effects [ Time Frame: up to 28 days ]Safety and tolerability, as assessed by adverse effects
Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]Concentration of Lopinavir/ritonavir and hydroxychloroquine Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]Concentration of Lopinavir/ritonavir and hydroxychloroquine",150
21,Not yet recruiting,Early Phase 1,All,"18 Years and older   (Adult, Older Adult)",NCT04323631,"Adult patients (>18 years) Confirmed COVID-19 infection by real-time PCR from a respiratory or other body sample within 48 hours of testing. Mild to moderate infection or asymptomatic patients with comorbidities: Symptomatic patients with fever >37.9ºC or cough or dyspnea or chest pain, not fulfilling severity exclusion criteria. We will include patients regardless of time since symptom onset. In addition, we will include asymptomatic patients with comorbidities including cardiac, pulmonary, diabetes, chronic renal failure or liver disease (definitions in Appendix 1) hospitalized for observation. Informed consent from patient or legal representative","Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. Unable to take oral medication Known allergy to HCQ or chloroquine Prolonged QT, defined as QTc ≥450 milliseconds for men and as QTc ≥470 for women Severely reduced LV function (Ejection fraction<30%) Retinopathy Pregnancy or breast feeding Concomitant treatment with azithromycin, flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, pimozide. Chronic chloroquine/ HCQ treatment (within 1 month) Need for hemodialysis Participating in another RCT for treatment of COVID-19 Patients who meet eligibility criteria will be randomized in a 1:1 ration. Randomization will be done using a computer-generated list of random numbers allocated centrally through a web site, stratified by hospital. The random sequence will include random permuted blocks of 4 The intervention group will receive oral hydroxychloroquine. In the first day 400 mg twice daily, followed by 200mg twice daily on days 2-10 (continued after discharge if discharged before day 10).",1116
22,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04292899,"Proportion of Participants With Normalization of Fever and Oxygen Saturation Through Day 14 [ Time Frame: First dose date up to 14 days ]This is a composite outcome measure. Criteria for fever normalization: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 24 hours and criteria for oxygen normalization: peripheral capillary oxygen saturation (Sp02) > 94% sustained for at least 24 hours.",Proportion of Participants With Treatment Emergent Adverse Events Leading to Study Drug Discontinuation [ Time Frame: First dose date up to 10 days ],400
23,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04312997,Severity of COVID-19 [ Time Frame: 14 days ]Ordinal Scale for Clinical Improvement (score 1-8),All cause mortality [ Time Frame: 28 days ]Death,100
24,Recruiting,Phase 1,All,"18 Years and older   (Adult, Older Adult)",NCT04313322,"Clinical outcome [ Time Frame: 3 weeks ]Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
CT Scan [ Time Frame: 3 weeks ]Side effects measured by Chest Readiograph
RT-PCR results [ Time Frame: 3 weeks ]Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative CT Scan [ Time Frame: 3 weeks ]Side effects measured by Chest Readiograph
RT-PCR results [ Time Frame: 3 weeks ]Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative RT-PCR results [ Time Frame: 3 weeks ]Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative","RT-PCR results [ Time Frame: 8 weeks ]Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative",5
25,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04292730,Proportion of Participants Discharged by Day 14 [ Time Frame: First dose date or randomization date up to 14 days ],Proportion of Participants With Treatment Emergent Adverse Events Leading to Study Drug Discontinuation [ Time Frame: First dose date up to 10 days ],600
26,Enrolling by invitation,Phase 4,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04308317,Survival rate [ Time Frame: 12 weeks ]Death event,body temperature [ Time Frame: 2 weeks ]inflammatory indicator,60
27,Recruiting,"Phase 1
Phase 2",All,"6 Months to 80 Years   (Child, Adult, Older Adult)",NCT04276896,"Based on the genomic sequence of the new coronavirus Covid-19, select conserved and critical structural and protease protein domains to engineer lentiviral SMENP minigenes to express Covid-19 antigens. LV-SMENP-DC vaccine is made by modifying DC with lentivirus vectors expressing Covid-19 minigene SMENP and immune modulatory genes. CTLs will be activated by LV-DC presenting Covid-19 specific antigens. LV-DC vaccine and antigen-specific CTLs are prepared in 7~21 days. Subject will receive total 5x10^6 cells of LV-DC vaccine and 1x10^8 antigen-specific CTLs via sub-cutaneous injection and IV infusion, respectively. Patients are followed weekly for one month after the infusion, monthly for 3 months, and then every 3 months until the trial ends.","Clinical improvement based on the 7-point scale [ Time Frame: 28 days after randomization ]A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Lower Murray lung injury score [ Time Frame: 7 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition. Lower Murray lung injury score [ Time Frame: 7 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.",100
28,Enrolling by invitation,,All,"18 Years and older   (Adult, Older Adult)",NCT04312464,"The myocardial injury incidence [ Time Frame: 75 days ]The myocardial injury incidence of COVID-19 patients
The risk factors analysis for the death [ Time Frame: 75 days ]The risk factors analysis for the death of COVID-19 patients The risk factors analysis for the death [ Time Frame: 75 days ]The risk factors analysis for the death of COVID-19 patients","Clinical characteristics [ Time Frame: 75 days ]The clinical characteristics description of COVID-19 patients
Clinical course [ Time Frame: 75 days ]The clinical course description of COVID-19 patients
Cardiovascular comorbidity [ Time Frame: 75 days ]The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients
Analysis of causes of death [ Time Frame: 75 days ]Analysis of causes of death in COVID-19 patients Clinical course [ Time Frame: 75 days ]The clinical course description of COVID-19 patients
Cardiovascular comorbidity [ Time Frame: 75 days ]The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients
Analysis of causes of death [ Time Frame: 75 days ]Analysis of causes of death in COVID-19 patients Cardiovascular comorbidity [ Time Frame: 75 days ]The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients
Analysis of causes of death [ Time Frame: 75 days ]Analysis of causes of death in COVID-19 patients Analysis of causes of death [ Time Frame: 75 days ]Analysis of causes of death in COVID-19 patients",500
29,Recruiting,Not Applicable,All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04305106,The time from randomization to clinical improvement [ Time Frame: No more than 28 days ]The time from randomization to an improvement of two points on a seven-category ordinal scale or live discharge from the hospital,"Age: 18-80 years old, male and female; Covid-19 confirmed cases; Comply with any of the following:


Dyspnea, RR ≥ 30 times / min;


In resting state, transcutaneous oxygen saturation ≤ 93%;

Oxygenation index (PaO2 / FiO2) < 300MMHG; Dyspnea, RR ≥ 30 times / min;


In resting state, transcutaneous oxygen saturation ≤ 93%;

Oxygenation index (PaO2 / FiO2) < 300MMHG; In resting state, transcutaneous oxygen saturation ≤ 93%;

Oxygenation index (PaO2 / FiO2) < 300MMHG; Oxygenation index (PaO2 / FiO2) < 300MMHG; Pulmonary imaging showed diffuse exudative lesions.",140
30,Not yet recruiting,Phase 1,All,"18 Years and older   (Adult, Older Adult)",NCT04315987,Disappear time of ground-glass shadow in the lungs [ Time Frame: 28 days ]Evaluation of Pneumonia change. Kaplan-meier method will be used to calculate the median glassy shadow time in all subjects,"Rate of mortality within 28-days [ Time Frame: 28 days ]Evaluation of Pneumonia change
Change of Clinical symptoms including duration of fever and respiratory [ Time Frame: At Baseline , Day 3, Day 7, Day 10, Day 14, Day 21, Day 28 ]Evaluation of Pneumonia change
Time of nucleic acid turning negative [ Time Frame: 28 days ]Marker for 2019-nCoV
CD4+ and CD8+ T cell count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Marker of Immunological function
Changes of blood oxygen [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Evaluation of Pneumonia change
Side effects in the treatment group [ Time Frame: 28 days ]Number of participants with treatment-related adverse events Change of Clinical symptoms including duration of fever and respiratory [ Time Frame: At Baseline , Day 3, Day 7, Day 10, Day 14, Day 21, Day 28 ]Evaluation of Pneumonia change
Time of nucleic acid turning negative [ Time Frame: 28 days ]Marker for 2019-nCoV
CD4+ and CD8+ T cell count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Marker of Immunological function
Changes of blood oxygen [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Evaluation of Pneumonia change
Side effects in the treatment group [ Time Frame: 28 days ]Number of participants with treatment-related adverse events Time of nucleic acid turning negative [ Time Frame: 28 days ]Marker for 2019-nCoV
CD4+ and CD8+ T cell count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Marker of Immunological function
Changes of blood oxygen [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Evaluation of Pneumonia change
Side effects in the treatment group [ Time Frame: 28 days ]Number of participants with treatment-related adverse events CD4+ and CD8+ T cell count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Marker of Immunological function
Changes of blood oxygen [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Evaluation of Pneumonia change
Side effects in the treatment group [ Time Frame: 28 days ]Number of participants with treatment-related adverse events Changes of blood oxygen [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21 and Day 28 ]Evaluation of Pneumonia change
Side effects in the treatment group [ Time Frame: 28 days ]Number of participants with treatment-related adverse events Side effects in the treatment group [ Time Frame: 28 days ]Number of participants with treatment-related adverse events",24
31,Not yet recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04320615,Clinical Status Assessed Using a 7-Category Ordinal Scale [ Time Frame: Day 28 ],"Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours [ Time Frame: Up to 60 days ]
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to 60 days ]
Incidence of Mechanical Ventilation [ Time Frame: Up to 60 days ]
Ventilator-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Organ Failure-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
Duration of ICU Stay [ Time Frame: Up to 60 days ]
Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to 60 days ]
Incidence of Mechanical Ventilation [ Time Frame: Up to 60 days ]
Ventilator-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Organ Failure-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
Duration of ICU Stay [ Time Frame: Up to 60 days ]
Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Incidence of Mechanical Ventilation [ Time Frame: Up to 60 days ]
Ventilator-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Organ Failure-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
Duration of ICU Stay [ Time Frame: Up to 60 days ]
Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Ventilator-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Organ Failure-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
Duration of ICU Stay [ Time Frame: Up to 60 days ]
Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Organ Failure-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
Duration of ICU Stay [ Time Frame: Up to 60 days ]
Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
Duration of ICU Stay [ Time Frame: Up to 60 days ]
Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Duration of ICU Stay [ Time Frame: Up to 60 days ]
Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Time to Hospital Discharge [ Time Frame: Up to 60 days ]
Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
Serum Concentration of TCZ [ Time Frame: Up to 60 days ] Serum Concentration of TCZ [ Time Frame: Up to 60 days ]",330
32,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04273529,"Time to Clinical recoveryTime to Clinical Recovery (TTCR) [ Time Frame: up to 28 days ]TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria:
Fever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.","All cause mortality [ Time Frame: up to 28 days ]baseline SpO2 during screening, PaO2/FiO2 ＜300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen
Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Time to defervescence [ Time Frame: up to 28 days ]in those with fever at enrolment Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Time to defervescence [ Time Frame: up to 28 days ]in those with fever at enrolment Time to defervescence [ Time Frame: up to 28 days ]in those with fever at enrolment",100
33,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04273581,"Time to Clinical Improvement (TTCI) [ Time Frame: up to 28 days ]TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.","Clinical status [ Time Frame: days 7, 14, 21, and 28 ]Clinical status, assessed by the ordinal scale at fixed time points
Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] All cause mortality [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Frequency of serious adverse drug events [ Time Frame: up to 28 days ]
Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ] Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment [ Time Frame: up to 28 days ]",40
34,Recruiting,Not Applicable,All,"Child, Adult, Older Adult",NCT04323514,In-hospital mortality [ Time Frame: 72 hours ]Change of hospital mortality,"PCR levels [ Time Frame: 72 hours ]Reduction of PCR levels > 50% in comparison with PCR levels at the admission, within 72 hours after the administration
Lactate clearance [ Time Frame: 72 hours ]Change of the lactate clearance
Hospital stay [ Time Frame: 72 hours ]Change of hospital stay days
Symptoms [ Time Frame: 72 hours ]Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)
Positive swab [ Time Frame: 72 hours ]Change of duration of positive swab (nasopharynx and throat)
Tomography imaging [ Time Frame: 72 hours ]Resolution of tomography imaging (example, patches located in the subpleural regions of the lung) Lactate clearance [ Time Frame: 72 hours ]Change of the lactate clearance
Hospital stay [ Time Frame: 72 hours ]Change of hospital stay days
Symptoms [ Time Frame: 72 hours ]Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)
Positive swab [ Time Frame: 72 hours ]Change of duration of positive swab (nasopharynx and throat)
Tomography imaging [ Time Frame: 72 hours ]Resolution of tomography imaging (example, patches located in the subpleural regions of the lung) Hospital stay [ Time Frame: 72 hours ]Change of hospital stay days
Symptoms [ Time Frame: 72 hours ]Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)
Positive swab [ Time Frame: 72 hours ]Change of duration of positive swab (nasopharynx and throat)
Tomography imaging [ Time Frame: 72 hours ]Resolution of tomography imaging (example, patches located in the subpleural regions of the lung) Symptoms [ Time Frame: 72 hours ]Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)
Positive swab [ Time Frame: 72 hours ]Change of duration of positive swab (nasopharynx and throat)
Tomography imaging [ Time Frame: 72 hours ]Resolution of tomography imaging (example, patches located in the subpleural regions of the lung) Positive swab [ Time Frame: 72 hours ]Change of duration of positive swab (nasopharynx and throat)
Tomography imaging [ Time Frame: 72 hours ]Resolution of tomography imaging (example, patches located in the subpleural regions of the lung) Tomography imaging [ Time Frame: 72 hours ]Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)",500
35,Not yet recruiting,Phase 3,All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04315896,"All-cause hospital mortality [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]incidence of all-cause mortality","Length of hospital stay [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]Days from ER admission to hospital discharge
Need of mechanical ventilation [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]need of invasive or non invasive mechanical ventilation
Ventilator free days [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization
Grade 3-4 adverse reaction [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]Adverse Reactions Need of mechanical ventilation [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]need of invasive or non invasive mechanical ventilation
Ventilator free days [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization
Grade 3-4 adverse reaction [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]Adverse Reactions Ventilator free days [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization
Grade 3-4 adverse reaction [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]Adverse Reactions Grade 3-4 adverse reaction [ Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days ]Adverse Reactions",500
36,Not yet recruiting,Not Applicable,All,6 Months to 15 Years   (Child),NCT04318431,Proportion of asymptomatic children or children with mild respiratory symptoms [ Time Frame: 14 days ]Proportion of asymptomatic children or children with mild respiratory symptoms (mildly-symptomatic children) with a positive SARS-Cov2 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on rhino pharyngeal swab in the Ile-de-France region during an epidemic period.,"Confirmed Cov2-SARS cases by age [ Time Frame: 14 days ]The proportion of confirmed Cov2-SARS cases in mildly-symptomatic and asymptomatic children in different age groups (defined as 6-23 months, 2-4 years, 5-9 years, 10-15 years).
Confirmed Cov2-SARS cases by symptoms [ Time Frame: 14 days ]The proportion of confirmed Cov2-SARS cases based on the symptoms presented by the patients
Viral load [ Time Frame: 14 days ]The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) depending on the symptoms and the age of the patients
Other respiratory viruses [ Time Frame: 14 days ]The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive Confirmed Cov2-SARS cases by symptoms [ Time Frame: 14 days ]The proportion of confirmed Cov2-SARS cases based on the symptoms presented by the patients
Viral load [ Time Frame: 14 days ]The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) depending on the symptoms and the age of the patients
Other respiratory viruses [ Time Frame: 14 days ]The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive Viral load [ Time Frame: 14 days ]The viral load of children with SARS-Cov2 positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) depending on the symptoms and the age of the patients
Other respiratory viruses [ Time Frame: 14 days ]The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive Other respiratory viruses [ Time Frame: 14 days ]The proportion of co-infection with other respiratory viruses among children with SARS -Cov2 RT-PCR positive",600
37,Not yet recruiting,Phase 4,All,"18 Years and older   (Adult, Older Adult)",NCT04325061,60-day mortality [ Time Frame: 60 days ]All-cause mortality at 60 days after after enrollment,"Ventilator-free days [ Time Frame: 28 days ]Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment, For patients ventilated 28 days or longer and for subjects who die, VFD is 0.",200
38,Recruiting,Phase 2,All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04280588,The change of pneumonia severity on X-ray images [ Time Frame: 5 day after fingolimod treatment ]The lesion change on X-ray images from day 5 to baseline,The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia; Aged 18 to 85 years; Patients or authorized family members volunteered to participate in this study and signed informed consent.,30
39,"Active, not recruiting",,All,"18 Years to 100 Years   (Adult, Older Adult)",NCT04318301,"Rate of Death [ Time Frame: From date of admission until the date of death from any cause, up to 60 days ]mortality in 28-day","the severity of pneumonia [ Time Frame: From date of admission until the date of discharge or death from any cause, up to 60 days ]evaluate the severity of pneumonia according to CT scans and clinical manifestation",275
40,Withdrawn,Not Applicable,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04293692,"Size of lesion area by chest imaging [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Evaluation of Pneumonia change
Blood oxygen saturation [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Evaluation of Pneumonia change Blood oxygen saturation [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Evaluation of Pneumonia change","Rate of mortality within 28-days [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker for efficacy of treatment
Sequential organ failure assessment [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]0-4 score, the higher the score is, the poor of the prognosis will be.
Side effects in the UC-MSCs treatment group [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Number of participants with treatment-related adverse events
Electrocardiogram, the changes of ST-T interval mostly [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function
Concentration of C-reactive protein C-reactive protein, immunoglobulin [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of infection
CD4+ and CD8+ T cells count [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the myocardial enzymes [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function Sequential organ failure assessment [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]0-4 score, the higher the score is, the poor of the prognosis will be.
Side effects in the UC-MSCs treatment group [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Number of participants with treatment-related adverse events
Electrocardiogram, the changes of ST-T interval mostly [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function
Concentration of C-reactive protein C-reactive protein, immunoglobulin [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of infection
CD4+ and CD8+ T cells count [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the myocardial enzymes [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function Side effects in the UC-MSCs treatment group [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Number of participants with treatment-related adverse events
Electrocardiogram, the changes of ST-T interval mostly [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function
Concentration of C-reactive protein C-reactive protein, immunoglobulin [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of infection
CD4+ and CD8+ T cells count [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the myocardial enzymes [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function Electrocardiogram, the changes of ST-T interval mostly [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function
Concentration of C-reactive protein C-reactive protein, immunoglobulin [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of infection
CD4+ and CD8+ T cells count [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the myocardial enzymes [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function Concentration of C-reactive protein C-reactive protein, immunoglobulin [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of infection
CD4+ and CD8+ T cells count [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the myocardial enzymes [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function CD4+ and CD8+ T cells count [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the myocardial enzymes [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α) [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Marker of Immunology and inflammation
Concentration of the myocardial enzymes [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function Concentration of the myocardial enzymes [ Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8 ]Markers of the heart function",0
41,Not yet recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04317040,"Improvement of COVID-19 disease status [ Time Frame: 14 days ]Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status ""severe"" to ""moderate/mild""; or improvement from ""scale 3 or 4"" to ""scale 5 or higher"" based on NIAID ordinal scales.","Conversion rate of clinical status at Day 8 [ Time Frame: 7 days ]Conversion rate of clinical status on days 8 (proportion of subjects who changed from ""severe"" to ""moderate or mild"", or the improvement from ""scale 3 or 4"" to ""scale 5 or higher"" on NIAID ordinal scale)
Conversion rate of clinical status at Day 15 [ Time Frame: 14 days ]Conversion rate of clinical status on days 15 (proportion of subjects who changed from ""severe"" to ""moderate or mild"", or the improvement from ""scale 3 or 4"" to ""scale 5 or higher"" on NIAID ordinal scale)
Hospital discharge time [ Time Frame: 14 days ]The discharge time or NEWS2 (National Early Warning Score 2) of ≤2 is maintained for 24 hours
All cause of death [ Time Frame: 14 days ]All cause of death
Duration of mechanical ventilation [ Time Frame: 14 days ]Duration of mechanical ventilation (IMV, NIV) (days)
Duration of pressors [ Time Frame: 14 days ]Duration of pressors (days)
Duration of ECMO [ Time Frame: 14 days ]Duration of extracorporeal membrane oxygenation (days)
Duration of oxygen therapy [ Time Frame: 14 days ]Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)
Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood Conversion rate of clinical status at Day 15 [ Time Frame: 14 days ]Conversion rate of clinical status on days 15 (proportion of subjects who changed from ""severe"" to ""moderate or mild"", or the improvement from ""scale 3 or 4"" to ""scale 5 or higher"" on NIAID ordinal scale)
Hospital discharge time [ Time Frame: 14 days ]The discharge time or NEWS2 (National Early Warning Score 2) of ≤2 is maintained for 24 hours
All cause of death [ Time Frame: 14 days ]All cause of death
Duration of mechanical ventilation [ Time Frame: 14 days ]Duration of mechanical ventilation (IMV, NIV) (days)
Duration of pressors [ Time Frame: 14 days ]Duration of pressors (days)
Duration of ECMO [ Time Frame: 14 days ]Duration of extracorporeal membrane oxygenation (days)
Duration of oxygen therapy [ Time Frame: 14 days ]Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)
Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood Hospital discharge time [ Time Frame: 14 days ]The discharge time or NEWS2 (National Early Warning Score 2) of ≤2 is maintained for 24 hours
All cause of death [ Time Frame: 14 days ]All cause of death
Duration of mechanical ventilation [ Time Frame: 14 days ]Duration of mechanical ventilation (IMV, NIV) (days)
Duration of pressors [ Time Frame: 14 days ]Duration of pressors (days)
Duration of ECMO [ Time Frame: 14 days ]Duration of extracorporeal membrane oxygenation (days)
Duration of oxygen therapy [ Time Frame: 14 days ]Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)
Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood All cause of death [ Time Frame: 14 days ]All cause of death
Duration of mechanical ventilation [ Time Frame: 14 days ]Duration of mechanical ventilation (IMV, NIV) (days)
Duration of pressors [ Time Frame: 14 days ]Duration of pressors (days)
Duration of ECMO [ Time Frame: 14 days ]Duration of extracorporeal membrane oxygenation (days)
Duration of oxygen therapy [ Time Frame: 14 days ]Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)
Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood Duration of mechanical ventilation [ Time Frame: 14 days ]Duration of mechanical ventilation (IMV, NIV) (days)
Duration of pressors [ Time Frame: 14 days ]Duration of pressors (days)
Duration of ECMO [ Time Frame: 14 days ]Duration of extracorporeal membrane oxygenation (days)
Duration of oxygen therapy [ Time Frame: 14 days ]Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)
Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood Duration of pressors [ Time Frame: 14 days ]Duration of pressors (days)
Duration of ECMO [ Time Frame: 14 days ]Duration of extracorporeal membrane oxygenation (days)
Duration of oxygen therapy [ Time Frame: 14 days ]Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)
Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood Duration of ECMO [ Time Frame: 14 days ]Duration of extracorporeal membrane oxygenation (days)
Duration of oxygen therapy [ Time Frame: 14 days ]Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)
Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood Duration of oxygen therapy [ Time Frame: 14 days ]Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)
Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood Length of hospital stay [ Time Frame: 14 days ]Length of hospital stay (days)
Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood Absolute lymphocyte count [ Time Frame: 14 days ]Changes of absolute lymphocyte count in peripheral blood",230
42,Recruiting,"Phase 1
Phase 2",All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04288102,"Size of lesion area and severity of pulmonary fibrosis by chest CT [ Time Frame: At Baseline , Day 6, Day 10, Day 14, Day 28 and Day 90 ]Evaluation of Pneumonia Improvement","Proportion of patients in each classification of clinical critical treatment index [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
No limitation of activities, discharged from hospital =Score 1; Hospitalized, no oxygen therapy=Score 2; Oxygen by mask or nasal prongs-Score 3; Non-invasive ventilation or high-flow oxygen=Score 4; Mechanical ventilation or ECMO=Score 5; Death=Score 6.
Oxygenation index( PaO2/FiO2) [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Duration of oxygen therapy(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Duration of hospitalization(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Blood oxygen saturation [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
CD4+ T cell count and cytokine level [ Time Frame: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 ]Marker of Immunological function
Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6，Day 10, Day 14, Day 21, Day 28, Day 90 ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0 Oxygenation index( PaO2/FiO2) [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Duration of oxygen therapy(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Duration of hospitalization(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Blood oxygen saturation [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
CD4+ T cell count and cytokine level [ Time Frame: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 ]Marker of Immunological function
Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6，Day 10, Day 14, Day 21, Day 28, Day 90 ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0 Duration of oxygen therapy(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Duration of hospitalization(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Blood oxygen saturation [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
CD4+ T cell count and cytokine level [ Time Frame: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 ]Marker of Immunological function
Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6，Day 10, Day 14, Day 21, Day 28, Day 90 ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0 Duration of hospitalization(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
Blood oxygen saturation [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
CD4+ T cell count and cytokine level [ Time Frame: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 ]Marker of Immunological function
Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6，Day 10, Day 14, Day 21, Day 28, Day 90 ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0 Blood oxygen saturation [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
CD4+ T cell count and cytokine level [ Time Frame: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 ]Marker of Immunological function
Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6，Day 10, Day 14, Day 21, Day 28, Day 90 ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0 CD4+ T cell count and cytokine level [ Time Frame: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 ]Marker of Immunological function
Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6，Day 10, Day 14, Day 21, Day 28, Day 90 ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0 Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6，Day 10, Day 14, Day 21, Day 28, Day 90 ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0",90
43,Not yet recruiting,Phase 4,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04286503,"Data management The electronic data collection system (EDC) will be used in this study for the collection and management of the study data to ensure the traceability of the clinical trial data; the data management process shall comply with the GCP specification to ensure the authenticity, integrity and accuracy of clinical trial data. The main data management processes are listed below. For other details, please refer to the data management plan (DMP).
DMP is written by the data manager (DM) as the guiding document for data management. The data management work will be carried out according to the time, content and method defined by DMP.
1.1Design and establishment of database The data manager designs and constructs the database according to the trial protocol, and sets up the logic verification according to the data validation plan (DVP), which i released for use after passing the test and being approved by the investigator.
1.2Data entry The investigator or a person authorized by the investigator shall timely complete the online data entry after the subject visit, use the printed eCRF form first if necessary, and, in case of data correction in eCRF if required, fill in the reason for the data modification according to the system prompt. The logic validation program of the EDC system will logically check the input data and question the problem data, so as to facilitate the modification or interpretation by the investigator or the person authorized by the investigator.
1.3Source data validation (SDV) The investigator logs on EDC on the study site, 100% check the consistency of eCRF data and source data, and ask questions at any time in case of any problem.
1.4Data cleaning After investigator or the person authorized by the investigator enters the data to EDC according to the protocol requirements, the data manager and medical personnel shall review the data. The problems in the review shall be answered by the investigator or the person authorized by the investigator in the form of question until the question is closed.
1.5Medical coding The medical coder performs medical coding, including combined drugs and adverse events. Adverse events will be coded according to the MedDRA (20.0 or above) dictionary and the combined drugs will be classified by WHO ATC.
During the coding process, DM can question the investigator online in real time about failure of coding caused by improper, inaccurate or ambiguous medical terms provided.
A medical review is required for the medical coding before the database lock. 1.6External data management NA 1.7Data review meeting The study leader, statistician and data manager make the data review before statistical analysis to review the subject completion, protocol violation, adverse events, analysis data sets (including FAS, PPS and SS) to determine the attribution of each subject, judgment of missing value and treatment of outliers. Decisions made on the review meeting cannot be modified after the database lock, and any decisions must be documented.
1.8Electronic signature of investigator After the database is frozen, the investigator conducts electronic signature verification and shall sign the name again in case of data revision after signature.
1.9Data lock and export After the data in the database meets the quality requirements, a written approval document of database lock is signed by the data manager, statistical analyst and investigator representative according to the database lock procedures, exported by the data manager to the database of specified format and submitted to the statistician for statistical analysis. Statistical analysis See the ""Statistical analysis plan"" for the details of the statistical analysis. The statistician and the principal investigator finalize the plan according to the data characteristics through discussion before the database lock. This protocol only describes the basic statistical analysis content, and the actual content shall be subject to the statistical analysis plan.
2.1Analysis data set 2.1.1Full Analysis Set (FAS): a set of all cases randomized to use the study drug at least once.
2.1.2Per Protocol Set (PPS): a data set generated by subjects who have fully complied with the trial protocol, including treatment received, availability of primary endpoint measurement, and no significant violation of the trial protocol. Cases withdrawn due to inefficacy will also be included in PPS. PPS will be subject to the final classification of the data audit report.
2.1.3Safety Set (SS): a set of subjects who receive at least one treatment with a safety evaluation after randomization.
2.2Missing data processing method 2.2.1The subjects who have missing primary efficiency indicators are filled in according to the treatment failure, that is, the pathogen nucleic acid testing in throat swabs, urine and stool on Days 7-14 after administration does not convert to negative. Unless otherwise specified, the secondary efficiency indicators shall be included as observed data in the statistical analysis, and the missing data shall not be filled in.
2.2.2The safety data shall not be filled in. 2.3Statistical method 2.3.1General principle
Description of statistics:
The primary indicators collected in this study are described with statistical method. Quantitative indicators are described by means of mean, standard deviation, median, quartile, maximum, minimum and the like; qualitative indicators are described by frequency, percentage and the like.
Statistical test:
Unless otherwise specified, the statistical significance level is 0.05 by two-sided test (one-sided 0.025) and the 95% confidence interval shall be provided for the estimation of inter-group variance parameters.
2.3.2Characteristics of cases Subject distribution The population and the number of enrolled and completed cases in each center are listed, and three analysis data sets (FAS, PPS, SS) are determined.
A detailed list of the data set categories is made. The number and ratio of subjects who are randomly enrolled, complete the trial, and withdraw from the trial early and the reasons are calculated.
The subject distribution flow chart is plotted. General information and baseline characteristics The demographic information, previous medication history and history of other diseases of the patients are described with statistical method. General information and baseline characteristics are described based on FAS.
2.3.3Analysis of drug exposure and drug combination Analysis based on SS. The drug exposure, dose intensity and exposure time of each group are calculated and subject to descriptive statistical analysis.
The drug combination is coded by WHO ATC and summarized according to the ATC secondary classification and PT. The number and ratio of cases are calculated.
2.3.4Efficiency analysis Analysis based on FAS and PPS.
Primary efficiency indicators:
The primary effective indicators are complete antipyresis time, pulmonary imaging improvement indicators, and negative conversion ratio of pathogen nucleic acid testing in throat swabs, urine and stool on Days 7-14 after administration.The non-inferiority evaluation is based on FAS. The statistical significance level is set to one-sided 0.025 and the non-inferiority critical value is set to -10%. The negative conversion ratio of pathogen nucleic acid testing in throat swabs, urine and stool on Days 7-14 after administration in the trial group and positive control group is calculated respectively. The negative conversion ratio difference (trial group - control group) between the trial group and positive control group as well as the two-sided 95% confidence interval (95%CI) are calculated. The confidence interval is estimated by Miettinen-Nurminen. If the lower limit of 95% confidence interval for the negative conversion ratio difference between the trial group and control group is greater than -10%, it is considered that the trial drug for the indication is not inferior to the positive control drug. Given that the non-inferiority hypothesis is true, if it is further obtained that the lower limit of 95% confidence interval for the negative conversion ratio difference between the trial group and control group is greater than 0, it is considered that the trial drug for the indication is superior to the positive control drug. The inter-group ratio difference and confidence interval estimation results after the site effect control will be provided simultaneously as the sensitivity analysis and the sites with few subjects may be combined before analysis.
Secondary efficiency indicators:
The secondary efficiency indicators include negative conversion ratio of pathogen nucleic acid testing on Day 1, 3, 5, 7, 10 and 14 after administration, negative conversion time, immune-related indicators (lymphocyte count, lymphocyte percentage, counts and percentages of CD4 and CD8), SOFA score, white blood cell count and C-reactive protein. The secondary efficiency indicators are subject to descriptive statistical analysis according to the data type. Where, for the quantitative data, the observed values in each visit and the changes in the observed values from baseline after treatment are analyzed descriptively and provided with the inter-group difference estimate value (trial group - control group) of the changes in indicators in different visits from baseline and its 95% confidence interval; for the qualitative data, the indicators in different visits are described in the form of a frequency table (frequency and percentage) and provided with the inter-group ratio difference and confidence interval estimate; for the survival data, such as the negative conversion time of pathogen nucleic acid testing and complete antipyresis time, the median complete antipyresis time and its 95% confidence interval in each group are calculated by Kaplan-Meier, the information on the subject deletions at the end of the study is provided and the survivorship curve is provided. The hazard ratio HR and its 90% confidence interval of the trail group and the control group are estimated by Cox proportional hazards regression.
2.3.5Safety analysis SS data sets are used for safety analysis. Adverse events are coded according to the MedDRA. The occurrence of adverse events/reactions, serious adverse events/reactions and adverse events/reactions resulting in drop out is summarized and analyzed in the form of a frequency table (number of cases, case, and incidence).
The occurrence of varying severity orders of adverse events/reactions, serious adverse events/reactions and adverse events/reactions resulting in drop out is subject to descriptive statistical analysis in the form of a frequency table (number of cases, case, and incidence) according to SOC and PT.
A detailed list of various adverse events/reactions, serious adverse events/reactions and adverse events/reactions resulting in drop out is made.
Changes in the clinical significance determination of laboratory indicators, ECG and physical examination at each visit after administration and baseline test results are described in the form of crosstab.
The laboratory indexes and vital signs examination are subject to descriptive statistical analysis according to trial grouping and visits.
A detailed list of laboratory indexes, ECG, and clinically significant physical abnormalities is made.
2.4Analysis software Use the software SAS with version 9.4 or above for analysis. 2.5Interim analysis and multiplicity control In order to obtain relevant study results as soon as possible to support follow-up scientific research and clinical practice, this study plans to conduct staged efficacy and safety data analysis at the sample size of 65, 130 and 260 cases. The study will be terminated immediately if the clinical efficacy of the study drug is poor, . No multiplicity control is made. Study management 3.1 Study management structure This study is planned to be conducted simultaneously in XX clinical study sites in China.","Fever to normal time (day) [ Time Frame: 30 days ]Fever to normal time (day)
Pulmonary inflammation resolution time (HRCT) (day) [ Time Frame: 30 days ]Pulmonary inflammation resolution time (HRCT) (day)
Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment [ Time Frame: 30 days ]Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment Pulmonary inflammation resolution time (HRCT) (day) [ Time Frame: 30 days ]Pulmonary inflammation resolution time (HRCT) (day)
Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment [ Time Frame: 30 days ]Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment [ Time Frame: 30 days ]Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment",520
44,Recruiting,Not Applicable,All,"18 Years and older   (Adult, Older Adult)",NCT04273321,"the incidence of treatment failure in 14 days [ Time Frame: 14 days ]The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.","clinical cure incidence in 14 days [ Time Frame: 14 days ]The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.
the duration of virus change to negative [ Time Frame: 30 days ]the duration from admission to virus negative
mortality at day 30 [ Time Frame: 30 days ]the patient die in 30 days
ICU admission rate in 30 days [ Time Frame: 30 days ]the patients transform to ICU because of clinical deteriorate in 30 days the duration of virus change to negative [ Time Frame: 30 days ]the duration from admission to virus negative
mortality at day 30 [ Time Frame: 30 days ]the patient die in 30 days
ICU admission rate in 30 days [ Time Frame: 30 days ]the patients transform to ICU because of clinical deteriorate in 30 days mortality at day 30 [ Time Frame: 30 days ]the patient die in 30 days
ICU admission rate in 30 days [ Time Frame: 30 days ]the patients transform to ICU because of clinical deteriorate in 30 days ICU admission rate in 30 days [ Time Frame: 30 days ]the patients transform to ICU because of clinical deteriorate in 30 days",400
45,Not yet recruiting,,All,"18 Years to 90 Years   (Adult, Older Adult)",NCT04298814,"Other: severe covid-19 pneumonia with ET
severe covid-19 pneumonia undergoing endotracheal intubation","Success rate of intubation [ Time Frame: the time span between 1hour before intubation and 24h after intubation ]The data of Success rate of intubation with severe COVID-19 pneumonia patients
Infection rate of Anesthesiologist [ Time Frame: the time span between 1hour before intubation and 14days after intubation ]Infection rate of Anesthesiologist who performed the endotracheal intubation for severe COVID-19 pneumonia patients Infection rate of Anesthesiologist [ Time Frame: the time span between 1hour before intubation and 14days after intubation ]Infection rate of Anesthesiologist who performed the endotracheal intubation for severe COVID-19 pneumonia patients",120
46,"Active, not recruiting","Phase 2
Phase 3",All,"18 Years and older   (Adult, Older Adult)",NCT04278963,"Mean clinical recovery time (hours) [ Time Frame: up to 28 days ]The clinical recovery time is defined as the time from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours.
Normalisation and alleviation criteria:
(1) Fever: ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic;(2)Respiratory rate - ≤24/minute on room air; 3) Oxygen saturation - >94% on room air; (4) Cough - mild or absent on a patient reported scale (cough symptoms score ≤ 2 points).","Time to CoVID-19 RT-PCR negative in upper respiratory tract specimen [ Time Frame: up to 28 days ]
Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Time to defervescence (in those with fever at enrolment) [ Time Frame: up to 28 days ]
Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate) [ Time Frame: up to 28 days ]
Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnea at enrollment rated as severe or moderate) [ Time Frame: up to 28 days ]
Frequency of requirement for supplemental oxygen or non-invasive ventilation [ Time Frame: up to 28 days ]
Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Severe case incidence [ Time Frame: up to 28 days ]Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Change (reduction) in CoVID-19 viral load in upper respiratory tract specimen as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Time to defervescence (in those with fever at enrolment) [ Time Frame: up to 28 days ]
Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate) [ Time Frame: up to 28 days ]
Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnea at enrollment rated as severe or moderate) [ Time Frame: up to 28 days ]
Frequency of requirement for supplemental oxygen or non-invasive ventilation [ Time Frame: up to 28 days ]
Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Severe case incidence [ Time Frame: up to 28 days ]Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Time to defervescence (in those with fever at enrolment) [ Time Frame: up to 28 days ]
Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate) [ Time Frame: up to 28 days ]
Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnea at enrollment rated as severe or moderate) [ Time Frame: up to 28 days ]
Frequency of requirement for supplemental oxygen or non-invasive ventilation [ Time Frame: up to 28 days ]
Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Severe case incidence [ Time Frame: up to 28 days ]Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate) [ Time Frame: up to 28 days ]
Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnea at enrollment rated as severe or moderate) [ Time Frame: up to 28 days ]
Frequency of requirement for supplemental oxygen or non-invasive ventilation [ Time Frame: up to 28 days ]
Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Severe case incidence [ Time Frame: up to 28 days ]Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnea at enrollment rated as severe or moderate) [ Time Frame: up to 28 days ]
Frequency of requirement for supplemental oxygen or non-invasive ventilation [ Time Frame: up to 28 days ]
Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Severe case incidence [ Time Frame: up to 28 days ]Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Frequency of requirement for supplemental oxygen or non-invasive ventilation [ Time Frame: up to 28 days ]
Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Severe case incidence [ Time Frame: up to 28 days ]Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Frequency of respiratory progression [ Time Frame: up to 28 days ]Defined as: SPO2≤ 93% on room air or PaO2/FiO2≤ 300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Severe case incidence [ Time Frame: up to 28 days ]Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Severe case incidence [ Time Frame: up to 28 days ]Severe case is defined as respiratory rate ≥30/minute on room air；or Oxygen saturation - ≤94% on room air；or PaO2/FiO2≤300mmHg.
Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Proportion of re-hospitalization or admission to ICU [ Time Frame: up to 28 days ]
All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] All-cause mortality [ Time Frame: up to 28 days ]
Frequency of serious adverse events [ Time Frame: up to 28 days ] Frequency of serious adverse events [ Time Frame: up to 28 days ]",300
47,Not yet recruiting,"Phase 2
Phase 3",All,"18 Years and older   (Adult, Older Adult)",NCT04318444,"Number of participants with symptomatic, lab-confirmed COVID-19. [ Time Frame: Date of enrollment to 14 days post-enrollment date ]This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.","Household contact of index case: currently residing in the same household as an individual evaluated at NYP via outpatient, emergency department (ED), or inpatient services who (1) test positive for COVID-19, or (2) are defined as suspected cases, or persons under investigations (PUI), by the treating physician. Willing to take study drug as directed for 5 days.",1600
48,Not yet recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04318015,"Symptomatic COVID-19 infection rate [ Time Frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start ]Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.","Symptomatic non-COVID viral infection rate [ Time Frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start ]Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.
Days of labor absenteeism [ Time Frame: From date of randomization until study completion 60 days after treatment start ]Number of days absent from labor due to COVID-19 symptomatic infection
Rate of labor absenteeism [ Time Frame: From date of randomization until study completion 60 days after treatment start ]Absenteeism from labor rate due to COVID-19 symptomatic infection
Rate of severe respiratory COVID-19 disease in healthcare personnel [ Time Frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start ]Rate of severe respiratory COVID-19 disease in healthcare personnel Days of labor absenteeism [ Time Frame: From date of randomization until study completion 60 days after treatment start ]Number of days absent from labor due to COVID-19 symptomatic infection
Rate of labor absenteeism [ Time Frame: From date of randomization until study completion 60 days after treatment start ]Absenteeism from labor rate due to COVID-19 symptomatic infection
Rate of severe respiratory COVID-19 disease in healthcare personnel [ Time Frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start ]Rate of severe respiratory COVID-19 disease in healthcare personnel Rate of labor absenteeism [ Time Frame: From date of randomization until study completion 60 days after treatment start ]Absenteeism from labor rate due to COVID-19 symptomatic infection
Rate of severe respiratory COVID-19 disease in healthcare personnel [ Time Frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start ]Rate of severe respiratory COVID-19 disease in healthcare personnel Rate of severe respiratory COVID-19 disease in healthcare personnel [ Time Frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start ]Rate of severe respiratory COVID-19 disease in healthcare personnel",400
49,Withdrawn,Not Applicable,All,"14 Years to 70 Years   (Child, Adult, Older Adult)",NCT04251767,microbiota transplantation fecal microbiota transplantation,"Number of participants with improvement from severe type to common type [ Time Frame: 2 weeks ]Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia;
Severe type (meeting any of the following）: (1) Respiratory distress，respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%；(3)PaO2/FiO2 ≤ 300mmHg.
Critically severe type (meeting any of the following）: (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.",0
50,Not yet recruiting,Phase 3,All,"16 Years to 100 Years   (Child, Adult, Older Adult)",NCT04303299,SARS-CoV-2 eradication time [ Time Frame: Up to 24 weeks ]Eradication of nasopharyngeal SARS-CoV-2,"Number of patient with Death [ Time Frame: Up to 24 weeks ]Any death after treatment adjusted by initial severity in each arm
Number of patient with Recovery adjusted by initial severity in each arm [ Time Frame: Up to 24 weeks ]Normal pulmonary function, normal O2 saturation after treatment Adjusted by initial severity in each arm
Number of day With ventilator dependent adjusted by initial severity in each arm [ Time Frame: Up to 24 weeks ]Number of day with ventilator assistant
Number of patient developed Acute Respiratory Distress Syndrome After treatment [ Time Frame: Up to 24 weeks ]Number of patient developed new ARDS Number of patient with Recovery adjusted by initial severity in each arm [ Time Frame: Up to 24 weeks ]Normal pulmonary function, normal O2 saturation after treatment Adjusted by initial severity in each arm
Number of day With ventilator dependent adjusted by initial severity in each arm [ Time Frame: Up to 24 weeks ]Number of day with ventilator assistant
Number of patient developed Acute Respiratory Distress Syndrome After treatment [ Time Frame: Up to 24 weeks ]Number of patient developed new ARDS Number of day With ventilator dependent adjusted by initial severity in each arm [ Time Frame: Up to 24 weeks ]Number of day with ventilator assistant
Number of patient developed Acute Respiratory Distress Syndrome After treatment [ Time Frame: Up to 24 weeks ]Number of patient developed new ARDS Number of patient developed Acute Respiratory Distress Syndrome After treatment [ Time Frame: Up to 24 weeks ]Number of patient developed new ARDS",80
51,Recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04322188,"Age (by decades) Sex (M/F) P/F fraction (<100, 100-150 or >150) at baseline Antiviral therapy Procedures outlined in this protocol are based on the compassionate use program, where patients are managed as per clinicians' best judgement and best practice. No clinical procedures are required by this observational protocol. Data on the procedures already performed during the routine diagnosis and treatment of COVID-19 patients will be collected. The list of clinical and laboratory parameters is provided to direct data collection for this observational study (as available in the medical records).","Cohort A: reduction of the need of invasive ventilation or 30-day mortality [ Time Frame: 30 days ]reduction of the need of invasive ventilation or 30-day mortality
Cohort B: reduction of mortality [ Time Frame: 30 days ]reduction of mortality Cohort B: reduction of mortality [ Time Frame: 30 days ]reduction of mortality",50
52,Not yet recruiting,,All,"Child, Adult, Older Adult",NCT04323644,30-day mortality [ Time Frame: 30 days ]Death up to 30-days post surgery,"7-day mortality [ Time Frame: 7 days post surgery ]Death up to 7-days post surgery
30-day reoperation [ Time Frame: Up to 30-days post surgery ]Reoperation up to 30-days post surgery
Postoperative ICU admission [ Time Frame: Up to 30 days post surgery ]Admission to ICU post surgery
Postoperative respiratory failure [ Time Frame: Up to 30 days post surgery ]Respiratory failure post surgery
Postoperative acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post surgery ]Acute respiratory distress syndrome post surgery
Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]Sepsis post surgery 30-day reoperation [ Time Frame: Up to 30-days post surgery ]Reoperation up to 30-days post surgery
Postoperative ICU admission [ Time Frame: Up to 30 days post surgery ]Admission to ICU post surgery
Postoperative respiratory failure [ Time Frame: Up to 30 days post surgery ]Respiratory failure post surgery
Postoperative acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post surgery ]Acute respiratory distress syndrome post surgery
Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]Sepsis post surgery Postoperative ICU admission [ Time Frame: Up to 30 days post surgery ]Admission to ICU post surgery
Postoperative respiratory failure [ Time Frame: Up to 30 days post surgery ]Respiratory failure post surgery
Postoperative acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post surgery ]Acute respiratory distress syndrome post surgery
Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]Sepsis post surgery Postoperative respiratory failure [ Time Frame: Up to 30 days post surgery ]Respiratory failure post surgery
Postoperative acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post surgery ]Acute respiratory distress syndrome post surgery
Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]Sepsis post surgery Postoperative acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post surgery ]Acute respiratory distress syndrome post surgery
Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]Sepsis post surgery Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]Sepsis post surgery",1000
53,Not yet recruiting,Early Phase 1,All,"18 Years and older   (Adult, Older Adult)",NCT04319731,Acute care - Nebulized amniotic fluid every 24 hours for 5 days (3mL) ICU - Nebulized amniotic fluid every 24 hours for 5 days (3mL) plus intravenous amniotic fluid every 24 hours for 5 days (6mL),"Ventilator Free Days [ Time Frame: Measured from hospital admission day 60 after admission. ]Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation.
Duration of supplemental oxygen use [ Time Frame: Measured from hospital admission to day 60. ]Duration from hospital admission until cessation of supplemental oxygen use. Measured only among patients who do not receive invasive mechanical ventilation. Duration of supplemental oxygen use [ Time Frame: Measured from hospital admission to day 60. ]Duration from hospital admission until cessation of supplemental oxygen use. Measured only among patients who do not receive invasive mechanical ventilation.",10
54,Not yet recruiting,Phase 3,All,"5 Years to 75 Years   (Child, Adult, Older Adult)",NCT04323345,"Rate of recovery from positive to negative swaps [ Time Frame: 14 days ]Percentage of patients turned from positive to negative swaps at day 14
Fever to normal temperature in days [ Time Frame: 14 days ]Number of days till no fever
Resolution of lung inflammation in CT or X ray [ Time Frame: 30 days ]Number of days till lungs recovery in chest X ray or CT Fever to normal temperature in days [ Time Frame: 14 days ]Number of days till no fever
Resolution of lung inflammation in CT or X ray [ Time Frame: 30 days ]Number of days till lungs recovery in chest X ray or CT Resolution of lung inflammation in CT or X ray [ Time Frame: 30 days ]Number of days till lungs recovery in chest X ray or CT","30 days mortality rate [ Time Frame: 30 days ]mortality rate in each group at 30 days
Number of days till reaching negative swab results [ Time Frame: 30 days ]Number of days from initiation of intervention till changing of the swap test result from positive to negative Number of days till reaching negative swab results [ Time Frame: 30 days ]Number of days from initiation of intervention till changing of the swap test result from positive to negative",1000
55,Not yet recruiting,Not Applicable,All,"18 Years and older   (Adult, Older Adult)",NCT04324190,"to compare the intervention effects across modules and chapters of the online support program, including between module comparison with an unspecific, control (comparator) module: ""general information on the corona virus"" and its unspecific chapters; to estimate the effects of selected modules on additional outcomes (e.g. physical activity, and schooling related factors); to describe the magnitude and course of psychosocial stress, mental health and related factors in the context of the COVID-19 pandemic; to estimate and predict which subjects profit most from specific parts of the program.",online intervention guided online support,600
56,Withdrawn,,All,"18 Years to 100 Years   (Adult, Older Adult)",NCT04272710,"Occupancy rate in the intensive care unit (ICU) [ Time Frame: up to 28 days ]The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.
Mechanical Ventilation [ Time Frame: up to 28 days ]The number of patients requiring mechanical ventilation.
Death [ Time Frame: up to 28 days ]The number of patients who died of 2019-nCoV infection. Mechanical Ventilation [ Time Frame: up to 28 days ]The number of patients requiring mechanical ventilation.
Death [ Time Frame: up to 28 days ]The number of patients who died of 2019-nCoV infection. Death [ Time Frame: up to 28 days ]The number of patients who died of 2019-nCoV infection.","All cause mortality [ Time Frame: up to 28 days ]The number of died 2019-nCoV infected patients from any cause.
Time from onset of symptoms to main outcome and its components [ Time Frame: up to 28 days ]Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.
Time to Clinical Recovery [ Time Frame: up to 28 days ]Time to Clinical Recovery Time from onset of symptoms to main outcome and its components [ Time Frame: up to 28 days ]Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.
Time to Clinical Recovery [ Time Frame: up to 28 days ]Time to Clinical Recovery Time to Clinical Recovery [ Time Frame: up to 28 days ]Time to Clinical Recovery",0
57,Not yet recruiting,,All,"up to 18 Years   (Child, Adult)",NCT04270383,"The cure rate of 2019-nCoV. [ Time Frame: 6 months ]Percentage
The improvement rate of 2019-nCoV. [ Time Frame: 6 months ]Percentage
The incidence of long-term adverse outcomes. [ Time Frame: 6 months ] The improvement rate of 2019-nCoV. [ Time Frame: 6 months ]Percentage
The incidence of long-term adverse outcomes. [ Time Frame: 6 months ] The incidence of long-term adverse outcomes. [ Time Frame: 6 months ]","Duration of fever [ Time Frame: 2 weeks ]Days
Duration of respiratory symptoms [ Time Frame: 2 weeks ]Days
Duration of hospitalization [ Time Frame: 2 weeks ]Days
Number of participant(s) need intensive care [ Time Frame: 2 weeks ]
Number of participant(s) with acute respiratory distress syndrome [ Time Frame: 2 weeks ]
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. [ Time Frame: 2 weeks ]
Number of participant(s) who died during the trial [ Time Frame: 10 months ] Duration of respiratory symptoms [ Time Frame: 2 weeks ]Days
Duration of hospitalization [ Time Frame: 2 weeks ]Days
Number of participant(s) need intensive care [ Time Frame: 2 weeks ]
Number of participant(s) with acute respiratory distress syndrome [ Time Frame: 2 weeks ]
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. [ Time Frame: 2 weeks ]
Number of participant(s) who died during the trial [ Time Frame: 10 months ] Duration of hospitalization [ Time Frame: 2 weeks ]Days
Number of participant(s) need intensive care [ Time Frame: 2 weeks ]
Number of participant(s) with acute respiratory distress syndrome [ Time Frame: 2 weeks ]
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. [ Time Frame: 2 weeks ]
Number of participant(s) who died during the trial [ Time Frame: 10 months ] Number of participant(s) need intensive care [ Time Frame: 2 weeks ]
Number of participant(s) with acute respiratory distress syndrome [ Time Frame: 2 weeks ]
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. [ Time Frame: 2 weeks ]
Number of participant(s) who died during the trial [ Time Frame: 10 months ] Number of participant(s) with acute respiratory distress syndrome [ Time Frame: 2 weeks ]
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. [ Time Frame: 2 weeks ]
Number of participant(s) who died during the trial [ Time Frame: 10 months ] Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. [ Time Frame: 2 weeks ]
Number of participant(s) who died during the trial [ Time Frame: 10 months ] Number of participant(s) who died during the trial [ Time Frame: 10 months ]",500
58,Not yet recruiting,"Phase 2
Phase 3",All,"30 Years to 79 Years   (Adult, Older Adult)",NCT04324021,Treatment success [ Time Frame: Up to Day 15 ]Defined as the proportion of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO),"Time to mechanical ventilation [ Time Frame: Date of randomization to date of mechanical ventilation ]Measured in days
Change from baseline in Modified Early Warning system score [ Time Frame: Baseline, Day 15 ]Measured in total score
Change from baseline in resting peripheral capillary oxygen saturation (SpO2) [ Time Frame: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15 ]Measured in percent (%)
Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) [ Time Frame: Baseline, Day 15 ]Measured in percent (%)
Change of pH in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of oxygen tension (pO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of potassium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Modified Early Warning system score [ Time Frame: Baseline, Day 15 ]Measured in total score
Change from baseline in resting peripheral capillary oxygen saturation (SpO2) [ Time Frame: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15 ]Measured in percent (%)
Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) [ Time Frame: Baseline, Day 15 ]Measured in percent (%)
Change of pH in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of oxygen tension (pO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of potassium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in resting peripheral capillary oxygen saturation (SpO2) [ Time Frame: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15 ]Measured in percent (%)
Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) [ Time Frame: Baseline, Day 15 ]Measured in percent (%)
Change of pH in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of oxygen tension (pO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of potassium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) [ Time Frame: Baseline, Day 15 ]Measured in percent (%)
Change of pH in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of oxygen tension (pO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of potassium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of pH in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of oxygen tension (pO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of potassium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of oxygen tension (pO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of potassium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of oxygen tension (pO2) in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of potassium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of potassium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of sodium in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of chloride in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of lactic acid in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of hemoglobin in hemogasanalysis from baseline [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in oxygen supplementation [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in l/min
Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change of findings of high-resolution computed tomography (CT) scan of the chest [ Time Frame: Screening, Day 15 ]Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Ferritin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in lactate dehydrogenase (LDH) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in D-dimers [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in White Blood Cells with differential counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Red Blood Counts [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Hemoglobin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Platelet count [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Fibrinogen [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Complement factors C3/C4 [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Prothrombin time [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Cardiac troponin [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in total bilirubin levels [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in C-Reactive Protein [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Change from baseline in Creatinine [ Time Frame: Baseline, Days 4, 7, 10, 13 and 15 ]Measured in local units
Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Overall survival [ Time Frame: Weeks 6 and 10 ]Confirmation of death
Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days Time to hospital discharge [ Time Frame: Weeks 6 and 10 ]Measured in days",54
59,Completed,,All,"18 Years and older   (Adult, Older Adult)",NCT04292964,all-cause mortality [ Time Frame: 30 days ],"all-cause mortality [ Time Frame: 15 days ]
Severe state [ Time Frame: 15 days ]Criteria for severe or critical ill conditions: Respiratory rate >=30/min; or Rest SPO2<=93%; or PaO2/FiO2<=300mmHg. Severe state [ Time Frame: 15 days ]Criteria for severe or critical ill conditions: Respiratory rate >=30/min; or Rest SPO2<=93%; or PaO2/FiO2<=300mmHg.",201
60,Completed,,All,"18 Years and older   (Adult, Older Adult)",NCT04316299,"Rate of Acute Kidney Injury [ Time Frame: From date of admission until the date of discharge or death from any cause, up to 60 days ]the incidence of Acute Kidney Injury","Rate of Death [ Time Frame: From date of admission until the date of death from any cause, up to 60 days ]death from any cause in the hospital
the length of hospital stay [ Time Frame: From date of admission until the date of discharge or death from any cause, up to 60 days ]days from admission to discharge or death the length of hospital stay [ Time Frame: From date of admission until the date of discharge or death from any cause, up to 60 days ]days from admission to discharge or death",287
61,Not yet recruiting,"Phase 2
Phase 3",All,"18 Years and older   (Adult, Older Adult)",NCT04310865,changes in the ratio of PaO2 to FiO2 from baseline [ Time Frame: Day 10 ],"PaO2 [ Time Frame: up to 30 days ]
blood oxygen saturation (SpO2) [ Time Frame: up to 30 days ]
clinical status rating on the 7-point ordinal scale [ Time Frame: up to 30 days ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Time to Clinical Improvement (TTCI) [ Time Frame: up to 30 days ]TTCI is defined as the time (in days) from initiation of study treatment (Yinhu Qingwen Granula or its low-dose granula) until a decline of two categories from status at randomisation on the 7-point ordinal scale of clinical status which ranges from 0 (death) to 6 (Not hospitalized, no limitations on activities).
Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use [ Time Frame: up to 30 days ]
Duration (hours) of invasive mechanical ventilation use [ Time Frame: up to 30 days ]
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use [ Time Frame: up to 30 days ]
Duration (days) of Oxygen use [ Time Frame: up to 30 days ]
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] blood oxygen saturation (SpO2) [ Time Frame: up to 30 days ]
clinical status rating on the 7-point ordinal scale [ Time Frame: up to 30 days ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Time to Clinical Improvement (TTCI) [ Time Frame: up to 30 days ]TTCI is defined as the time (in days) from initiation of study treatment (Yinhu Qingwen Granula or its low-dose granula) until a decline of two categories from status at randomisation on the 7-point ordinal scale of clinical status which ranges from 0 (death) to 6 (Not hospitalized, no limitations on activities).
Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use [ Time Frame: up to 30 days ]
Duration (hours) of invasive mechanical ventilation use [ Time Frame: up to 30 days ]
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use [ Time Frame: up to 30 days ]
Duration (days) of Oxygen use [ Time Frame: up to 30 days ]
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] clinical status rating on the 7-point ordinal scale [ Time Frame: up to 30 days ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Time to Clinical Improvement (TTCI) [ Time Frame: up to 30 days ]TTCI is defined as the time (in days) from initiation of study treatment (Yinhu Qingwen Granula or its low-dose granula) until a decline of two categories from status at randomisation on the 7-point ordinal scale of clinical status which ranges from 0 (death) to 6 (Not hospitalized, no limitations on activities).
Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use [ Time Frame: up to 30 days ]
Duration (hours) of invasive mechanical ventilation use [ Time Frame: up to 30 days ]
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use [ Time Frame: up to 30 days ]
Duration (days) of Oxygen use [ Time Frame: up to 30 days ]
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] Time to Clinical Improvement (TTCI) [ Time Frame: up to 30 days ]TTCI is defined as the time (in days) from initiation of study treatment (Yinhu Qingwen Granula or its low-dose granula) until a decline of two categories from status at randomisation on the 7-point ordinal scale of clinical status which ranges from 0 (death) to 6 (Not hospitalized, no limitations on activities).
Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use [ Time Frame: up to 30 days ]
Duration (hours) of invasive mechanical ventilation use [ Time Frame: up to 30 days ]
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use [ Time Frame: up to 30 days ]
Duration (days) of Oxygen use [ Time Frame: up to 30 days ]
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] Duration (hours) of non-invasive mechanical ventilation or high-flow nasal catheter oxygen inhalation use [ Time Frame: up to 30 days ]
Duration (hours) of invasive mechanical ventilation use [ Time Frame: up to 30 days ]
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use [ Time Frame: up to 30 days ]
Duration (days) of Oxygen use [ Time Frame: up to 30 days ]
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] Duration (hours) of invasive mechanical ventilation use [ Time Frame: up to 30 days ]
Duration (hours) of extracorporeal membrane oxygenation (ECMO) use [ Time Frame: up to 30 days ]
Duration (days) of Oxygen use [ Time Frame: up to 30 days ]
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] Duration (hours) of extracorporeal membrane oxygenation (ECMO) use [ Time Frame: up to 30 days ]
Duration (days) of Oxygen use [ Time Frame: up to 30 days ]
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] Duration (days) of Oxygen use [ Time Frame: up to 30 days ]
The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] The proportion of the patients reporting 2019-nCoV RT-PCR negativity at Day 10 after treatment [ Time Frame: Day 10 ]
The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] The counts/percentage of Lymphocyte [ Time Frame: up to 30 days ]
Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] Time to hospital discharge with clinical recovery from the randomisation [ Time Frame: up to 30 days ]
The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] The incidence of critical status conversion in 30 days [ Time Frame: up to 30 days ]Critical status is defined as: 1) respiratory failure with the need of invasive mechanical ventilation; or 2) shock; or 3) other system organ failure with ICU admission.
All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] All-cause mortality within 30 days [ Time Frame: up to 30 days ]
Frequency of severe adverse drug events [ Time Frame: up to 30 days ] Frequency of severe adverse drug events [ Time Frame: up to 30 days ]",116
62,Recruiting,Not Applicable,All,"5 Years and older   (Child, Adult, Older Adult)",NCT04325646,Presence of specific anti-SARS-CoV-2 antibodies in the different study groups. [ Time Frame: One year ]Description of the serological status of individuals by different detection tests,Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies [ Time Frame: One year ]Proportion of asymptomatic subjects into seropositive population,1000
63,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04268537,lung injury score [ Time Frame: 7 days ]proportion of lung injury score decreased 1 or more points,"absolute lymphocyte counts [ Time Frame: 7, 14 and 28 days ]lymphocyte counts at day 7, 14 and 28 after randimization
serum level of CRP, PCT and IL-6 [ Time Frame: 3, 7 and 14 days ]serum level of CRP, PCT and IL-6 at day 3,7 and 14 after randimization
SOFA score [ Time Frame: 7 days ]SOFA score at Day 7, with scores range from 0 to 24 and higher score means worse outcome
all cause mortality rate [ Time Frame: 28 days ]died at day 28
ventilation free days [ Time Frame: 28 days ]
ICU free days [ Time Frame: up to 28 days ] serum level of CRP, PCT and IL-6 [ Time Frame: 3, 7 and 14 days ]serum level of CRP, PCT and IL-6 at day 3,7 and 14 after randimization
SOFA score [ Time Frame: 7 days ]SOFA score at Day 7, with scores range from 0 to 24 and higher score means worse outcome
all cause mortality rate [ Time Frame: 28 days ]died at day 28
ventilation free days [ Time Frame: 28 days ]
ICU free days [ Time Frame: up to 28 days ] SOFA score [ Time Frame: 7 days ]SOFA score at Day 7, with scores range from 0 to 24 and higher score means worse outcome
all cause mortality rate [ Time Frame: 28 days ]died at day 28
ventilation free days [ Time Frame: 28 days ]
ICU free days [ Time Frame: up to 28 days ] all cause mortality rate [ Time Frame: 28 days ]died at day 28
ventilation free days [ Time Frame: 28 days ]
ICU free days [ Time Frame: up to 28 days ] ventilation free days [ Time Frame: 28 days ]
ICU free days [ Time Frame: up to 28 days ] ICU free days [ Time Frame: up to 28 days ]",120
64,Not yet recruiting,Not Applicable,All,"16 Years and older   (Child, Adult, Older Adult)",NCT04303507,"Number of symptomatic COVID-19 infections [ Time Frame: Approximately 100 days ]Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups
Symptoms severity of COVID-19 [ Time Frame: Approximately 100 days ]Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score. Symptoms severity of COVID-19 [ Time Frame: Approximately 100 days ]Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.","Number of asymptomatic cases of COVID-19 [ Time Frame: Approximately 100 days ]Number of asymptomatic cases of COVID-19 will be determined by comparing acute and convalescent serology in the two groups.
Number of symptomatic acute respiratory illnesses [ Time Frame: Approximately 100 days ]Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Severity of symptomatic acute respiratory illnesses [ Time Frame: Approximately 100 days ]Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups. Number of symptomatic acute respiratory illnesses [ Time Frame: Approximately 100 days ]Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Severity of symptomatic acute respiratory illnesses [ Time Frame: Approximately 100 days ]Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups. Severity of symptomatic acute respiratory illnesses [ Time Frame: Approximately 100 days ]Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.",40000
65,Recruiting,,All,"16 Years and older   (Child, Adult, Older Adult)",NCT04320017,"Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay [ Time Frame: ECG and concomitant troponine at day 1 after admission and twice a week after admission and until patient is discharged, transthoracic echocardiography at day 1 and day 7, t ]Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography","Description of cardiovascular outcomes in the cohort [ Time Frame: During hospital admission ]Cardio-vascular events including but not limited to: myocardial infarction or stenosis, stroke, pulmonary embolism, deep vein thrombosis, ventricular dysfunctio, conduction disorders and sudden death
Prognosis role of baseline cardio-vascular caracteristics on patients survival [ Time Frame: 1st day of admission ]Biological biomarkers including but not limited to: baseline troponine T, D-dimers, NT-proBNP, creatinine phosphokinase, creatininemia, ionogram, renine-angiotensin aldosterone system profiling, glycemia (fasting), HbA1c, steroid profiling, lipid profiling
Prediction of cardio-vascular events with baseline characteristics [ Time Frame: Baseline on first day of admission ]
Characterization of inflammation on cardio-vascular outcomes [ Time Frame: Baseline and every 2 days ]Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6 Prognosis role of baseline cardio-vascular caracteristics on patients survival [ Time Frame: 1st day of admission ]Biological biomarkers including but not limited to: baseline troponine T, D-dimers, NT-proBNP, creatinine phosphokinase, creatininemia, ionogram, renine-angiotensin aldosterone system profiling, glycemia (fasting), HbA1c, steroid profiling, lipid profiling
Prediction of cardio-vascular events with baseline characteristics [ Time Frame: Baseline on first day of admission ]
Characterization of inflammation on cardio-vascular outcomes [ Time Frame: Baseline and every 2 days ]Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6 Prediction of cardio-vascular events with baseline characteristics [ Time Frame: Baseline on first day of admission ]
Characterization of inflammation on cardio-vascular outcomes [ Time Frame: Baseline and every 2 days ]Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6 Characterization of inflammation on cardio-vascular outcomes [ Time Frame: Baseline and every 2 days ]Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6",500
66,Recruiting,Not Applicable,All,"Child, Adult, Older Adult",NCT04304690,Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff [ Time Frame: 3 months ]Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.,"Identification of risk factors for seroconversion [ Time Frame: 3 months ]""Age, gender, type of staff, medical staff: resident, Clinic Chief or University Hospital Assistant (CCA / AHU), Associate Practitioner (PA), Contractual Hospital Practitioner (PHC), Hospital Practitioner (PH), Lecturer-Hospital Practitioner (MCU-PH) , University Professor-Hospital Practitioner (PUPH) non-medical staff: nursing assistants (AS), nurses (IDE), physiotherapist, managers, others, Seniority in the profession (number of years) Service tenure (years), Night, day, day or mixed work, Type of service: emergency department, infectious disease service, ICU), Type of hospital (firstline reference hospital or not), Documented contact with a confirmed patient.""
Quantify the proportion of asymptomatic infections among staff who have seroconverted [ Time Frame: 3 months ]""Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain) reported via the weekly self-monitoring booklet.
The asymptomatic characteristics will be determined by an adjudication committee, in the light of the weekly self-monitoring notebooks, without knowing the results of the serologies.""
"" Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "" [ Time Frame: 3 months ]""Description of symptomatic infections

Clinical manifestations associated with seroconversion.
On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "" Quantify the proportion of asymptomatic infections among staff who have seroconverted [ Time Frame: 3 months ]""Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain) reported via the weekly self-monitoring booklet.
The asymptomatic characteristics will be determined by an adjudication committee, in the light of the weekly self-monitoring notebooks, without knowing the results of the serologies.""
"" Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "" [ Time Frame: 3 months ]""Description of symptomatic infections

Clinical manifestations associated with seroconversion.
On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "" "" Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "" [ Time Frame: 3 months ]""Description of symptomatic infections

Clinical manifestations associated with seroconversion.
On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "" Clinical manifestations associated with seroconversion. On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) """,1000
67,Enrolling by invitation,Not Applicable,All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04273763,"Time to clinical recovery after treatment [ Time Frame: within 14 days from the start of medication ]Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
Rate of aggravation [ Time Frame: within 14 days from the start of medication ]Aggravation was defined as(one of them): respiratory distress, RR ≥ 30 times / min; SpO2 ≤ 93% in resting state; arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg Rate of aggravation [ Time Frame: within 14 days from the start of medication ]Aggravation was defined as(one of them): respiratory distress, RR ≥ 30 times / min; SpO2 ≤ 93% in resting state; arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg","Clinical remission rate [ Time Frame: within 14 days from the start of medication ]Clinical remission was defined as (one of them): sustained (more than 48 hours) alleviation of illness based on symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) all being absent and no evidence for progression.
Dynamic changes of oxygenation index [ Time Frame: within 14 days from the start of medication ]oxygenation index
Time to cure [ Time Frame: within 14 days from the start of medication ]time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
rate to cure [ Time Frame: within 14 days from the start of medication ]proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Time to defervescence [ Time Frame: within 14 days from the start of medication ]defervescence is defined as below 37 Celcius degrees（ear temperature）
Time to cough remission [ Time Frame: within 14 days from the start of medication ]
Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Dynamic changes of oxygenation index [ Time Frame: within 14 days from the start of medication ]oxygenation index
Time to cure [ Time Frame: within 14 days from the start of medication ]time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
rate to cure [ Time Frame: within 14 days from the start of medication ]proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Time to defervescence [ Time Frame: within 14 days from the start of medication ]defervescence is defined as below 37 Celcius degrees（ear temperature）
Time to cough remission [ Time Frame: within 14 days from the start of medication ]
Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Time to cure [ Time Frame: within 14 days from the start of medication ]time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
rate to cure [ Time Frame: within 14 days from the start of medication ]proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Time to defervescence [ Time Frame: within 14 days from the start of medication ]defervescence is defined as below 37 Celcius degrees（ear temperature）
Time to cough remission [ Time Frame: within 14 days from the start of medication ]
Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] rate to cure [ Time Frame: within 14 days from the start of medication ]proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Time to defervescence [ Time Frame: within 14 days from the start of medication ]defervescence is defined as below 37 Celcius degrees（ear temperature）
Time to cough remission [ Time Frame: within 14 days from the start of medication ]
Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Time to defervescence [ Time Frame: within 14 days from the start of medication ]defervescence is defined as below 37 Celcius degrees（ear temperature）
Time to cough remission [ Time Frame: within 14 days from the start of medication ]
Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Time to cough remission [ Time Frame: within 14 days from the start of medication ]
Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ] 28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ]",60
68,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04252664,"Time to Clinical recoveryTime to Clinical Recovery (TTCR) [ Time Frame: up to 28 days ]TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours.
Normalisation and alleviation criteria:

Fever - ≤36.9°C or -axilla, ≤37.2 °C oral,
Respiratory rate - ≤24/minute on room air,
Oxygen saturation - >94% on room air,
Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent. Fever - ≤36.9°C or -axilla, ≤37.2 °C oral, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.","Fever - ≤36.9°C or -axilla, ≤37.2 °C oral, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.",308
69,Recruiting,Phase 1,All,"18 Years to 70 Years   (Adult, Older Adult)",NCT04252118,"Size of lesion area by chest radiograph or CT [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21，Day 28 ]Evaluation of Pneumonia Improvement
Side effects in the MSCs treatment group [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Side effects in the MSCs treatment group [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","Improvement of Clinical symptoms including duration of fever and respiratory [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28 ]Evaluation of Pneumonia Improvement
Time of nucleic acid turning negative [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Marker for 2019-nCoV
Rate of mortality within 28-days [ Time Frame: Day 28 ]Marker for efficacy of treatment
CD4+ and CD8+ T celll count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Marker of Immunological function
Alanine aminotransferase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function
C-reactive protein [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of Infection
Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function Time of nucleic acid turning negative [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Marker for 2019-nCoV
Rate of mortality within 28-days [ Time Frame: Day 28 ]Marker for efficacy of treatment
CD4+ and CD8+ T celll count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Marker of Immunological function
Alanine aminotransferase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function
C-reactive protein [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of Infection
Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function Rate of mortality within 28-days [ Time Frame: Day 28 ]Marker for efficacy of treatment
CD4+ and CD8+ T celll count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Marker of Immunological function
Alanine aminotransferase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function
C-reactive protein [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of Infection
Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function CD4+ and CD8+ T celll count [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Marker of Immunological function
Alanine aminotransferase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function
C-reactive protein [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of Infection
Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function Alanine aminotransferase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function
C-reactive protein [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of Infection
Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function C-reactive protein [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of Infection
Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function Creatine kinase [ Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180 ]Markers of organ function",20
70,Not yet recruiting,"Phase 2
Phase 3",All,"18 Years and older   (Adult, Older Adult)",NCT04261426,"Clinical improvement based on the 7-point scale [ Time Frame: 28 days after randomization ]A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Lower Murray lung injury score [ Time Frame: 7 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Lower Murray lung injury score [ Time Frame: 14 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition. Lower Murray lung injury score [ Time Frame: 7 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Lower Murray lung injury score [ Time Frame: 14 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition. Lower Murray lung injury score [ Time Frame: 14 days after randomization ]Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.","28-day mortality [ Time Frame: Measured from Day 0 through Day 28 ]Number of deaths during study follow-up
Duration of mechanical ventilation [ Time Frame: Measured from Day 0 through Day 28 ]Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Duration of hospitalization [ Time Frame: Measured from Day 0 through Day 28 ]Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Proportion of patients with negative RT-PCR results [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Proportion of patients in each category of the 7-point scale [ Time Frame: 7,14 and 28 days after randomization ]Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Proportion of patients with normalized inflammation factors [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with different inflammation factors in normalization range.
Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Adverse Drug Events
Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events Duration of mechanical ventilation [ Time Frame: Measured from Day 0 through Day 28 ]Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Duration of hospitalization [ Time Frame: Measured from Day 0 through Day 28 ]Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Proportion of patients with negative RT-PCR results [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Proportion of patients in each category of the 7-point scale [ Time Frame: 7,14 and 28 days after randomization ]Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Proportion of patients with normalized inflammation factors [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with different inflammation factors in normalization range.
Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Adverse Drug Events
Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events Duration of hospitalization [ Time Frame: Measured from Day 0 through Day 28 ]Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Proportion of patients with negative RT-PCR results [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Proportion of patients in each category of the 7-point scale [ Time Frame: 7,14 and 28 days after randomization ]Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Proportion of patients with normalized inflammation factors [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with different inflammation factors in normalization range.
Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Adverse Drug Events
Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events Proportion of patients with negative RT-PCR results [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Proportion of patients in each category of the 7-point scale [ Time Frame: 7,14 and 28 days after randomization ]Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Proportion of patients with normalized inflammation factors [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with different inflammation factors in normalization range.
Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Adverse Drug Events
Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events Proportion of patients in each category of the 7-point scale [ Time Frame: 7,14 and 28 days after randomization ]Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Proportion of patients with normalized inflammation factors [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with different inflammation factors in normalization range.
Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Adverse Drug Events
Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events Proportion of patients with normalized inflammation factors [ Time Frame: 7 and 14 days after randomization ]Proportion of patients with different inflammation factors in normalization range.
Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Adverse Drug Events
Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events Frequency of Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Adverse Drug Events
Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events Frequency of Serious Adverse Drug Events [ Time Frame: Measured from Day 0 through Day 28 ]Frequency of Serious Adverse Drug Events",80
71,Recruiting,,All,70 Years and older   (Older Adult),NCT04321265,Survival [ Time Frame: up to 30 days ],Fragilty [ Time Frame: pre-admission ]Fragilty will be measured by using the Clinical frailty scale (CFS) a global clinical measure of fitness and frailty in elderly people (1=very fit to 9= terminally ill),4000
72,Recruiting,Phase 4,All,"18 Years and older   (Adult, Older Adult)",NCT04255017,"Rate of disease remission [ Time Frame: two weeks ]A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2>300mmHg (1mmHg=0.133Kpa);
Time for lung recovery [ Time Frame: two weeks ]Compare the average time of lung imaging recovery after 2 weeks of treatment in each group. Time for lung recovery [ Time Frame: two weeks ]Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.","Rate of no fever [ Time Frame: two weeks ]
Rate of respiratory symptom remission [ Time Frame: two weeks ]
Rate of lung imaging recovery [ Time Frame: two weeks ]
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery [ Time Frame: two weeks ]
Rate of undetectable viral RNA [ Time Frame: two weeks ] Rate of respiratory symptom remission [ Time Frame: two weeks ]
Rate of lung imaging recovery [ Time Frame: two weeks ]
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery [ Time Frame: two weeks ]
Rate of undetectable viral RNA [ Time Frame: two weeks ] Rate of lung imaging recovery [ Time Frame: two weeks ]
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery [ Time Frame: two weeks ]
Rate of undetectable viral RNA [ Time Frame: two weeks ] Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery [ Time Frame: two weeks ]
Rate of undetectable viral RNA [ Time Frame: two weeks ] Rate of undetectable viral RNA [ Time Frame: two weeks ]",400
73,Recruiting,Phase 4,All,"18 Years and older   (Adult, Older Adult)",NCT04254874,"Rate of disease remission [ Time Frame: two weeks ]A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2> 300mmHg (1mmHg=0.133Kpa);
Time for lung recovery [ Time Frame: two weeks ]Compare the average time of lung imaging recovery after 2 weeks of treatment in each group. Time for lung recovery [ Time Frame: two weeks ]Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.","Rate of no fever [ Time Frame: two weeks ]
Rate of respiratory symptom remission [ Time Frame: two weeks ]
Rate of lung imaging recovery [ Time Frame: two weeks ]
Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery [ Time Frame: two weeks ]
Rate of undetectable viral RNA [ Time Frame: two weeks ] Rate of respiratory symptom remission [ Time Frame: two weeks ]
Rate of lung imaging recovery [ Time Frame: two weeks ]
Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery [ Time Frame: two weeks ]
Rate of undetectable viral RNA [ Time Frame: two weeks ] Rate of lung imaging recovery [ Time Frame: two weeks ]
Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery [ Time Frame: two weeks ]
Rate of undetectable viral RNA [ Time Frame: two weeks ] Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery [ Time Frame: two weeks ]
Rate of undetectable viral RNA [ Time Frame: two weeks ] Rate of undetectable viral RNA [ Time Frame: two weeks ]",100
74,Recruiting,,All,"18 Years to 99 Years   (Adult, Older Adult)",NCT04316949,"Respiratory failure [ Time Frame: 14 days ]Composite of ICU admission or SpO2<92% with 100% FiO2 of oxygen treatment (reservoir mask or CPAP or NIV), respiratory rate >25 bpm, respiratory distress",Occurence of bacterial superinfection [ Time Frame: 14 days ]Incidence of bacterial superinfection among ventilated patients with SARS-CoV-2 pneumonia,350
75,Available,,All,"18 Years and older   (Adult, Older Adult)",NCT04323761,"Drug: Remdesivir
Intravenous infusion administered over a 30 to 120 minute period
Other Name: GS-5734™","Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age) Hospitalized with confirmed SARS-CoV2 by polymerase chain reaction (PCR) or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) with PCR pending Requiring invasive mechanical ventilation (e.g., via endotracheal intubation or tracheostomy) Adequate renal function with estimated glomerular filtration rate (eGRF) ≥ 30 ml/min by local laboratory measure Alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (ULN) by local laboratory measure",
76,Recruiting,Phase 3,All,18 Years to 55 Years   (Adult),NCT04261270,"Rate of comprehensive adverse outcome [ Time Frame: 14 days ]The definition of comprehensive adverse outcome is as follows:

SPO2≤93% without oxygen inhalation;
PaO2/FiO2≤300mmHg;
RR≥30 bpm without oxygen inhalation. SPO2≤93% without oxygen inhalation; PaO2/FiO2≤300mmHg; RR≥30 bpm without oxygen inhalation.",SPO2≤93% without oxygen inhalation; PaO2/FiO2≤300mmHg; RR≥30 bpm without oxygen inhalation.,60
77,Recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04320511,"Predictive association between CT-V, PBM score and disease progression [ Time Frame: 30 days ]Disease progression will be characterized as requiring mechanical ventilator support, non-invasive positive pressure ventilation, high flow nasal cannula or mortality within 30 days.CT-V and PBM scores will be calculated at a voxel level from inhalation-exhalation CT scan. Several CT-V pulmonary function metrics, including the volume of identified ""cold spots"" (areas with decreased ventilation and perfusion), total ventilation and perfusion and radiographic fibrosis score will be calculated to assess regional ventilation/perfusion and compared to disease progression. The number of participants with correlation between these factors will be reported.",Adults >18 years of age Informed consent A confirmed diagnosis of SARS-CoV-2 with mild to moderate disease defined as oxygen > 90% on room air on or supplemental oxygen not more than 6L Concomitant medications for the treatment are allowed,25
78,Recruiting,Phase 4,All,"18 Years and older   (Adult, Older Adult)",NCT04263402,"Rate of disease remission [ Time Frame: day 7 ]For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2>93% or PaO2/FiO2 >300mmHg.
Rate and time of entering the critical stage [ Time Frame: day 7 ]the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment. Rate and time of entering the critical stage [ Time Frame: day 7 ]the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.","Rate of normal tempreture [ Time Frame: day 7 ]Rate of patients without fever at day 7
Rate of respiratory symptom remission [ Time Frame: day 7 ]Rate of patients with respiratory symptom remission at day 7
Rate of lung imaging recovery [ Time Frame: day 7 ]Rate of patients with lung imaging recovery at day 7
Rate of laboratory indicator recovery [ Time Frame: day 7 ]Rate of patients with laboratory indicator recovery at day 7
Rate of undetectable viral RNA [ Time Frame: day 7 ]Rate of patients withundetectable viral RNA at day 7 Rate of respiratory symptom remission [ Time Frame: day 7 ]Rate of patients with respiratory symptom remission at day 7
Rate of lung imaging recovery [ Time Frame: day 7 ]Rate of patients with lung imaging recovery at day 7
Rate of laboratory indicator recovery [ Time Frame: day 7 ]Rate of patients with laboratory indicator recovery at day 7
Rate of undetectable viral RNA [ Time Frame: day 7 ]Rate of patients withundetectable viral RNA at day 7 Rate of lung imaging recovery [ Time Frame: day 7 ]Rate of patients with lung imaging recovery at day 7
Rate of laboratory indicator recovery [ Time Frame: day 7 ]Rate of patients with laboratory indicator recovery at day 7
Rate of undetectable viral RNA [ Time Frame: day 7 ]Rate of patients withundetectable viral RNA at day 7 Rate of laboratory indicator recovery [ Time Frame: day 7 ]Rate of patients with laboratory indicator recovery at day 7
Rate of undetectable viral RNA [ Time Frame: day 7 ]Rate of patients withundetectable viral RNA at day 7 Rate of undetectable viral RNA [ Time Frame: day 7 ]Rate of patients withundetectable viral RNA at day 7",100
79,Recruiting,Phase 2,All,"18 Years to 65 Years   (Adult, Older Adult)",NCT04279197,"High-resolution computed tomography (HRCT) score [ Time Frame: Week 24 ]Evaluation of Pulmonary fibrosis Improvement. HRCT images are graded from 1 to 6, higher scores mean a worse outcome.
Lung function including FVC, FVC as a percentage of projected value and DLco [ Time Frame: Week 24 ]Evaluation of Lung Function Improvement Lung function including FVC, FVC as a percentage of projected value and DLco [ Time Frame: Week 24 ]Evaluation of Lung Function Improvement","Times of acute exacerbation [ Time Frame: Week 24 ]Times of acute exacerbations during treatment
Six-minute walk distance [ Time Frame: Week 24 ]Measured by a 6-minute walking test
Dyspnea Scores [ Time Frame: Week 24 ]Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.
Composite physiological index [ Time Frame: Week 24 ]Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula. Six-minute walk distance [ Time Frame: Week 24 ]Measured by a 6-minute walking test
Dyspnea Scores [ Time Frame: Week 24 ]Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.
Composite physiological index [ Time Frame: Week 24 ]Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula. Dyspnea Scores [ Time Frame: Week 24 ]Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.
Composite physiological index [ Time Frame: Week 24 ]Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula. Composite physiological index [ Time Frame: Week 24 ]Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula.",136
80,Completed,,All,"Child, Adult, Older Adult",NCT04284046,7-day mortality [ Time Frame: 7-day ],all patients suspected of 2019 novel coronavirus infection.,39
81,Not yet recruiting,Not Applicable,All,"60 Years and older   (Adult, Older Adult)",NCT04321928,"Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases [ Time Frame: 12 months ]The primary endpoint will be the composite of the rate of the followings in COVID-19 positive cases (verified by an accredited laboratory): the number of pariticipants with ICU (intensive care unit) admission; 48 hours of hospitalisation and/or death.
48 hours of hospitalisation for the following reasons: (I) arrhythmia (causing hemodynamic instability and requiring continuous monitoring and/or cardiac support, as indicated by mean arterial pressure <65 mm Hg, and/or serum lactate >2 mmol/L) and/or (II) Acute Respiratory Distress Syndrome (ARDS): severe hypoxaemic respiratory failure indicated by a Partial Pressure of Oxygen (PaO2)/Fraction of inspired oxygen (FiO2) <300 mmHg according to the Berlin definition and/or (III) circulatory shock (the requirement of continuous vasopressor support to maintain mean arterial pressure <65 mmHg and/or serum lactate >2 mmol/L)","The number of general practitioner visits [ Time Frame: 12 months ]The number of participants, who required general practitioner visit assessed by the investigator.
The number of emergency, hospital admission and intensive care admission [ Time Frame: 12 months ]The number of participants, who required the admission to each type of level of care assessed by the investigator.
Length of hospitalization and intensive care unit stay [ Time Frame: 12 months ]The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.
Organ dysfunction [ Time Frame: 12 months ]The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU.
Lifestyle changes [ Time Frame: 12 months ]The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire.
The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress.
One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.
The cost of care [ Time Frame: 12 months ]The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed. The number of emergency, hospital admission and intensive care admission [ Time Frame: 12 months ]The number of participants, who required the admission to each type of level of care assessed by the investigator.
Length of hospitalization and intensive care unit stay [ Time Frame: 12 months ]The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.
Organ dysfunction [ Time Frame: 12 months ]The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU.
Lifestyle changes [ Time Frame: 12 months ]The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire.
The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress.
One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.
The cost of care [ Time Frame: 12 months ]The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed. Length of hospitalization and intensive care unit stay [ Time Frame: 12 months ]The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.
Organ dysfunction [ Time Frame: 12 months ]The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU.
Lifestyle changes [ Time Frame: 12 months ]The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire.
The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress.
One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.
The cost of care [ Time Frame: 12 months ]The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed. Organ dysfunction [ Time Frame: 12 months ]The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU.
Lifestyle changes [ Time Frame: 12 months ]The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire.
The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress.
One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.
The cost of care [ Time Frame: 12 months ]The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed. Lifestyle changes [ Time Frame: 12 months ]The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire.
The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress.
One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.
The cost of care [ Time Frame: 12 months ]The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed. The cost of care [ Time Frame: 12 months ]The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed.",7576
82,Recruiting,Phase 1,All,18 Years to 60 Years   (Adult),NCT04313127,Safety indexes of adverse reactions [ Time Frame: 0-7 days post-vaccination ]Occurrence of adverse reactions post-vaccination,"Safety indexes of adverse events [ Time Frame: 0-28 days post-vaccination ]Occurrence of adverse events post-vaccination
Safety indexes of SAE [ Time Frame: 0-28 days, within 6 mouths post-vaccination ]Occurrence of serious adverse events post-vaccination
Safety indexes of lab measures [ Time Frame: pre-vaccination, day 7 post-vaccination ]Occurrence of abnormal changes of laboratory safety examinations
Immunogencity indexes of GMT(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMT(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of seropositivity rates(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Safety indexes of SAE [ Time Frame: 0-28 days, within 6 mouths post-vaccination ]Occurrence of serious adverse events post-vaccination
Safety indexes of lab measures [ Time Frame: pre-vaccination, day 7 post-vaccination ]Occurrence of abnormal changes of laboratory safety examinations
Immunogencity indexes of GMT(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMT(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of seropositivity rates(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Safety indexes of lab measures [ Time Frame: pre-vaccination, day 7 post-vaccination ]Occurrence of abnormal changes of laboratory safety examinations
Immunogencity indexes of GMT(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMT(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of seropositivity rates(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of GMT(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMT(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of seropositivity rates(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of GMT(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of seropositivity rates(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of seropositivity rates(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of GMI(ELISA) [ Time Frame: day14,28，month 3,6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of GMI(pseudoviral neutralization test method) [ Time Frame: day14,28，month 6 post-vaccination ]Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of GMC(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of GMI(Ad5 vector) [ Time Frame: day、14,28，month3,6 post-vaccination ]Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses Immunogencity indexes of cellular immune [ Time Frame: day 14, 28,month 6 post-vaccination ]specific cellular immune responses",108
83,Not yet recruiting,Not Applicable,All,"Child, Adult, Older Adult",NCT04319445,"Helpfulness of the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.
Platform effectiveness [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes. Platform effectiveness [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.","Change in Anxiety Level [ Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes worse outcomes.
Change in Stress Level [ Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes worse outcomes.
Value of the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.
Satisfaction with the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.
Percentage of participants that showed interest in a future session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants that would recommend this session to a family member [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants by session frequency preference [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered Change in Stress Level [ Time Frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes worse outcomes.
Value of the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.
Satisfaction with the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.
Percentage of participants that showed interest in a future session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants that would recommend this session to a family member [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants by session frequency preference [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered Value of the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.
Satisfaction with the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.
Percentage of participants that showed interest in a future session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants that would recommend this session to a family member [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants by session frequency preference [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered Satisfaction with the session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Total scale 1-5. Higher scores denotes better outcomes.
Percentage of participants that showed interest in a future session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants that would recommend this session to a family member [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants by session frequency preference [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered Percentage of participants that showed interest in a future session [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants that would recommend this session to a family member [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants by session frequency preference [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered Percentage of participants that would recommend this session to a family member [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]
Percentage of participants by session frequency preference [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered Percentage of participants by session frequency preference [ Time Frame: Post-Intervention (upon completion of session up to 15 minutes) ]Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered",200
84,Recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04320472,prevalence [ Time Frame: at ICU admission ]ratio of patients with acute encephalopathy among the total of patients with SARS-Cov-2 infection at ICU admission,"Favorable outcome [ Time Frame: 3 months ]A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined patients charts review and/or general practitioner interview conducted by an independent assessor. The GOS score : [1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability]",250
85,Not yet recruiting,Not Applicable,All,"18 Years and older   (Adult, Older Adult)",NCT04264858,"Time to Clinical Improvement (TTCI) [ Time Frame: up to 28 days ]TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death).
Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge.
Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.","Clinical status assessed by the ordinal scale [ Time Frame: up to 28 days ]on days 7, 14, 21, and 28
The differences in oxygen intake methods [ Time Frame: up to 28 days ]1. No need for supplemental oxygenation; 2. nasal cathete oxygen inhalation；3. Mask oxygen inhalation；4. Noninvasive ventilator oxygen supply；5. Invasive ventilator oxygen supply.
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] [ Time Frame: up to 28 days ]The detection frequency could be increased according to clinician's decision
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] [ Time Frame: up to 28 days ]
Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]The antibody titer is detected on days 3 and 28
Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] The differences in oxygen intake methods [ Time Frame: up to 28 days ]1. No need for supplemental oxygenation; 2. nasal cathete oxygen inhalation；3. Mask oxygen inhalation；4. Noninvasive ventilator oxygen supply；5. Invasive ventilator oxygen supply.
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] [ Time Frame: up to 28 days ]The detection frequency could be increased according to clinician's decision
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] [ Time Frame: up to 28 days ]
Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]The antibody titer is detected on days 3 and 28
Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] [ Time Frame: up to 28 days ]The detection frequency could be increased according to clinician's decision
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] [ Time Frame: up to 28 days ]
Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]The antibody titer is detected on days 3 and 28
Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] [ Time Frame: up to 28 days ]The detection frequency could be increased according to clinician's decision
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] [ Time Frame: up to 28 days ]
Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]The antibody titer is detected on days 3 and 28
Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] [ Time Frame: up to 28 days ]The detection frequency could be increased according to clinician's decision
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] [ Time Frame: up to 28 days ]
Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]The antibody titer is detected on days 3 and 28
Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days] [ Time Frame: up to 28 days ]The detection frequency could be increased according to clinician's decision
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] [ Time Frame: up to 28 days ]
Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]The antibody titer is detected on days 3 and 28
Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days] [ Time Frame: up to 28 days ]
Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]The antibody titer is detected on days 3 and 28
Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] Dynamic changes of 2019-nCoV antibody titer in blood [ Time Frame: up to 28 days ]The antibody titer is detected on days 3 and 28
Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] Length of hospital stay (days) [ Time Frame: up to 28 days ]
All cause mortality [ Time Frame: up to 28 days ] All cause mortality [ Time Frame: up to 28 days ]",10
86,Not yet recruiting,,All,"16 Years to 100 Years   (Child, Adult, Older Adult)",NCT04311398,"Long incubation period (average 5-7 days, up to 28 days), and the incubation period is contagious Strong transmissibility, virus can be transmitted through aerosol Difficulty distinguishing infected patients from other pathogenic infections High negative rate of nucleic acid detection in upper respiratory tract samples of infected patients, which increases the difficulty of differential diagnosis of infection with other pathogens The existing RT-PCR nucleic acid detection kits for SARS-CoV-2 has two major problems. First, the procedure is not automated leading to higher requirements for personnel operation level and environment sterilize. What's more the kits are SARS-CoV-2 only. Once the test result is negative, it cannot help diagnose the exact pathogen in one time of experiment.",Sensitivity， spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform [ Time Frame: 3 months ],100
87,Recruiting,Not Applicable,All,"18 Years to 65 Years   (Adult, Older Adult)",NCT04310228,"Clinical cure rate [ Time Frame: 3 months ]Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.","Viral nucleic acid test negative conversion rate and days from positive to negative [ Time Frame: 14 days after taking medicine ]
Duration of fever [ Time Frame: 14 days after taking medicine ]
Lung imaging improvement time [ Time Frame: 14 days after taking medicine ]
Mortality rate because of Corona Virus Disease 2019 [ Time Frame: 3 months ]
Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs [ Time Frame: 3 months ]
Mean in-hospital time [ Time Frame: 3 months ] Duration of fever [ Time Frame: 14 days after taking medicine ]
Lung imaging improvement time [ Time Frame: 14 days after taking medicine ]
Mortality rate because of Corona Virus Disease 2019 [ Time Frame: 3 months ]
Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs [ Time Frame: 3 months ]
Mean in-hospital time [ Time Frame: 3 months ] Lung imaging improvement time [ Time Frame: 14 days after taking medicine ]
Mortality rate because of Corona Virus Disease 2019 [ Time Frame: 3 months ]
Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs [ Time Frame: 3 months ]
Mean in-hospital time [ Time Frame: 3 months ] Mortality rate because of Corona Virus Disease 2019 [ Time Frame: 3 months ]
Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs [ Time Frame: 3 months ]
Mean in-hospital time [ Time Frame: 3 months ] Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs [ Time Frame: 3 months ]
Mean in-hospital time [ Time Frame: 3 months ] Mean in-hospital time [ Time Frame: 3 months ]",150
88,Not yet recruiting,Early Phase 1,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04302519,Disppear time of ground-glass shadow in the lungs [ Time Frame: 14 days ]Kaplan-meier method was used to calculate the median glassy shadow time in all subjects,"Absorption of Lung shadow absorption by CT Scan-Chest [ Time Frame: 7, 14, 28 and 360 days ]Kaplan-meier method was used to calculate the median lung shadow absorption of all subjects on 7, 14, 28, and 360 days
Changes of blood oxygen [ Time Frame: 3, 7 and 14 days ]T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14 Changes of blood oxygen [ Time Frame: 3, 7 and 14 days ]T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14",24
89,Not yet recruiting,Not Applicable,All,"18 Years to 100 Years   (Adult, Older Adult)",NCT04295551,Clinical recovery time [ Time Frame: Up to Day 28 ]The time from study drug use to complete fever reduction and cough recovery is measured in hours.,"Aged >=18 years; Novel coronavirus pneumonia patients diagnosed by pathogenic testing; The patient himself participated in the study voluntarily, agreed and signed the informed consent.",80
90,Not yet recruiting,"Phase 2
Phase 3",All,"18 Years and older   (Adult, Older Adult)",NCT04321616,In-hospital mortality [ Time Frame: 3 weeks ]All cause in-hospital mortality,"Occurrence and duration of mechanical ventilation [ Time Frame: 3 weeks ]
Occurrence and duration of intensive care unit (ICU) treatment [ Time Frame: 3 weeks ]
Duration of hospital admittance [ Time Frame: 1 month ]
28 Day mortality [ Time Frame: 3 weeks ]
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen [ Time Frame: 3 weeks ]
Occurrence of co-infections [ Time Frame: 3 weeks ]
Occurrence of organ dysfunction [ Time Frame: 3 months ] Occurrence and duration of intensive care unit (ICU) treatment [ Time Frame: 3 weeks ]
Duration of hospital admittance [ Time Frame: 1 month ]
28 Day mortality [ Time Frame: 3 weeks ]
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen [ Time Frame: 3 weeks ]
Occurrence of co-infections [ Time Frame: 3 weeks ]
Occurrence of organ dysfunction [ Time Frame: 3 months ] Duration of hospital admittance [ Time Frame: 1 month ]
28 Day mortality [ Time Frame: 3 weeks ]
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen [ Time Frame: 3 weeks ]
Occurrence of co-infections [ Time Frame: 3 weeks ]
Occurrence of organ dysfunction [ Time Frame: 3 months ] 28 Day mortality [ Time Frame: 3 weeks ]
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen [ Time Frame: 3 weeks ]
Occurrence of co-infections [ Time Frame: 3 weeks ]
Occurrence of organ dysfunction [ Time Frame: 3 months ] Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen [ Time Frame: 3 weeks ]
Occurrence of co-infections [ Time Frame: 3 weeks ]
Occurrence of organ dysfunction [ Time Frame: 3 months ] Occurrence of co-infections [ Time Frame: 3 weeks ]
Occurrence of organ dysfunction [ Time Frame: 3 months ] Occurrence of organ dysfunction [ Time Frame: 3 months ]",700
91,Recruiting,Phase 3,All,"18 Years to 65 Years   (Adult, Older Adult)",NCT04320238,new-onset COVID-19 [ Time Frame: coronavirus disease-2019 diagnosed during 28-day intervention. ]new-onset coronavirus disease-2019,"new-onset coronavirus related symptoms [ Time Frame: during 28-day intervention. ]new-onset fever or respiratory symptoms but with negative pulmonary images evidence.
adverse effect [ Time Frame: during 28-day intervention. ]adverse effect of interferon α adverse effect [ Time Frame: during 28-day intervention. ]adverse effect of interferon α",2944
92,Not yet recruiting,Not Applicable,All,"18 Years to 100 Years   (Adult, Older Adult)",NCT04324528,interleukin-6 (IL-6) level after 72 hours [ Time Frame: 72 hours ]measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption),"30-day-survival [ Time Frame: 72 hours ]survival after 30 days
vasopressor dosage [ Time Frame: 72 hours ]needed dosage of norepinephrin and other vasopressors
fluid balance [ Time Frame: 72 hours ]fluid balance levels during cytokine adsorptio
lactate [ Time Frame: 72 hours ]serum-lactate levels during cytokine adsorption vasopressor dosage [ Time Frame: 72 hours ]needed dosage of norepinephrin and other vasopressors
fluid balance [ Time Frame: 72 hours ]fluid balance levels during cytokine adsorptio
lactate [ Time Frame: 72 hours ]serum-lactate levels during cytokine adsorption fluid balance [ Time Frame: 72 hours ]fluid balance levels during cytokine adsorptio
lactate [ Time Frame: 72 hours ]serum-lactate levels during cytokine adsorption lactate [ Time Frame: 72 hours ]serum-lactate levels during cytokine adsorption",30
93,Recruiting,,All,"Child, Adult, Older Adult",NCT04323787,ICU and hospital mortality of COVID-19 patients [ Time Frame: 7 days ]Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients,30 days mortality [ Time Frame: 30 days ]Secondary outcome will be to measure 30 days mortality from Hospital discharge,50000
94,Recruiting,,All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04306705,"Proportion of Participants With Normalization of Fever and Oxygen Saturation Through Day 14 [ Time Frame: First dose date up to 14 days ]This is a composite outcome measure. Criteria for fever normalization: Temperature < 36.6 °C armpit, < 37.2 °C oral sustained for at least 72 hours and criteria for oxygen normalization: peripheral capillary oxygen saturation (Sp02) > 94% sustained for at least 72 hours.","Duration of hospitalization [ Time Frame: Up to 28 days ]Measured in days
Proportion of Participants With Normalization of Fever Through Day 14 [ Time Frame: First dose date up to 14 days ]Criteria for: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 72 hours.
Change from baseline in white blood cell and differential count [ Time Frame: Day 1 through Day 28 ]Blood routine test
Time to first negative in 2019 novel Corona virus RT-PCR test [ Time Frame: Up to 28 days ]Oropharyngeal or anal swabs
All-cause mortality [ Time Frame: up to 12 weeks ]Date and cause of death (if applicable).
Change from baseline in hsCRP [ Time Frame: Day 1 through Day 28 ]Serum hsCRP
Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α [ Time Frame: Day 1 through Day 28 ]Serum inflammatory cytokines
Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells [ Time Frame: Day 1 through Day 28 (if applicable) ]Flow cytometry for peripheral whole blood Proportion of Participants With Normalization of Fever Through Day 14 [ Time Frame: First dose date up to 14 days ]Criteria for: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 72 hours.
Change from baseline in white blood cell and differential count [ Time Frame: Day 1 through Day 28 ]Blood routine test
Time to first negative in 2019 novel Corona virus RT-PCR test [ Time Frame: Up to 28 days ]Oropharyngeal or anal swabs
All-cause mortality [ Time Frame: up to 12 weeks ]Date and cause of death (if applicable).
Change from baseline in hsCRP [ Time Frame: Day 1 through Day 28 ]Serum hsCRP
Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α [ Time Frame: Day 1 through Day 28 ]Serum inflammatory cytokines
Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells [ Time Frame: Day 1 through Day 28 (if applicable) ]Flow cytometry for peripheral whole blood Change from baseline in white blood cell and differential count [ Time Frame: Day 1 through Day 28 ]Blood routine test
Time to first negative in 2019 novel Corona virus RT-PCR test [ Time Frame: Up to 28 days ]Oropharyngeal or anal swabs
All-cause mortality [ Time Frame: up to 12 weeks ]Date and cause of death (if applicable).
Change from baseline in hsCRP [ Time Frame: Day 1 through Day 28 ]Serum hsCRP
Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α [ Time Frame: Day 1 through Day 28 ]Serum inflammatory cytokines
Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells [ Time Frame: Day 1 through Day 28 (if applicable) ]Flow cytometry for peripheral whole blood Time to first negative in 2019 novel Corona virus RT-PCR test [ Time Frame: Up to 28 days ]Oropharyngeal or anal swabs
All-cause mortality [ Time Frame: up to 12 weeks ]Date and cause of death (if applicable).
Change from baseline in hsCRP [ Time Frame: Day 1 through Day 28 ]Serum hsCRP
Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α [ Time Frame: Day 1 through Day 28 ]Serum inflammatory cytokines
Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells [ Time Frame: Day 1 through Day 28 (if applicable) ]Flow cytometry for peripheral whole blood All-cause mortality [ Time Frame: up to 12 weeks ]Date and cause of death (if applicable).
Change from baseline in hsCRP [ Time Frame: Day 1 through Day 28 ]Serum hsCRP
Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α [ Time Frame: Day 1 through Day 28 ]Serum inflammatory cytokines
Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells [ Time Frame: Day 1 through Day 28 (if applicable) ]Flow cytometry for peripheral whole blood Change from baseline in hsCRP [ Time Frame: Day 1 through Day 28 ]Serum hsCRP
Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α [ Time Frame: Day 1 through Day 28 ]Serum inflammatory cytokines
Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells [ Time Frame: Day 1 through Day 28 (if applicable) ]Flow cytometry for peripheral whole blood Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α [ Time Frame: Day 1 through Day 28 ]Serum inflammatory cytokines
Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells [ Time Frame: Day 1 through Day 28 (if applicable) ]Flow cytometry for peripheral whole blood Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells [ Time Frame: Day 1 through Day 28 (if applicable) ]Flow cytometry for peripheral whole blood",120
95,Not yet recruiting,Not Applicable,All,"18 Years to 85 Years   (Adult, Older Adult)",NCT04285190,"The time to oxygen saturation recovery to normal level (≥97%) [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, oxygen saturation will be assessed for 3 times daily, the time to oxygen saturation recovery to normal level (≥97%) will be calculated finally based on that record and compared between two groups.
The proportion of patients with normal level of oxygen saturation(≥97%) [ Time Frame: Day -1 to 10 ]The proportion of patients with normal level of oxygen saturation(≥97%) after treatment will be calculated finally based on that record and compared between two groups. The proportion of patients with normal level of oxygen saturation(≥97%) [ Time Frame: Day -1 to 10 ]The proportion of patients with normal level of oxygen saturation(≥97%) after treatment will be calculated finally based on that record and compared between two groups.","The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc. [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the symptoms will be assessed 2 times daily, and the time to achievement of remission for each symptom will be calculated finally based on the record and compared between two groups.
The time to the myocardial enzyme spectrum recovery to normal after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal myocardial enzyme spectrum after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal myocardial enzyme spectrum after treatment will be calculated finally based on the record and compared between two groups.
The time to the electrocardiogram recovery to normal level after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal electrocardiogram after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.
The time to the hemodynamics recovery to normal after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal hemodynamics after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The time to the myocardial enzyme spectrum recovery to normal after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal myocardial enzyme spectrum after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal myocardial enzyme spectrum after treatment will be calculated finally based on the record and compared between two groups.
The time to the electrocardiogram recovery to normal level after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal electrocardiogram after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.
The time to the hemodynamics recovery to normal after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal hemodynamics after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The proportion of the patients with normal myocardial enzyme spectrum after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal myocardial enzyme spectrum after treatment will be calculated finally based on the record and compared between two groups.
The time to the electrocardiogram recovery to normal level after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal electrocardiogram after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.
The time to the hemodynamics recovery to normal after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal hemodynamics after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The time to the electrocardiogram recovery to normal level after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal electrocardiogram after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.
The time to the hemodynamics recovery to normal after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal hemodynamics after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The proportion of the patients with normal electrocardiogram after treatment [ Time Frame: Day -1, 3, 7 and 10 ]From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.
The time to the hemodynamics recovery to normal after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal hemodynamics after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The time to the hemodynamics recovery to normal after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
The proportion of the patients with normal hemodynamics after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The proportion of the patients with normal hemodynamics after treatment [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The all-cause mortality rate [ Time Frame: Day -1 to 10 ]For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups. The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups.",120
96,Not yet recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04325048,"Device: Cordio App
Adult patients positive to COVID19 virus will record several predefined sentences via a smartphone / tablet and will answer questions via the app",Voice anaysis [ Time Frame: 1-2 years ]patient voice that is recorded during the study will be anylaysis with specific algorithms,5000
97,Not yet recruiting,"Phase 1
Phase 2",All,18 Years to 55 Years   (Adult),NCT04324606,"Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases [ Time Frame: 6 months ]Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19
Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs) [ Time Frame: 6 months ]Occurrence of serious adverse events (SAEs) throughout the study duration Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs) [ Time Frame: 6 months ]Occurrence of serious adverse events (SAEs) throughout the study duration","Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms [ Time Frame: 7 days following vaccination ]Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms [ Time Frame: 7 days following vaccination ]Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs) [ Time Frame: 28 days following vaccination ]Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests [ Time Frame: 6 months ]Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes [ Time Frame: 6 months ]Occurrence of disease enhancement episodes
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of deaths associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms [ Time Frame: 7 days following vaccination ]Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs) [ Time Frame: 28 days following vaccination ]Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests [ Time Frame: 6 months ]Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes [ Time Frame: 6 months ]Occurrence of disease enhancement episodes
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of deaths associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs) [ Time Frame: 28 days following vaccination ]Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests [ Time Frame: 6 months ]Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes [ Time Frame: 6 months ]Occurrence of disease enhancement episodes
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of deaths associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests [ Time Frame: 6 months ]Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes [ Time Frame: 6 months ]Occurrence of disease enhancement episodes
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of deaths associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes [ Time Frame: 6 months ]Occurrence of disease enhancement episodes
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of deaths associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of deaths associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of hospital admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 [ Time Frame: 6 months ]Number of intensive care unit admissions associated with COVID-19
Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays [ Time Frame: 6 months ]Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 [ Time Frame: 6 months ]Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)",510
98,Not yet recruiting,"Phase 1
Phase 2",All,"18 Years to 110 Years   (Adult, Older Adult)",NCT04321096,Days to clinical improvement from study enrolment [ Time Frame: 30 days ]Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale,"Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs) [ Time Frame: 30 days ]
Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30 [ Time Frame: 30 days ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Day 30 mortality [ Time Frame: 30 days ]Mortality
Change in NEW(2) score from baseline to day 30 [ Time Frame: 30 days ]NEWS2
Admission to ICU [ Time Frame: 30 days ]ICU
Use of invasive mechanical ventilation or ECMO [ Time Frame: 30 days ]invasive mechanical ventilation or ECMO
Duration of supplemental oxygen (days) [ Time Frame: 30 days ]Nasal or high-flow oxygen
Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]Subjective clinical improvement Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30 [ Time Frame: 30 days ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Day 30 mortality [ Time Frame: 30 days ]Mortality
Change in NEW(2) score from baseline to day 30 [ Time Frame: 30 days ]NEWS2
Admission to ICU [ Time Frame: 30 days ]ICU
Use of invasive mechanical ventilation or ECMO [ Time Frame: 30 days ]invasive mechanical ventilation or ECMO
Duration of supplemental oxygen (days) [ Time Frame: 30 days ]Nasal or high-flow oxygen
Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]Subjective clinical improvement Day 30 mortality [ Time Frame: 30 days ]Mortality
Change in NEW(2) score from baseline to day 30 [ Time Frame: 30 days ]NEWS2
Admission to ICU [ Time Frame: 30 days ]ICU
Use of invasive mechanical ventilation or ECMO [ Time Frame: 30 days ]invasive mechanical ventilation or ECMO
Duration of supplemental oxygen (days) [ Time Frame: 30 days ]Nasal or high-flow oxygen
Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]Subjective clinical improvement Change in NEW(2) score from baseline to day 30 [ Time Frame: 30 days ]NEWS2
Admission to ICU [ Time Frame: 30 days ]ICU
Use of invasive mechanical ventilation or ECMO [ Time Frame: 30 days ]invasive mechanical ventilation or ECMO
Duration of supplemental oxygen (days) [ Time Frame: 30 days ]Nasal or high-flow oxygen
Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]Subjective clinical improvement Admission to ICU [ Time Frame: 30 days ]ICU
Use of invasive mechanical ventilation or ECMO [ Time Frame: 30 days ]invasive mechanical ventilation or ECMO
Duration of supplemental oxygen (days) [ Time Frame: 30 days ]Nasal or high-flow oxygen
Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]Subjective clinical improvement Use of invasive mechanical ventilation or ECMO [ Time Frame: 30 days ]invasive mechanical ventilation or ECMO
Duration of supplemental oxygen (days) [ Time Frame: 30 days ]Nasal or high-flow oxygen
Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]Subjective clinical improvement Duration of supplemental oxygen (days) [ Time Frame: 30 days ]Nasal or high-flow oxygen
Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]Subjective clinical improvement Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 [ Time Frame: 30 days ]Subjective clinical improvement",180
99,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04323800,"Cumulative incidence of composite outcome of disease severity [ Time Frame: Day 28 ]The cumulative incidence of composite outcome of disease severity will be used in assessing the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19. This will be determined with the presence or occurrence of at least one of the following:

Death
Requiring mechanical ventilation and/or in ICU
non-ICU hospitalization, requiring supplemental oxygen;
non-ICU hospitalization, not requiring supplemental oxygen;
Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection
Not hospitalized, no clinical evidence of COVID-19 infection, but with positive PCR for SARS-CoV-2 Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection Not hospitalized, no clinical evidence of COVID-19 infection, but with positive PCR for SARS-CoV-2","Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection Not hospitalized, no clinical evidence of COVID-19 infection, but with positive PCR for SARS-CoV-2",150
100,Recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04316884,"Acute Kidney Injury [ Time Frame: During Intensive Care, an estimated average of 10 days. ]KDIGO AKI score","ARDS [ Time Frame: During intensive care, an estimated average of 10 days. ]Acute Respiratory Distress Syndrome yes/no
30 day mortality [ Time Frame: 30 days ]Death within 30 days of ICU admission
1 year mortality [ Time Frame: 1 year ]Death within 1 year of ICU admission
Chronic Kidney Disease [ Time Frame: 60 days and 1 year after ICU admission ]Development of Chronic Kidney Disease
SOFA-score [ Time Frame: During Intensive Care, an estimated average of 10 days. ]Sequential Organ Failure Score as a continuous variable 30 day mortality [ Time Frame: 30 days ]Death within 30 days of ICU admission
1 year mortality [ Time Frame: 1 year ]Death within 1 year of ICU admission
Chronic Kidney Disease [ Time Frame: 60 days and 1 year after ICU admission ]Development of Chronic Kidney Disease
SOFA-score [ Time Frame: During Intensive Care, an estimated average of 10 days. ]Sequential Organ Failure Score as a continuous variable 1 year mortality [ Time Frame: 1 year ]Death within 1 year of ICU admission
Chronic Kidney Disease [ Time Frame: 60 days and 1 year after ICU admission ]Development of Chronic Kidney Disease
SOFA-score [ Time Frame: During Intensive Care, an estimated average of 10 days. ]Sequential Organ Failure Score as a continuous variable Chronic Kidney Disease [ Time Frame: 60 days and 1 year after ICU admission ]Development of Chronic Kidney Disease
SOFA-score [ Time Frame: During Intensive Care, an estimated average of 10 days. ]Sequential Organ Failure Score as a continuous variable SOFA-score [ Time Frame: During Intensive Care, an estimated average of 10 days. ]Sequential Organ Failure Score as a continuous variable",100
101,Recruiting,,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04312100,Incidence of respiratory failure [ Time Frame: 28 day ]Incidence of respiratory failure at day 28 after enrollment,28 day mortality rate [ Time Frame: 28 day ]mortality rate at day 28 after enrollment,30
102,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04312009,"Sequential Organ Failure Assessment (SOFA) Respiratory Score [ Time Frame: 28 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure).
Outcome is reported as only the respiratory component score. Respiratory scores range from 0-4, with higher scores indicating greater chance of mortality due to respiratory failure.","28-Day Mortality [ Time Frame: 28 days ]Outcome reported as the number of participants who have expired at 28 days post enrollment.
90-Day Mortality [ Time Frame: 90 days ]Outcome reported as the number of participants who have expired at 90 days post enrollment.
Respiratory Failure Requiring Mechanical Ventilation [ Time Frame: 7 days ]Outcome reported as the number of participants receiving in-patient hospital care requiring mechanical ventilation due to respiratory failure.
Number of 28-Day Ventilator-Free Days [ Time Frame: 28 days ]Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Length of Hospital Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
ICU Admission [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
ICU Length of Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Acute Kidney Injury [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
Urine output less than 0.5 mL/kg/h for 6 hours.

Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. 90-Day Mortality [ Time Frame: 90 days ]Outcome reported as the number of participants who have expired at 90 days post enrollment.
Respiratory Failure Requiring Mechanical Ventilation [ Time Frame: 7 days ]Outcome reported as the number of participants receiving in-patient hospital care requiring mechanical ventilation due to respiratory failure.
Number of 28-Day Ventilator-Free Days [ Time Frame: 28 days ]Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Length of Hospital Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
ICU Admission [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
ICU Length of Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Acute Kidney Injury [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
Urine output less than 0.5 mL/kg/h for 6 hours.

Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Respiratory Failure Requiring Mechanical Ventilation [ Time Frame: 7 days ]Outcome reported as the number of participants receiving in-patient hospital care requiring mechanical ventilation due to respiratory failure.
Number of 28-Day Ventilator-Free Days [ Time Frame: 28 days ]Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Length of Hospital Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
ICU Admission [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
ICU Length of Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Acute Kidney Injury [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
Urine output less than 0.5 mL/kg/h for 6 hours.

Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Number of 28-Day Ventilator-Free Days [ Time Frame: 28 days ]Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Length of Hospital Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
ICU Admission [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
ICU Length of Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Acute Kidney Injury [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
Urine output less than 0.5 mL/kg/h for 6 hours.

Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Length of Hospital Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
ICU Admission [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
ICU Length of Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Acute Kidney Injury [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
Urine output less than 0.5 mL/kg/h for 6 hours.

Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. ICU Admission [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
ICU Length of Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Acute Kidney Injury [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
Urine output less than 0.5 mL/kg/h for 6 hours.

Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. ICU Length of Stay [ Time Frame: approximately 28 days ]Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Acute Kidney Injury [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
Urine output less than 0.5 mL/kg/h for 6 hours.

Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Acute Kidney Injury [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines:

Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR
Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR
Urine output less than 0.5 mL/kg/h for 6 hours.

Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours. Hypotension Requiring Vasopressors [ Time Frame: approximately 28 days ]Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Sequential Organ Failure Assessment (SOFA) Total Score [ Time Frame: approximately 14 days ]The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Severity Assessment [ Time Frame: 15 days ]Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Incidence of Respiratory Failure [ Time Frame: approximately 28 days ]Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless. Oxygen Saturation / Fractional Inhaled Oxygen (F/S) [ Time Frame: 72 hours ]Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.",200
103,Not yet recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04323878,"To monitor and describe the COVID-19 patients visiting Italian EDs. To assess the prognostic impact of demographics, clinical characteristics, risk factors and pre-existing diseases. To develop a predictive model, providing estimates of the prognosis using multiple relevant factors. To construct a detailed database to enable comparative effectiveness research (CER), with the goal of generating hypothesis of efficacy and effectiveness of treatments, therapies and interventions, in the management and treatment of COVID-19 patients.",Death or need of intubation [ Time Frame: 7 days since ED arrival ]The study outcomes will be death or need of intubation within 7 days since ED arrival.,3000
104,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04315948,"Percentage of subjects reporting each severity rating on a 7-point ordinal scale [ Time Frame: Day 15 ]
Not hospitalized, no limitations on activities
Not hospitalized, limitation on activities;
Hospitalized, not requiring supplemental oxygen;
Hospitalized, requiring supplemental oxygen;
Hospitalized, on non-invasive ventilation or high flow oxygen devices;
Hospitalized, on invasive mechanical ventilation or ECMO;
Death. Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.","Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.",3100
105,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04311177,Hospital Admission [ Time Frame: 28 days ]Outcome reported as the number of participants per arm admitted to inpatient hospital care due to COVID-19-related disease.,"Change in PROMIS Dyspnea Functional Limitations [ Time Frame: baseline, 10 days ]The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea.
In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.
Change in PROMIS Dyspnea Severity [ Time Frame: baseline, 10 days ]The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea.
The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.
Fever Incidence Day 3 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 3.
Fever Incidence Day 5 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 5.
Fever Incidence Day 7 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 7.
Fever Incidence Day 10 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 10.
Severity of Symptoms upon Hospital Admission [ Time Frame: 28 days ]Outcome is reported as the number of participants in each arm who are admitted to inpatient hospital care and who present with organ failure (as determined by physician) at the time of admission. Change in PROMIS Dyspnea Severity [ Time Frame: baseline, 10 days ]The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea.
The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.
Fever Incidence Day 3 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 3.
Fever Incidence Day 5 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 5.
Fever Incidence Day 7 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 7.
Fever Incidence Day 10 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 10.
Severity of Symptoms upon Hospital Admission [ Time Frame: 28 days ]Outcome is reported as the number of participants in each arm who are admitted to inpatient hospital care and who present with organ failure (as determined by physician) at the time of admission. Fever Incidence Day 3 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 3.
Fever Incidence Day 5 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 5.
Fever Incidence Day 7 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 7.
Fever Incidence Day 10 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 10.
Severity of Symptoms upon Hospital Admission [ Time Frame: 28 days ]Outcome is reported as the number of participants in each arm who are admitted to inpatient hospital care and who present with organ failure (as determined by physician) at the time of admission. Fever Incidence Day 5 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 5.
Fever Incidence Day 7 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 7.
Fever Incidence Day 10 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 10.
Severity of Symptoms upon Hospital Admission [ Time Frame: 28 days ]Outcome is reported as the number of participants in each arm who are admitted to inpatient hospital care and who present with organ failure (as determined by physician) at the time of admission. Fever Incidence Day 7 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 7.
Fever Incidence Day 10 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 10.
Severity of Symptoms upon Hospital Admission [ Time Frame: 28 days ]Outcome is reported as the number of participants in each arm who are admitted to inpatient hospital care and who present with organ failure (as determined by physician) at the time of admission. Fever Incidence Day 10 [ Time Frame: 10 days ]Participants will record oral temperature every day for 10 days. Outcome is reported as body temperature (in degrees Celsius) at day 10.
Severity of Symptoms upon Hospital Admission [ Time Frame: 28 days ]Outcome is reported as the number of participants in each arm who are admitted to inpatient hospital care and who present with organ failure (as determined by physician) at the time of admission. Severity of Symptoms upon Hospital Admission [ Time Frame: 28 days ]Outcome is reported as the number of participants in each arm who are admitted to inpatient hospital care and who present with organ failure (as determined by physician) at the time of admission.",516
106,Recruiting,,All,"Child, Adult, Older Adult",NCT04313946,"specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19; the objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza; this software will be trained by introducing X-Rays from patients with/without COVID-19 pneumonitis and/or flu pneumonitis; the same AI algorithm will run on future X-Ray scans for predicting possible COVID-19 pneumonitis","COVID-19 positive X-Rays [ Time Frame: 6 months ]Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive
COVID-19 negative X-Rays [ Time Frame: 6 months ]Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative COVID-19 negative X-Rays [ Time Frame: 6 months ]Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative",200
107,Not yet recruiting,Not Applicable,All,"18 Years to 65 Years   (Adult, Older Adult)",NCT04273646,"Pneumonia severity index [ Time Frame: From Baseline (0W) to 12 week after treatment ]Evaluation of Pneumonia Improvement
Oxygenation index (PaO2/FiO2) [ Time Frame: From Baseline (0W) to 12 week after treatment ]Evaluation of Pneumonia Improvement Oxygenation index (PaO2/FiO2) [ Time Frame: From Baseline (0W) to 12 week after treatment ]Evaluation of Pneumonia Improvement","Side effects in the UC-MSCs treatment group [ Time Frame: From Baseline (0W) to 96 week after treatment ]Incidence of acute and chronic treatment-related adverse events in patients with novel coronavirus severe pneumonia receiving UC-MSCs infusion as assessed.
28-days survival [ Time Frame: Day 28 ]Marker for efficacy of treatment
Sequential organ failure assessment [ Time Frame: Day 28 ]Markers of organ function（Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.）
C-reactive protein [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Procalcitonin [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Lymphocyte count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD3+, CD4+ and CD8+ T celll count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD4+/CD8+ratio [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function 28-days survival [ Time Frame: Day 28 ]Marker for efficacy of treatment
Sequential organ failure assessment [ Time Frame: Day 28 ]Markers of organ function（Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.）
C-reactive protein [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Procalcitonin [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Lymphocyte count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD3+, CD4+ and CD8+ T celll count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD4+/CD8+ratio [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function Sequential organ failure assessment [ Time Frame: Day 28 ]Markers of organ function（Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.）
C-reactive protein [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Procalcitonin [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Lymphocyte count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD3+, CD4+ and CD8+ T celll count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD4+/CD8+ratio [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function C-reactive protein [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Procalcitonin [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Lymphocyte count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD3+, CD4+ and CD8+ T celll count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD4+/CD8+ratio [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function Procalcitonin [ Time Frame: From Baseline (0W) to 12 week after treatment ]Markers of Infection
Lymphocyte count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD3+, CD4+ and CD8+ T celll count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD4+/CD8+ratio [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function Lymphocyte count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD3+, CD4+ and CD8+ T celll count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD4+/CD8+ratio [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function CD3+, CD4+ and CD8+ T celll count [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function
CD4+/CD8+ratio [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function CD4+/CD8+ratio [ Time Frame: From Baseline (0W) to 12 week after treatment ]Marker of Immunological function",48
108,Not yet recruiting,Phase 4,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04260594,Virus negative conversion rate in the first week [ Time Frame: first week ],"Virus negative conversion rate [ Time Frame: 14-20 days ]virus negative conversion rate in second week, overall virus negative conversion rate
Antipyretic rate [ Time Frame: 14-20 days ]defined as: the rate of Axillary temperature ≤37.5 ℃ for at least 48h
Symptom relief time [ Time Frame: 14-20 days ]time to relieve symptoms of fever, cough, dyspnea, myalgia, etc
Finger oxygen improvement rate [ Time Frame: 14-20 days ]no adjuvant oxygen therapy, resting oxygen saturation＞95%, oxygenation index＞350
Disease progression rate [ Time Frame: 14-20 days ]Mild, common type progression to severe or critical illness rate
Mortality rate [ Time Frame: 14-20 days ]
Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ] Antipyretic rate [ Time Frame: 14-20 days ]defined as: the rate of Axillary temperature ≤37.5 ℃ for at least 48h
Symptom relief time [ Time Frame: 14-20 days ]time to relieve symptoms of fever, cough, dyspnea, myalgia, etc
Finger oxygen improvement rate [ Time Frame: 14-20 days ]no adjuvant oxygen therapy, resting oxygen saturation＞95%, oxygenation index＞350
Disease progression rate [ Time Frame: 14-20 days ]Mild, common type progression to severe or critical illness rate
Mortality rate [ Time Frame: 14-20 days ]
Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ] Symptom relief time [ Time Frame: 14-20 days ]time to relieve symptoms of fever, cough, dyspnea, myalgia, etc
Finger oxygen improvement rate [ Time Frame: 14-20 days ]no adjuvant oxygen therapy, resting oxygen saturation＞95%, oxygenation index＞350
Disease progression rate [ Time Frame: 14-20 days ]Mild, common type progression to severe or critical illness rate
Mortality rate [ Time Frame: 14-20 days ]
Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ] Finger oxygen improvement rate [ Time Frame: 14-20 days ]no adjuvant oxygen therapy, resting oxygen saturation＞95%, oxygenation index＞350
Disease progression rate [ Time Frame: 14-20 days ]Mild, common type progression to severe or critical illness rate
Mortality rate [ Time Frame: 14-20 days ]
Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ] Disease progression rate [ Time Frame: 14-20 days ]Mild, common type progression to severe or critical illness rate
Mortality rate [ Time Frame: 14-20 days ]
Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ] Mortality rate [ Time Frame: 14-20 days ]
Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ] Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ] Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ]",380
109,Not yet recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04314232,Change in viral expression in association to organspecific biomarkers [ Time Frame: Day 1 and Day 3 ],All patients >18 years of age with a positive test for SARS-CoV2 are eligble for inclusion. Healty age-matched volunteers will be included as a control group,200
110,Recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04321811,"who are feeling sick but have not tested positive for COVID-19, or who are feeling sick and have tested positive for COVID-19, or who are not feeling sick but want to participate can enroll",who are feeling sick but have not tested positive for COVID-19 who are feeling sick and have tested positive for COVID-19 People who are not feeling sick but want to participate,100000
111,Recruiting,"Phase 2
Phase 3",All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04275414,"Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio [ Time Frame: 24 hours ]Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio [ Time Frame: 72 hours ]Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio [ Time Frame: 7 days ]Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio [ Time Frame: 72 hours ]Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio [ Time Frame: 7 days ]Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio [ Time Frame: 7 days ]Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio","Degree of dyspnea (Liker scale) [ Time Frame: 72 hours ]Liker scale: The patient grades his current breathing compared to when he first started the drug (from -3 to 3). ""0"" = no change, ""1"" =minimally better, ""2"" =moderately better, ""3"" =markedly better, ""-1"" =minimally worse, ""-2"" =moderately worse, ""-3"" =markedly worse
Degree of dyspnea (Liker scale) [ Time Frame: 7 days ]The patient grades the current breathing condition of himself compared to when he first started the drug (from -3 to 3).
Degree of dyspnea (VAS) [ Time Frame: 72 hours ]Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number ""0"" equals the worst breathing the patient has ever felt and the number ""100"" equals the best he has ever felt.
Degree of dyspnea (VAS) [ Time Frame: 7 days ]Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number ""0"" equals the worst breathing the patient has ever felt and the number ""100"" equals the best he has ever felt.
The area of lung lesions on Chest CT [ Time Frame: 7 days ]The degree of exudation on Chest CT
The degree of lung exudation on Chest CT [ Time Frame: 7 days ]The degree of lung exudation on Chest CT
SpO2 [ Time Frame: 24 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 72 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality Degree of dyspnea (Liker scale) [ Time Frame: 7 days ]The patient grades the current breathing condition of himself compared to when he first started the drug (from -3 to 3).
Degree of dyspnea (VAS) [ Time Frame: 72 hours ]Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number ""0"" equals the worst breathing the patient has ever felt and the number ""100"" equals the best he has ever felt.
Degree of dyspnea (VAS) [ Time Frame: 7 days ]Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number ""0"" equals the worst breathing the patient has ever felt and the number ""100"" equals the best he has ever felt.
The area of lung lesions on Chest CT [ Time Frame: 7 days ]The degree of exudation on Chest CT
The degree of lung exudation on Chest CT [ Time Frame: 7 days ]The degree of lung exudation on Chest CT
SpO2 [ Time Frame: 24 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 72 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality Degree of dyspnea (VAS) [ Time Frame: 72 hours ]Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number ""0"" equals the worst breathing the patient has ever felt and the number ""100"" equals the best he has ever felt.
Degree of dyspnea (VAS) [ Time Frame: 7 days ]Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number ""0"" equals the worst breathing the patient has ever felt and the number ""100"" equals the best he has ever felt.
The area of lung lesions on Chest CT [ Time Frame: 7 days ]The degree of exudation on Chest CT
The degree of lung exudation on Chest CT [ Time Frame: 7 days ]The degree of lung exudation on Chest CT
SpO2 [ Time Frame: 24 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 72 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality Degree of dyspnea (VAS) [ Time Frame: 7 days ]Visual analog scale (VAS): The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he feels about breathing. The number ""0"" equals the worst breathing the patient has ever felt and the number ""100"" equals the best he has ever felt.
The area of lung lesions on Chest CT [ Time Frame: 7 days ]The degree of exudation on Chest CT
The degree of lung exudation on Chest CT [ Time Frame: 7 days ]The degree of lung exudation on Chest CT
SpO2 [ Time Frame: 24 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 72 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality The area of lung lesions on Chest CT [ Time Frame: 7 days ]The degree of exudation on Chest CT
The degree of lung exudation on Chest CT [ Time Frame: 7 days ]The degree of lung exudation on Chest CT
SpO2 [ Time Frame: 24 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 72 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality The degree of lung exudation on Chest CT [ Time Frame: 7 days ]The degree of lung exudation on Chest CT
SpO2 [ Time Frame: 24 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 72 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality SpO2 [ Time Frame: 24 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 72 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality SpO2 [ Time Frame: 72 hours ]transcutaneous oxygen saturation
SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality SpO2 [ Time Frame: 7 days ]transcutaneous oxygen saturation
PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality PaO2 [ Time Frame: 24 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality PaO2 [ Time Frame: 72 hours ]Partial arterial oxygen pressure
PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality PaO2 [ Time Frame: 7 days ]Partial arterial oxygen pressure
CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality CRP [ Time Frame: 72 hours ]CRP
CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality CRP [ Time Frame: 7 days ]CRP
hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality hs-CRP [ Time Frame: 72 hours ]hs-CRP
hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality hs-CRP [ Time Frame: 7 days ]hs-CRP
All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality All-cause mortality [ Time Frame: 7 days ]All-cause mortality
All-cause mortality [ Time Frame: 14 days ]All-cause mortality All-cause mortality [ Time Frame: 14 days ]All-cause mortality",20
112,Not yet recruiting,,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04324866,Point prevalence of COVID-19 infection [ Time Frame: Baseline up to 6 months ],"Incidence of COVID-19 infection [ Time Frame: Baseline up to 6 months ]
Percentage of subjects presenting fever or respiratory symptoms [ Time Frame: Baseline up to 6 months ]
Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments [ Time Frame: Baseline up to 6 months ]
Evaluate the relationship between COVID-19 infection and comorbid medical conditions [ Time Frame: Baseline up to 6 months ] Percentage of subjects presenting fever or respiratory symptoms [ Time Frame: Baseline up to 6 months ]
Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments [ Time Frame: Baseline up to 6 months ]
Evaluate the relationship between COVID-19 infection and comorbid medical conditions [ Time Frame: Baseline up to 6 months ] Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments [ Time Frame: Baseline up to 6 months ]
Evaluate the relationship between COVID-19 infection and comorbid medical conditions [ Time Frame: Baseline up to 6 months ] Evaluate the relationship between COVID-19 infection and comorbid medical conditions [ Time Frame: Baseline up to 6 months ]",300
113,Completed,Phase 4,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04291729,"Rate of composite adverse outcomes [ Time Frame: 14 days ]Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen","Time to recovery [ Time Frame: 14 days ]Clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough, diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen).
Rate of no fever [ Time Frame: 14 days ]Rate of no fever
Rate of no cough [ Time Frame: 14 days ]Rate of no cough
Rate of no dyspnea [ Time Frame: 14 days ]Rate of no dyspnea
Rate of no requiring supplemental oxygen [ Time Frame: 14 days ]Rate of no requiring supplemental oxygen
Rate of undetectable New coronavirus pathogen nucleic acid [ Time Frame: 14 days ]Rate of undetectable New coronavirus pathogen nucleic acid
Rate of mechanical ventilation [ Time Frame: 14 days ]Rate of mechanical ventilation
Rate of ICU admission [ Time Frame: 14 days ]Rate of ICU admission
Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event Rate of no fever [ Time Frame: 14 days ]Rate of no fever
Rate of no cough [ Time Frame: 14 days ]Rate of no cough
Rate of no dyspnea [ Time Frame: 14 days ]Rate of no dyspnea
Rate of no requiring supplemental oxygen [ Time Frame: 14 days ]Rate of no requiring supplemental oxygen
Rate of undetectable New coronavirus pathogen nucleic acid [ Time Frame: 14 days ]Rate of undetectable New coronavirus pathogen nucleic acid
Rate of mechanical ventilation [ Time Frame: 14 days ]Rate of mechanical ventilation
Rate of ICU admission [ Time Frame: 14 days ]Rate of ICU admission
Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event Rate of no cough [ Time Frame: 14 days ]Rate of no cough
Rate of no dyspnea [ Time Frame: 14 days ]Rate of no dyspnea
Rate of no requiring supplemental oxygen [ Time Frame: 14 days ]Rate of no requiring supplemental oxygen
Rate of undetectable New coronavirus pathogen nucleic acid [ Time Frame: 14 days ]Rate of undetectable New coronavirus pathogen nucleic acid
Rate of mechanical ventilation [ Time Frame: 14 days ]Rate of mechanical ventilation
Rate of ICU admission [ Time Frame: 14 days ]Rate of ICU admission
Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event Rate of no dyspnea [ Time Frame: 14 days ]Rate of no dyspnea
Rate of no requiring supplemental oxygen [ Time Frame: 14 days ]Rate of no requiring supplemental oxygen
Rate of undetectable New coronavirus pathogen nucleic acid [ Time Frame: 14 days ]Rate of undetectable New coronavirus pathogen nucleic acid
Rate of mechanical ventilation [ Time Frame: 14 days ]Rate of mechanical ventilation
Rate of ICU admission [ Time Frame: 14 days ]Rate of ICU admission
Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event Rate of no requiring supplemental oxygen [ Time Frame: 14 days ]Rate of no requiring supplemental oxygen
Rate of undetectable New coronavirus pathogen nucleic acid [ Time Frame: 14 days ]Rate of undetectable New coronavirus pathogen nucleic acid
Rate of mechanical ventilation [ Time Frame: 14 days ]Rate of mechanical ventilation
Rate of ICU admission [ Time Frame: 14 days ]Rate of ICU admission
Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event Rate of undetectable New coronavirus pathogen nucleic acid [ Time Frame: 14 days ]Rate of undetectable New coronavirus pathogen nucleic acid
Rate of mechanical ventilation [ Time Frame: 14 days ]Rate of mechanical ventilation
Rate of ICU admission [ Time Frame: 14 days ]Rate of ICU admission
Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event Rate of mechanical ventilation [ Time Frame: 14 days ]Rate of mechanical ventilation
Rate of ICU admission [ Time Frame: 14 days ]Rate of ICU admission
Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event Rate of ICU admission [ Time Frame: 14 days ]Rate of ICU admission
Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event Rate of serious adverse event [ Time Frame: 14 days ]Rate of serious adverse event",11
114,Recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04325412,cardiac history and cardiovascular risk factors prior use of cardiac medication or NSAIDs electrocardiography (ECG) echocardiography cardiac MRI invasive cardiac procedures cardiac complications cardiac biomarkers cardiac outcome during admission,The incidence of cardiovascular complications in patients with COVID-19 [ Time Frame: 30 days ],1000
115,Not yet recruiting,Not Applicable,All,"18 Years and older   (Adult, Older Adult)",NCT04316728,"take out the test kit and leave it at least 30 minutes in the room where the test will be performed. place the test equipment on a clean and dust-free surface First insert 10µL of whole blood or serum or plasma in the area reserved for blood (in the well) present on the test, then apply 2 drops of buffer. read the result after 15 minutes","The anti-COVID-19 lgM antibody is detected if: the quality control band C and the lgM band are both colored and the lgG band does not stain. This means that the anti-COVID-19 lgM antibody is positive. The anti-COVID-19 lgG antibody is detected if: the quality control band C and the lgG band are both colored and the lgM band does not stain. This means that the COVID-19 lgG antibody is positive. The lgG and lgM anti-COVID-19 antibodies are detected if: the C band, the lgG band and the lgM band are all three colored. This means that the anti-COVID-19 lgG and lgM antibodies are both positive.",200
116,Not yet recruiting,Phase 2,All,"18 Years to 100 Years   (Adult, Older Adult)",NCT04311697,"Mortality [ Time Frame: 5 Days with followup through 30 days ]Mortality
PaO2:FiO2 ratio [ Time Frame: 5 Days with followup through the end of telemetry monitoring ]Index of Respiratory Distress PaO2:FiO2 ratio [ Time Frame: 5 Days with followup through the end of telemetry monitoring ]Index of Respiratory Distress","TNF alpha [ Time Frame: 5 Days ]TNF alpha levels as measured in hospital laboratory
Multi-system organ failure free days [ Time Frame: 5 days with followup through 30 days ]Multi-system organ failure free days Multi-system organ failure free days [ Time Frame: 5 days with followup through 30 days ]Multi-system organ failure free days",120
117,Recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04318314,Seroconversion to SARS-CoV-2 positivity [ Time Frame: Within 6 months ]Home-isolation or hospital admission,healthy asymptomatic healthcare workers attending hospital (place of work),400
118,Recruiting,,All,"Child, Adult, Older Adult",NCT04256395,"Other: mobile internet survey on self-test
1. make a questionnaire, the content of which refers to the new coronavirus diagnosis and treatment guidelines released by the National Health Commission; 2. develop the mobile applet and carry out internet propagation; 3. background data could be identified according to computer technology, de duplication and de privacy; 4. once registered, the applet can automatically remind the self-test twice a day, and encourage to adhere to 14 days; 5. automatically compare with the standards and highly suspected population could be given medical guidance and encouraged to go to the fever clinic of the designated hospital for definite diagnosis.","positive number diagnosed by national guideline in the evaluated population [ Time Frame: 5 months ]after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system",300000
119,Recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04305457,"Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation [ Time Frame: 28 days ]The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.","Mortality [ Time Frame: 28 days ]Proportion of deaths from all causes
Time to clinical recovery [ Time Frame: 28 days ]Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours. Time to clinical recovery [ Time Frame: 28 days ]Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours.",240
120,Not yet recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04324463,"Outpatients: Hospital Admission or Death [ Time Frame: Up to 6 weeks post randomization ]In outpatients with COVID-19, the occurrence of hospital admission or death
Inpatients: Invasive mechanical ventilation or mortality [ Time Frame: Up to 6 weeks post randomization ]Patients intubated or requiring imminent intubation at the time of randomization will only be followed for the primary outcome of death. Inpatients: Invasive mechanical ventilation or mortality [ Time Frame: Up to 6 weeks post randomization ]Patients intubated or requiring imminent intubation at the time of randomization will only be followed for the primary outcome of death.",Age ≥ 18 years of age Informed consent COVID-19 confirmed by established testing,1500
121,Recruiting,Phase 3,All,"18 Years to 85 Years   (Adult, Older Adult)",NCT04320277,The percentage of patients requiring transfer to ICU as compared with the rate of transfers observed in controls. [ Time Frame: 2 weeks ]The percentage of ICU admission in patients and controls will be compared for statistical difference,"The percentage of patients achieving the remission; CRP, IL-6 and TNFα values at baseline and during the treatment course; the number of AEs. [ Time Frame: 2 weeks ]CRP values will be evaluated for prediction of disease worsening.",60
122,Recruiting,Phase 3,All,"18 Years to 99 Years   (Adult, Older Adult)",NCT04280705,"Percentage of subjects reporting each severity rating on an 8-point ordinal scale [ Time Frame: Day 15 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.","Change from baseline in alanine transaminase (ALT) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in aspartate transaminase (AST) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in creatinine [ Time Frame: Day 1 through Day 29 ]
Change from baseline in glucose [ Time Frame: Day 1 through Day 29 ]
Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Change from baseline in prothrombin time (PT) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change from baseline in aspartate transaminase (AST) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in creatinine [ Time Frame: Day 1 through Day 29 ]
Change from baseline in glucose [ Time Frame: Day 1 through Day 29 ]
Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Change from baseline in prothrombin time (PT) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change from baseline in creatinine [ Time Frame: Day 1 through Day 29 ]
Change from baseline in glucose [ Time Frame: Day 1 through Day 29 ]
Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Change from baseline in prothrombin time (PT) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change from baseline in glucose [ Time Frame: Day 1 through Day 29 ]
Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Change from baseline in prothrombin time (PT) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Change from baseline in prothrombin time (PT) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
Change from baseline in prothrombin time (PT) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change from baseline in prothrombin time (PT) [ Time Frame: Day 1 through Day 29 ]
Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change from baseline in white blood cell count with differential [ Time Frame: Day 1 through Day 29 ]
Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Change in National Early Warning Score (NEWS) from baseline [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Clinical status using ordinal scale [ Time Frame: Day 3 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Cumulative incidence of Grade 3 and 4 adverse events (AEs) [ Time Frame: Day 1 through Day 29 ]Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Grade 4 AEs are defined as events that are potentially life threatening.
Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Cumulative incidence of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 29 ]An SAE is defined as an AE or suspected adverse reaction is considered serious is, in the view of either the investigator or the sponsor, if results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Discontinuation or temporary suspension of infusions [ Time Frame: Day 1 through Day 29 ]For any reason.
Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Duration of hospitalization [ Time Frame: Day 1 through Day 29 ]Measured in days.
Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Duration of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Incidence of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Incidence of new oxygen use [ Time Frame: Day 1 through Day 29 ]
Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: Day 1 through Day 29 ]
Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Mean change in the ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Number of non-invasive ventilation/high flow oxygen free days [ Time Frame: Day 1 to Day 29 ]
Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Number of oxygenation free days [ Time Frame: Day 1 to Day 29 ]
Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Subject 14-day mortality [ Time Frame: Day 1 through Day 15 ]Date and cause of death (if applicable).
Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Subject 28-day mortality [ Time Frame: Day 1 through Day 29 ]Date and cause of death (if applicable).
Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Time to an improvement of one category using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Time to an improvement of two categories using an ordinal scale [ Time Frame: Day 1 through Day 29 ]The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first [ Time Frame: Day 1 through Day 29 ]The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ] Ventilator/extracorporeal membrane oxygenation (ECMO) free days [ Time Frame: Day 1 through Day 29 ]",440
123,Not yet recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04321278,"Intervention Group: Hydroxychloroquine + azithromycin. After randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] + azithromycin [500mg 1x/day]) for 10 days. Standard treatment is according to the treatment protocol for 2019-nCoV infection. Active Control Group: Hydroxychloroquine. After randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] for 10 days. Standard treatment is according to the treatment protocol for 2019-nCoV infection.",Evaluation of the clinical status [ Time Frame: 15 days after randomization ]Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 7 points.,440
124,Recruiting,"Phase 2
Phase 3",All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04323592,Consecutively treated with low prolonged doses of methylprednisolone Historical patients never treated with corticosteroids,sex age <10 years difference CRP level at admission (difference <20%) SOFA score (difference <20%) P/F difference <20%,104
125,Withdrawn,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04290858,Reduction in the incidence of intubation and mechanical ventilation [ Time Frame: 28 days ]The primary outcome will be the proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring intubation and mechanical ventilation. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.,"Mortality [ Time Frame: 28 days ]Mortality from all causes
Negative conversion of COVID-19 RT-PCR from upper respiratory tract [ Time Frame: 7 days ]Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab
Time to clinical recovery [ Time Frame: 28 days ]Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent). Negative conversion of COVID-19 RT-PCR from upper respiratory tract [ Time Frame: 7 days ]Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab
Time to clinical recovery [ Time Frame: 28 days ]Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent). Time to clinical recovery [ Time Frame: 28 days ]Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent).",0
126,Not yet recruiting,,All,"Child, Adult, Older Adult",NCT04322487,Right basal on paravertebral line above the curtain sign Right middle on paravertebral line at the inferior angle of shoulder blade Right upper on paravertebral line at spine of shoulder blade Left basal on paravertebral line above the curtain sign Left middle on paravertebral line at the inferior angle of shoulder blade Left upper on paravertebral line at spine of shoulder blade Right basal on mid-axillary line below the internipple line Right upper on mid axillary line above the internipple line Left basal on mid-axillary line below the internipple line Left upper on mid axillary line above the internipple line Right basal on mid-clavicular line below the internipple line Right upper on mid-clavicular line above the internipple line Left basal on mid-clavicular line below the internipple line Left upper on mid-clavicular line above the internipple line,"Use Convex or Linear probes, according to the patient's body size Use single focal point modality (no multifocusing), setting the focal point on the pleura line. Employing a single focal point, and setting it at the right location, has the benefit to optimize the beam shape for sensing the lung surface. At focus, the beam has the smallest width as is therefore set to best respond to the smallest details. Keep the mechanical index (MI) low (start from 0.7 and reduce it further if allowed by the visual findings). High MIs, employed for a long observation time, may result in damaging the lung. Avoid as much as possible saturation phenomena, control gain and diminish MI if needed (see example of lung ultrasound images in the figures). Saturation phenomena occurs, e.g., when the signal streght of the echo signals is too high for the receiving electronics to be converted into electrical signals conserving a linear relation with the pressure amplitude. This has the effect of distorting the signals, and produces images where the dynamics of the actual signal is lost. The visual appearance of this phenomenon is the presence of areas which are completely white. In this case it is therefore not possible to appreciate local variations in the response to insonifications. Avoid the use of cosmetic filters and specific imaging modalities such as Harmonic Imaging, Contrast, Doppler, Compounding. Achieve the highest frame rate possible (e.g. no persistence, no multifocusing) Save the data in DICOM format. In case this is not possible, save the data directly as a video format. Visual findings, especially when related to very small alterations, do not appear on every frame. It is thus advantageous to acquire movies, where the lung surface below the landmark can be monitored for few seconds during breathing.",100
127,Not yet recruiting,Phase 3,All,"18 Months and older   (Child, Adult, Older Adult)",NCT04321174,Kaletra Aluvia,"Microbiologic evidence of infection [ Time Frame: 14 days ]The primary outcome is microbiologically confirmed COVID-19 infection, ie. detection of viral RNA in a respiratory specimen (mid-turbinate swab, nasopharyngeal swab, sputum specimen, saliva specimen, oral swab, endotracheal aspirate, bronchoalveolar lavage specimen) by day 14 of the study.",1220
128,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04257656,"Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ]TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from status at randomisation on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death).
Six-category ordinal scale:
6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen;
1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief).
Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.","Clinical status [ Time Frame: days 7, 14, 21, and 28 ]Clinical status, assessed by the ordinal scale at fixed time points (days 7, 14, 21, and 28).
Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours. [ Time Frame: up to 28 days ]Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.
All cause mortality [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours. [ Time Frame: up to 28 days ]Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.
All cause mortality [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] All cause mortality [ Time Frame: up to 28 days ]
Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] Duration (days) of extracorporeal membrane oxygenation [ Time Frame: up to 28 days ]
Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] Length of hospital stay (days) [ Time Frame: up to 28 days ]
Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens [ Time Frame: up to 28 days ]
Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. [ Time Frame: up to 28 days ]
Frequency of serious adverse drug events [ Time Frame: up to 28 days ] Frequency of serious adverse drug events [ Time Frame: up to 28 days ]",453
129,Available,,All,"18 Years and older   (Adult, Older Adult)",NCT04288713,"Drug: Eculizumab
A distal complement inhibitor.
Other Name: Standard care",COVID-19 positive patients over the age of 18.,
130,Completed,Not Applicable,All,"18 Years to 80 Years   (Adult, Older Adult)",NCT04320953,Technical success [ Time Frame: During the procedure ]Maneuvarability of the remote control MCE system,"Clinical success [ Time Frame: During the procedure ]Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus
Adverse events [ Time Frame: During and within 2 weeks after the procedure ]Adverse events during and after the procedure Adverse events [ Time Frame: During and within 2 weeks after the procedure ]Adverse events during and after the procedure",1
131,Not yet recruiting,Phase 2,All,"18 Years to 85 Years   (Adult, Older Adult)",NCT04322565,"Clinical improvement [ Time Frame: Day 28 ]Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale
Hospital discharge [ Time Frame: Day 28 ]Live discharge from the hospital (whatever comes first) Hospital discharge [ Time Frame: Day 28 ]Live discharge from the hospital (whatever comes first)","Death [ Time Frame: Day 28 ]
Clinical status [ Time Frame: Day 4, 7, Day 14, Day 21 ]7-category ordinal scale
Mechanical venhtilation [ Time Frame: Day 28 ]
Hospitalization [ Time Frame: Day 28 ]
Time from death [ Time Frame: Day 28 ]
Negativization COVID 19 [ Time Frame: Day 21 ]negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Fever [ Time Frame: Day 1,4,7,14,21,28 ]Time to remission of fever in patients with T>37.5°C at enrollment Clinical status [ Time Frame: Day 4, 7, Day 14, Day 21 ]7-category ordinal scale
Mechanical venhtilation [ Time Frame: Day 28 ]
Hospitalization [ Time Frame: Day 28 ]
Time from death [ Time Frame: Day 28 ]
Negativization COVID 19 [ Time Frame: Day 21 ]negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Fever [ Time Frame: Day 1,4,7,14,21,28 ]Time to remission of fever in patients with T>37.5°C at enrollment Mechanical venhtilation [ Time Frame: Day 28 ]
Hospitalization [ Time Frame: Day 28 ]
Time from death [ Time Frame: Day 28 ]
Negativization COVID 19 [ Time Frame: Day 21 ]negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Fever [ Time Frame: Day 1,4,7,14,21,28 ]Time to remission of fever in patients with T>37.5°C at enrollment Hospitalization [ Time Frame: Day 28 ]
Time from death [ Time Frame: Day 28 ]
Negativization COVID 19 [ Time Frame: Day 21 ]negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Fever [ Time Frame: Day 1,4,7,14,21,28 ]Time to remission of fever in patients with T>37.5°C at enrollment Time from death [ Time Frame: Day 28 ]
Negativization COVID 19 [ Time Frame: Day 21 ]negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Fever [ Time Frame: Day 1,4,7,14,21,28 ]Time to remission of fever in patients with T>37.5°C at enrollment Negativization COVID 19 [ Time Frame: Day 21 ]negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Fever [ Time Frame: Day 1,4,7,14,21,28 ]Time to remission of fever in patients with T>37.5°C at enrollment Fever [ Time Frame: Day 1,4,7,14,21,28 ]Time to remission of fever in patients with T>37.5°C at enrollment",100
132,Not yet recruiting,,All,"Child, Adult, Older Adult",NCT04308187,Stress [ Time Frame: Day 1 ]Stress level will be assessed by questionnaire,"Perception and knowledge of the epidemic [ Time Frame: Day 1 ]Perception and knowledge of the epidemic will be assessed by questionnaire
Feeling of information on the part of companies / establishments / governments [ Time Frame: Day 1 ]The feeling of information will be assessed by questionnaire
Means of protection [ Time Frame: Day 1 ]the means of protection used will be assessed by questionnaire
Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients [ Time Frame: Day 1 ]The feeling of fear and the impact on stigmatization will be assessed by questionnaire
Sociodemographic factors and lifestyle habits [ Time Frame: Day 1 ]Sociodemographic factors and lifestyle habits will be assessed by questionnaire Feeling of information on the part of companies / establishments / governments [ Time Frame: Day 1 ]The feeling of information will be assessed by questionnaire
Means of protection [ Time Frame: Day 1 ]the means of protection used will be assessed by questionnaire
Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients [ Time Frame: Day 1 ]The feeling of fear and the impact on stigmatization will be assessed by questionnaire
Sociodemographic factors and lifestyle habits [ Time Frame: Day 1 ]Sociodemographic factors and lifestyle habits will be assessed by questionnaire Means of protection [ Time Frame: Day 1 ]the means of protection used will be assessed by questionnaire
Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients [ Time Frame: Day 1 ]The feeling of fear and the impact on stigmatization will be assessed by questionnaire
Sociodemographic factors and lifestyle habits [ Time Frame: Day 1 ]Sociodemographic factors and lifestyle habits will be assessed by questionnaire Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients [ Time Frame: Day 1 ]The feeling of fear and the impact on stigmatization will be assessed by questionnaire
Sociodemographic factors and lifestyle habits [ Time Frame: Day 1 ]Sociodemographic factors and lifestyle habits will be assessed by questionnaire Sociodemographic factors and lifestyle habits [ Time Frame: Day 1 ]Sociodemographic factors and lifestyle habits will be assessed by questionnaire",50000
133,Recruiting,"Phase 2
Phase 3",All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04322344,"Mortality rate [ Time Frame: up to 30 days ]All cause mortality
Clinical status evaluated in agreement with guidelines [ Time Frame: up to 30 days ]mild type：no No symptoms, Radiological examination: no pneumonia; possible mild increase in C-reactive portein 2, moderate type: fever, cough, or other respiratory symptoms. Radiological examination: pneumonia, SpO2＞93% without oxygen inhalation ; increase in C reactive protein, 3: severe type: a. Rate ≥30bpm；b. Pulse Oxygen Saturation (SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS Clinical status evaluated in agreement with guidelines [ Time Frame: up to 30 days ]mild type：no No symptoms, Radiological examination: no pneumonia; possible mild increase in C-reactive portein 2, moderate type: fever, cough, or other respiratory symptoms. Radiological examination: pneumonia, SpO2＞93% without oxygen inhalation ; increase in C reactive protein, 3: severe type: a. Rate ≥30bpm；b. Pulse Oxygen Saturation (SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS","The differences in oxygen intake methods [ Time Frame: up to 30 days ]Pulse Oxygen Saturation(SpO2)＞93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）
Time of hospitalization (days) [ Time Frame: up to 30 days ]days
Time of hospitalization in intensive care units [ Time Frame: up to 30 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge Time of hospitalization (days) [ Time Frame: up to 30 days ]days
Time of hospitalization in intensive care units [ Time Frame: up to 30 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge Time of hospitalization in intensive care units [ Time Frame: up to 30 days ]days
Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge",120
134,Not yet recruiting,Phase 2,All,"18 Years to 99 Years   (Adult, Older Adult)",NCT04312243,COVID-19 diagnosis [ Time Frame: 28 days ]Percentage of subjects with COVID-19 diagnosis,Positive SARS-CoV-2 rt-PCR test [ Time Frame: 28 days ]Percentage of subjects with a positive test in the two groups,460
135,Not yet recruiting,,All,"18 Years to 100 Years   (Adult, Older Adult)",NCT04324684,"Hypertension Obesity and/or type 2 diabetes Cardiovascular disease Chronic obstructive lung disease None of the above diseases Other endpoints are liver, kidney or multiorgan failure, cardiac failure, the efficacy of different pharmaceutical treatment against Covid-19 and the development of predictors and biomarkers of the severity of Covid-19 infection.","Zhou F, Yu T, Du R et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020; (published online March 9 https://doi.org/10.1016/S0140-6736(20)30566-3). Guan W, Ni Z,Hu Y et al. Clinical characteristics of coronavirus disease 2019 in China.
N Engl J Med. 2020; (published online Feb 28.) Bornstein S, Delan R, Hopkins D, Mingrone G, Boehm B. Endocrine and metabolic link to Corona Virus infection. Nature Reviews Endocrinology 2020, in press. Masters, S.L.; Dunne, A.; Subramanian, S.L.; Hull, R.L.; Tannahill, G.M.; Sharp, F.A.; Becker, C.; Franchi, L.; Yoshihara, E.; Chen, Z.; et al. Activation of the NLRP3 inflammasome by islet amyloid polypeptide provides a mechanism for enhanced IL-1β in type 2 diabetes. Nat. Immunol. 2010, 11, 897-904. Qu D, Liu J, Lau CW, Huang Y. IL-6 in diabetes and cardiovascular complications. Br J Pharmacol. 2014;171: 3595-603.",198
136,Not yet recruiting,Not Applicable,All,18 Years to 60 Years   (Adult),NCT04306055,Differences of attitude about blood donation towards different questionnaires [ Time Frame: 1 day ]Compare participants' intention of blood donation after they read different information in the questionnaire.,Rates of blood donation during 3 weeks [ Time Frame: 3 weeks ]Blood donation rate of 3 groups will be followed,1500
137,Not yet recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04320732,Hospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease Hospitalized patients without COVID-19 Healthcare personal or other groups with an increased risk of COVID-19 Healthy volunteers,Rate of COVID-19 infection [ Time Frame: 1 year ]Diagnosed with serology or direct viral detection,50000
138,"Active, not recruiting",,All,"18 Years and older   (Adult, Older Adult)",NCT04322786,Incidence of influenza [ Time Frame: Jan 1st 1998 - May 31st 2016 ],We identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.,1302508
139,Not yet recruiting,Not Applicable,All,"18 Years and older   (Adult, Older Adult)",NCT04296643,RT-PCR confirmed COVID-19 infection [ Time Frame: 6 months ]Number of participants with RT-PCR confirmed COVID-19 infection,"Acute respiratory illness [ Time Frame: 6 months ]Number of participants with acute respiratory illness
Absenteeism [ Time Frame: 6 months ]Number of participants with absenteeism
Lower respiratory infection [ Time Frame: 6 months ]Number of participants with lower respiratory infection
Pneumonia [ Time Frame: 6 months ]Number of participants with pneumonia
ICU admission [ Time Frame: 6 months ]Number of participants with ICU admission
Mechanical ventilation [ Time Frame: 6 months ]Number of participants needing mechanical ventilation
Death [ Time Frame: 6 months ]Number of participants that died Absenteeism [ Time Frame: 6 months ]Number of participants with absenteeism
Lower respiratory infection [ Time Frame: 6 months ]Number of participants with lower respiratory infection
Pneumonia [ Time Frame: 6 months ]Number of participants with pneumonia
ICU admission [ Time Frame: 6 months ]Number of participants with ICU admission
Mechanical ventilation [ Time Frame: 6 months ]Number of participants needing mechanical ventilation
Death [ Time Frame: 6 months ]Number of participants that died Lower respiratory infection [ Time Frame: 6 months ]Number of participants with lower respiratory infection
Pneumonia [ Time Frame: 6 months ]Number of participants with pneumonia
ICU admission [ Time Frame: 6 months ]Number of participants with ICU admission
Mechanical ventilation [ Time Frame: 6 months ]Number of participants needing mechanical ventilation
Death [ Time Frame: 6 months ]Number of participants that died Pneumonia [ Time Frame: 6 months ]Number of participants with pneumonia
ICU admission [ Time Frame: 6 months ]Number of participants with ICU admission
Mechanical ventilation [ Time Frame: 6 months ]Number of participants needing mechanical ventilation
Death [ Time Frame: 6 months ]Number of participants that died ICU admission [ Time Frame: 6 months ]Number of participants with ICU admission
Mechanical ventilation [ Time Frame: 6 months ]Number of participants needing mechanical ventilation
Death [ Time Frame: 6 months ]Number of participants that died Mechanical ventilation [ Time Frame: 6 months ]Number of participants needing mechanical ventilation
Death [ Time Frame: 6 months ]Number of participants that died Death [ Time Frame: 6 months ]Number of participants that died",576
140,Recruiting,,Female,"Child, Adult, Older Adult",NCT04319016,"Other: pregnant women with laboratory-confirmed 2019-n-CoV
Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV were included in a merged database","Maternal and perinatal outcomes [ Time Frame: at the time of delivery ]different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission",20
141,Completed,,All,"Child, Adult, Older Adult",NCT04302688,"First we collect the medical records, according to the time sequence, the patients were divided into two groups, one is the model group, and the other is the validate group. Responsible for the risk factor of regression equation according to the model. The patients were divided into three groups according to their total score of risk responsibility. Compared with SEPSIS and CURB-65 grading system with the grading system we established.","survival status [ Time Frame: 10 December 2019 to 10 February 2020 ]survival status as of February 24, 2020",669
142,Recruiting,,All,up to 28 Days   (Child),NCT04279899,"The death of newborns with COVID-19 [ Time Frame: The date of discharge，an average of 4 weeks after the admission ]
The SARS-CoV-2 infection of neonates born to mothers with COVID-19 [ Time Frame: within 7days after the admission ]Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee. The SARS-CoV-2 infection of neonates born to mothers with COVID-19 [ Time Frame: within 7days after the admission ]Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.","The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19 [ Time Frame: Infants ( ≥35 weeks）are at 6 months after birth;Infants（＜ 35weeks） are at a corrected age of 6 months. ]The standardized DDST consists of 104 items and covers four areas of development: (a) personal/social, (b) fine motor/adaptive, (c) language, and (d) gross motor. In the present study, three trained professionals examined the children. The results of the DDST could be normal (no delays), suspect (2 or more caution items and/or 1 or more delays), abnormal (2 or more delays) or untestable (refusal of one or more items completely to the left of the age line or more than one item intersected by the age line in the 75-90% area). The children with suspect or abnormal results were retested 2 or 3 weeks later.
The small for gestational age newborns in the neonates born to mothers with COVID-19 [ Time Frame: at birth ]The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).
The preterm delivery of neonates born to mothers with COVID-19 [ Time Frame: at birth ]The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days
The disease severity of neonates with COVID-19 [ Time Frame: through study completion, estimated an average of 2 weeks ]Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese The small for gestational age newborns in the neonates born to mothers with COVID-19 [ Time Frame: at birth ]The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).
The preterm delivery of neonates born to mothers with COVID-19 [ Time Frame: at birth ]The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days
The disease severity of neonates with COVID-19 [ Time Frame: through study completion, estimated an average of 2 weeks ]Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese The preterm delivery of neonates born to mothers with COVID-19 [ Time Frame: at birth ]The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days
The disease severity of neonates with COVID-19 [ Time Frame: through study completion, estimated an average of 2 weeks ]Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese The disease severity of neonates with COVID-19 [ Time Frame: through study completion, estimated an average of 2 weeks ]Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese",100
143,Withdrawn,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04290871,SARS-free patients at 14 days [ Time Frame: 14 days since beginning of treatment ]Percentage of patients that have a PaO2/FiO2 ratio steadily > 300 in ambient air,"Survival at 28 days [ Time Frame: 28 days ]
Survival at 90 days [ Time Frame: 90 days ]
SARS-free days at 28 days [ Time Frame: 28 days ]Composite outcome in which: Death=0, Days of treatment =1
SARS -free days at 90 days [ Time Frame: 90 days ]Composite outcome in which: Death=0, Days of treatment =1
Renal Replacement Therapy [ Time Frame: 28 days ]Incidence
Liver Failure [ Time Frame: 28 days ]Incidence
Mechanical Support of Circulation [ Time Frame: 28 days ]Incidence of patients requiring VA-ECMO, LVAD, IABP
PaO2/FiO2 ratio in ambient air [ Time Frame: daily for 28 days ]In ambient air if possible Survival at 90 days [ Time Frame: 90 days ]
SARS-free days at 28 days [ Time Frame: 28 days ]Composite outcome in which: Death=0, Days of treatment =1
SARS -free days at 90 days [ Time Frame: 90 days ]Composite outcome in which: Death=0, Days of treatment =1
Renal Replacement Therapy [ Time Frame: 28 days ]Incidence
Liver Failure [ Time Frame: 28 days ]Incidence
Mechanical Support of Circulation [ Time Frame: 28 days ]Incidence of patients requiring VA-ECMO, LVAD, IABP
PaO2/FiO2 ratio in ambient air [ Time Frame: daily for 28 days ]In ambient air if possible SARS-free days at 28 days [ Time Frame: 28 days ]Composite outcome in which: Death=0, Days of treatment =1
SARS -free days at 90 days [ Time Frame: 90 days ]Composite outcome in which: Death=0, Days of treatment =1
Renal Replacement Therapy [ Time Frame: 28 days ]Incidence
Liver Failure [ Time Frame: 28 days ]Incidence
Mechanical Support of Circulation [ Time Frame: 28 days ]Incidence of patients requiring VA-ECMO, LVAD, IABP
PaO2/FiO2 ratio in ambient air [ Time Frame: daily for 28 days ]In ambient air if possible SARS -free days at 90 days [ Time Frame: 90 days ]Composite outcome in which: Death=0, Days of treatment =1
Renal Replacement Therapy [ Time Frame: 28 days ]Incidence
Liver Failure [ Time Frame: 28 days ]Incidence
Mechanical Support of Circulation [ Time Frame: 28 days ]Incidence of patients requiring VA-ECMO, LVAD, IABP
PaO2/FiO2 ratio in ambient air [ Time Frame: daily for 28 days ]In ambient air if possible Renal Replacement Therapy [ Time Frame: 28 days ]Incidence
Liver Failure [ Time Frame: 28 days ]Incidence
Mechanical Support of Circulation [ Time Frame: 28 days ]Incidence of patients requiring VA-ECMO, LVAD, IABP
PaO2/FiO2 ratio in ambient air [ Time Frame: daily for 28 days ]In ambient air if possible Liver Failure [ Time Frame: 28 days ]Incidence
Mechanical Support of Circulation [ Time Frame: 28 days ]Incidence of patients requiring VA-ECMO, LVAD, IABP
PaO2/FiO2 ratio in ambient air [ Time Frame: daily for 28 days ]In ambient air if possible Mechanical Support of Circulation [ Time Frame: 28 days ]Incidence of patients requiring VA-ECMO, LVAD, IABP
PaO2/FiO2 ratio in ambient air [ Time Frame: daily for 28 days ]In ambient air if possible PaO2/FiO2 ratio in ambient air [ Time Frame: daily for 28 days ]In ambient air if possible",0
144,Recruiting,,All,"Child, Adult, Older Adult",NCT04292340,"The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1 [ Time Frame: 1 day after receiving plasma transmission ]The SARS-CoV-2 nuclei acid was quantified using RT-PCR
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after receiving plasma transmission ]
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after receiving plasma transmission ]
Numbers of participants with different Clinical outcomes [ Time Frame: From receiving plasma transmission to 4 weeks ]Clinical outcomes include death, critical illness, recovery The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after receiving plasma transmission ]
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after receiving plasma transmission ]
Numbers of participants with different Clinical outcomes [ Time Frame: From receiving plasma transmission to 4 weeks ]Clinical outcomes include death, critical illness, recovery The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after receiving plasma transmission ]
Numbers of participants with different Clinical outcomes [ Time Frame: From receiving plasma transmission to 4 weeks ]Clinical outcomes include death, critical illness, recovery Numbers of participants with different Clinical outcomes [ Time Frame: From receiving plasma transmission to 4 weeks ]Clinical outcomes include death, critical illness, recovery",Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 4 weeks after receiving plasma transmission ],15
145,Not yet recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04324047,"Survival [ Time Frame: 14 days ]Overall Survival
WHO progression scale COVID 19 [ Time Frame: 14 days ]Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10 WHO progression scale COVID 19 [ Time Frame: 14 days ]Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10","Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours and/or CT Scan prior to randomization (Following typical radiological findings (ground glass abnormalities, and absence of lymphadenopathy, pleural effusion, pulmonary nodules, lung cavitation) Hospitalized patients Illness of any duration and severity (mild, moderate, severe, critical, see annexe 1), with symptoms (fever, cough, respiratory difficulties, shortness of breath), and at least one of the following: Radiographic infiltrates by imaging (CT scan) Clinical assessment (evidence of rales/crackles on exam or respiratory rate >25/min) AND SpO2≤94% on room air SpO2≤97 % with O2 > 5L/min or Respiratory rate>=30/min Requiring mechanical ventilation With any comorbidities (TBD such as acute kidney injury, cardiovascular condition, pulmonary disease, obesity, high blood pressure, diabetes, chronic kidney diseases, haematological diseases, sickle cell diseases, autoimmune and auto-inflammatory, pregnant women, HIV infected, etc) Male or female adult ≥ 18 years of age at time of enrolment Patients must be able and willing to comply with study visits and procedures. Patient agrees to the collection of oropharyngeal and nasal swabs and venous blood per protocol Written informed consent provided by the patient or alternatively by next-of-kin prior to any protocol-specific procedures.",1000
146,Recruiting,,Female,18 Years to 50 Years   (Adult),NCT04315870,"Other: pregnant women with laboratory-confirmed 2019-n-CoV
Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV were included in a merged database","Maternal and perinatal outcomes [ Time Frame: during gestation and at the time of delivery of the baby ]different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission",20
147,Not yet recruiting,Phase 4,All,"Child, Adult, Older Adult",NCT04322396,Number of days alive and discharged from hospital within 14 days [ Time Frame: 14 days ],"Categorization of hospitalization status [ Time Frame: 14 days ]The patient will becategorized into one of the following 8 categories depending on status of their hospitalization:

Dead (yes/no)
Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no)
Hospitalized and receiving Non-invasive ventilation or ""high-flow oxygen device"" (yes/no)
Hospitalized and given oxygen supplements different from (2) and (3) (yes/no)
Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no)
Hospitalized for observation (yes/no)
Discharged from hospital with restriction of activity level (yes/no)
Discharged from hospital without any restrictions of activity level (yes/no)

Only one category can be ""yes"".
Admitted to intensive care unit, if admitted to ICU then length of stay [ Time Frame: 14 days ]
Have used Non-invasive ventilation (NIV) during hospitalization [ Time Frame: 14 days ]
Mortality [ Time Frame: 30 days ]
Length of hospitalization [ Time Frame: 14 days ]
Days alive and discharged from hospital [ Time Frame: 30 days ]
Mortality [ Time Frame: 90 days ]
Mortality [ Time Frame: 365 days ]
Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or ""high-flow oxygen device"" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Admitted to intensive care unit, if admitted to ICU then length of stay [ Time Frame: 14 days ]
Have used Non-invasive ventilation (NIV) during hospitalization [ Time Frame: 14 days ]
Mortality [ Time Frame: 30 days ]
Length of hospitalization [ Time Frame: 14 days ]
Days alive and discharged from hospital [ Time Frame: 30 days ]
Mortality [ Time Frame: 90 days ]
Mortality [ Time Frame: 365 days ]
Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Have used Non-invasive ventilation (NIV) during hospitalization [ Time Frame: 14 days ]
Mortality [ Time Frame: 30 days ]
Length of hospitalization [ Time Frame: 14 days ]
Days alive and discharged from hospital [ Time Frame: 30 days ]
Mortality [ Time Frame: 90 days ]
Mortality [ Time Frame: 365 days ]
Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Mortality [ Time Frame: 30 days ]
Length of hospitalization [ Time Frame: 14 days ]
Days alive and discharged from hospital [ Time Frame: 30 days ]
Mortality [ Time Frame: 90 days ]
Mortality [ Time Frame: 365 days ]
Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Length of hospitalization [ Time Frame: 14 days ]
Days alive and discharged from hospital [ Time Frame: 30 days ]
Mortality [ Time Frame: 90 days ]
Mortality [ Time Frame: 365 days ]
Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Days alive and discharged from hospital [ Time Frame: 30 days ]
Mortality [ Time Frame: 90 days ]
Mortality [ Time Frame: 365 days ]
Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Mortality [ Time Frame: 90 days ]
Mortality [ Time Frame: 365 days ]
Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Mortality [ Time Frame: 365 days ]
Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Number of readmissions (all causes) [ Time Frame: 30 days ]
Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Number of days using non-invasive ventilation (NIV) [ Time Frame: 14 days ]
Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Change in patient's oxygen partial pressure [ Time Frame: 4 days ]Delta PaO2 measured in arterial puncture
Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]Delta PaCO2 measured in arterial puncture
Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Level of pH in blood [ Time Frame: 4 days ]pH measured in arterial puncture
Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ] Time for no oxygen supplement (or regular oxygen supplement ""LTOT"") [ Time Frame: 14 days ]",226
148,Not yet recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04274322,"28-day all cause mortality [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]","All cause infection [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
The rate of complications [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
Length of ICU stay [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
Duration of mechanical ventilation [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ] The rate of complications [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
Length of ICU stay [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
Duration of mechanical ventilation [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ] Length of ICU stay [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
Duration of mechanical ventilation [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ] Duration of mechanical ventilation [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]",100
149,Not yet recruiting,"Phase 2
Phase 3",All,"18 Years and older   (Adult, Older Adult)",NCT04324073,"Survival without needs of ventilator utilization at day 14. [ Time Frame: 14 days ]Survival without needs of ventilator utilization (including Non invasive ventilation) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NVI), or death. New Do Not Resuscitate (DNR) order will be considered as an event at the date of the DNR.
WHO progression scale <=5 at day 4 [ Time Frame: 4 days ]WHO progression scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 [ Time Frame: 14 days ]Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Death or DNR order will be considered as a competing event.
WHO progression scale <=7 at day 4 [ Time Frame: 4 days ]WHO progression scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10 WHO progression scale <=5 at day 4 [ Time Frame: 4 days ]WHO progression scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 [ Time Frame: 14 days ]Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Death or DNR order will be considered as a competing event.
WHO progression scale <=7 at day 4 [ Time Frame: 4 days ]WHO progression scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10 Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 [ Time Frame: 14 days ]Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Death or DNR order will be considered as a competing event.
WHO progression scale <=7 at day 4 [ Time Frame: 4 days ]WHO progression scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10 WHO progression scale <=7 at day 4 [ Time Frame: 4 days ]WHO progression scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10","WHO progression scale [ Time Frame: 7 and 14 days ]WHO progression scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Survival [ Time Frame: 14, 28 and 90 days ]Overall survival
28-day ventilator free-days [ Time Frame: 28 days ]
respiratory acidosis at day 4 [ Time Frame: 4 days ]arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
PaO2/FiO2 ratio [ Time Frame: day 1 to day 14 ]evolution of PaO2/FiO2 ratio
time to oxygen supply independency [ Time Frame: 14 days ]time to oxygen supply independency
duration of hospitalization [ Time Frame: 90 days ]duration of hospitalization
time to negative viral excretion [ Time Frame: 90 days ]time to negative viral excretion
time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge Survival [ Time Frame: 14, 28 and 90 days ]Overall survival
28-day ventilator free-days [ Time Frame: 28 days ]
respiratory acidosis at day 4 [ Time Frame: 4 days ]arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
PaO2/FiO2 ratio [ Time Frame: day 1 to day 14 ]evolution of PaO2/FiO2 ratio
time to oxygen supply independency [ Time Frame: 14 days ]time to oxygen supply independency
duration of hospitalization [ Time Frame: 90 days ]duration of hospitalization
time to negative viral excretion [ Time Frame: 90 days ]time to negative viral excretion
time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge 28-day ventilator free-days [ Time Frame: 28 days ]
respiratory acidosis at day 4 [ Time Frame: 4 days ]arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
PaO2/FiO2 ratio [ Time Frame: day 1 to day 14 ]evolution of PaO2/FiO2 ratio
time to oxygen supply independency [ Time Frame: 14 days ]time to oxygen supply independency
duration of hospitalization [ Time Frame: 90 days ]duration of hospitalization
time to negative viral excretion [ Time Frame: 90 days ]time to negative viral excretion
time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge respiratory acidosis at day 4 [ Time Frame: 4 days ]arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
PaO2/FiO2 ratio [ Time Frame: day 1 to day 14 ]evolution of PaO2/FiO2 ratio
time to oxygen supply independency [ Time Frame: 14 days ]time to oxygen supply independency
duration of hospitalization [ Time Frame: 90 days ]duration of hospitalization
time to negative viral excretion [ Time Frame: 90 days ]time to negative viral excretion
time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge PaO2/FiO2 ratio [ Time Frame: day 1 to day 14 ]evolution of PaO2/FiO2 ratio
time to oxygen supply independency [ Time Frame: 14 days ]time to oxygen supply independency
duration of hospitalization [ Time Frame: 90 days ]duration of hospitalization
time to negative viral excretion [ Time Frame: 90 days ]time to negative viral excretion
time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge time to oxygen supply independency [ Time Frame: 14 days ]time to oxygen supply independency
duration of hospitalization [ Time Frame: 90 days ]duration of hospitalization
time to negative viral excretion [ Time Frame: 90 days ]time to negative viral excretion
time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge duration of hospitalization [ Time Frame: 90 days ]duration of hospitalization
time to negative viral excretion [ Time Frame: 90 days ]time to negative viral excretion
time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge time to negative viral excretion [ Time Frame: 90 days ]time to negative viral excretion
time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge time to ICU discharge [ Time Frame: 90 days ]time to ICU discharge
time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge time to hospital discharge [ Time Frame: 90 days ]time to hospital discharge",180
150,Not yet recruiting,Early Phase 1,All,"18 Years and older   (Adult, Older Adult)",NCT04293887,"The incidence of side effects [ Time Frame: Within 14 days after enrollment ]dyspnea
The incidence of side effects [ Time Frame: Within 14 days after enrollment ]SPO2≤94%
The incidence of side effects [ Time Frame: Within 14 days after enrollment ]respiratory rate ≥24 breaths/min in oxygen state) The incidence of side effects [ Time Frame: Within 14 days after enrollment ]SPO2≤94%
The incidence of side effects [ Time Frame: Within 14 days after enrollment ]respiratory rate ≥24 breaths/min in oxygen state) The incidence of side effects [ Time Frame: Within 14 days after enrollment ]respiratory rate ≥24 breaths/min in oxygen state)","Time from patient enrollment to clinical remission [ Time Frame: Within 14 days after enrollment ]the patient had a normal body temperature of > for 24 hours (without taking antipyretic drugs or hormones) without self-consciousness Dyspnea or reduced dyspnea;
Proportion of patients with normal body [ Time Frame: Within 14 days after enrollment ]Proportion of patients with normal body
Proportion of patients without dyspnea [ Time Frame: Within 14 days after enrollment ]Proportion of patients without dyspnea
Proportion of patients without cough [ Time Frame: Within 14 days after enrollment ]Proportion of patients without cough
Proportion [ Time Frame: Within 14 days after enrollment ]Proportion of patients without oxygen treatment
The negative conversion rate of new coronavirus nucleic acid [ Time Frame: Within 14 days after enrollment ]The negative conversion rate of new coronavirus nucleic acid
Proportion [ Time Frame: within 28 days after enrollment ]Proportion of patients hospitalized/hospitalized in ICU
Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events. Proportion of patients with normal body [ Time Frame: Within 14 days after enrollment ]Proportion of patients with normal body
Proportion of patients without dyspnea [ Time Frame: Within 14 days after enrollment ]Proportion of patients without dyspnea
Proportion of patients without cough [ Time Frame: Within 14 days after enrollment ]Proportion of patients without cough
Proportion [ Time Frame: Within 14 days after enrollment ]Proportion of patients without oxygen treatment
The negative conversion rate of new coronavirus nucleic acid [ Time Frame: Within 14 days after enrollment ]The negative conversion rate of new coronavirus nucleic acid
Proportion [ Time Frame: within 28 days after enrollment ]Proportion of patients hospitalized/hospitalized in ICU
Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events. Proportion of patients without dyspnea [ Time Frame: Within 14 days after enrollment ]Proportion of patients without dyspnea
Proportion of patients without cough [ Time Frame: Within 14 days after enrollment ]Proportion of patients without cough
Proportion [ Time Frame: Within 14 days after enrollment ]Proportion of patients without oxygen treatment
The negative conversion rate of new coronavirus nucleic acid [ Time Frame: Within 14 days after enrollment ]The negative conversion rate of new coronavirus nucleic acid
Proportion [ Time Frame: within 28 days after enrollment ]Proportion of patients hospitalized/hospitalized in ICU
Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events. Proportion of patients without cough [ Time Frame: Within 14 days after enrollment ]Proportion of patients without cough
Proportion [ Time Frame: Within 14 days after enrollment ]Proportion of patients without oxygen treatment
The negative conversion rate of new coronavirus nucleic acid [ Time Frame: Within 14 days after enrollment ]The negative conversion rate of new coronavirus nucleic acid
Proportion [ Time Frame: within 28 days after enrollment ]Proportion of patients hospitalized/hospitalized in ICU
Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events. Proportion [ Time Frame: Within 14 days after enrollment ]Proportion of patients without oxygen treatment
The negative conversion rate of new coronavirus nucleic acid [ Time Frame: Within 14 days after enrollment ]The negative conversion rate of new coronavirus nucleic acid
Proportion [ Time Frame: within 28 days after enrollment ]Proportion of patients hospitalized/hospitalized in ICU
Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events. The negative conversion rate of new coronavirus nucleic acid [ Time Frame: Within 14 days after enrollment ]The negative conversion rate of new coronavirus nucleic acid
Proportion [ Time Frame: within 28 days after enrollment ]Proportion of patients hospitalized/hospitalized in ICU
Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events. Proportion [ Time Frame: within 28 days after enrollment ]Proportion of patients hospitalized/hospitalized in ICU
Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events. Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events.",328
151,Recruiting,,All,"Child, Adult, Older Adult",NCT04279795,"Positive rate of 2019 Novel Coronavirus RNA [ Time Frame: 28 days ]rate of positive results of detection 2019 Novel Coronavirus nucleic acid from urine, blood, anal swabs and pharyngeal swabs samples",Survival rate [ Time Frame: 28 days ]If the patient will survive after comprehensive treatment,20
152,Recruiting,,All,"Child, Adult, Older Adult",NCT04279782,Survival rate [ Time Frame: 28 days ]If the patient will survive after comprehensive treatment,"Chest computed tomography [ Time Frame: 28 days ]Images of chest computed tomography are obtained to find out the changes in the course of treatment
Recovery Time [ Time Frame: 28 days ]Time for recovery from admission to discharged
Depression evaluation [ Time Frame: 28 days ]A self-rating depression scale (SCL-90) will be finished from patients and medical staff. There are 90 questions. Each question scores from 1 to 5. Minimum score is 90, maximun score is 450. High scores indicate poor condition. Recovery Time [ Time Frame: 28 days ]Time for recovery from admission to discharged
Depression evaluation [ Time Frame: 28 days ]A self-rating depression scale (SCL-90) will be finished from patients and medical staff. There are 90 questions. Each question scores from 1 to 5. Minimum score is 90, maximun score is 450. High scores indicate poor condition. Depression evaluation [ Time Frame: 28 days ]A self-rating depression scale (SCL-90) will be finished from patients and medical staff. There are 90 questions. Each question scores from 1 to 5. Minimum score is 90, maximun score is 450. High scores indicate poor condition.",100
153,"Active, not recruiting",,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04292327,"Mortality [ Time Frame: 28 day ]The mortality of COVID-19 in 28 days
The time interval of Nucleic acid detection become negative [ Time Frame: 28 day ]The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative. The time interval of Nucleic acid detection become negative [ Time Frame: 28 day ]The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.","2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR. Older than 18 years old and younger than 75 years old. Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)",400
154,Recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04318366,"Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response [ Time Frame: Hospital stay (2-3 weeks) ]Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response",Patients admitted to hospital with biological samples positive for SARS-CoV-2 Patients admitted to hospital with negative test but clinical and radiological characteristics highly suggestive of SARS-CoV-2 disease Patients discharged from emergency department with biological samples positive for SARS-CoV-2,1000
155,Not yet recruiting,Not Applicable,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04261907,"The incidence of composite adverse outcome [ Time Frame: 14 days ]Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.","Time to recovery [ Time Frame: 14 days ]Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA.
Rate of no fever [ Time Frame: 14 days ]
Rate of no cough [ Time Frame: 14 days ]
Rate of no dyspnea [ Time Frame: 14 days ]
Rate of no requring supplemental oxygen [ Time Frame: 14 days ]
Rate of undectable viral RNA [ Time Frame: 14 days ]
Rate of mechanical ventilation [ Time Frame: 14 days ]
Rate of ICU admission [ Time Frame: 14 days ]
Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ] Rate of no fever [ Time Frame: 14 days ]
Rate of no cough [ Time Frame: 14 days ]
Rate of no dyspnea [ Time Frame: 14 days ]
Rate of no requring supplemental oxygen [ Time Frame: 14 days ]
Rate of undectable viral RNA [ Time Frame: 14 days ]
Rate of mechanical ventilation [ Time Frame: 14 days ]
Rate of ICU admission [ Time Frame: 14 days ]
Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ] Rate of no cough [ Time Frame: 14 days ]
Rate of no dyspnea [ Time Frame: 14 days ]
Rate of no requring supplemental oxygen [ Time Frame: 14 days ]
Rate of undectable viral RNA [ Time Frame: 14 days ]
Rate of mechanical ventilation [ Time Frame: 14 days ]
Rate of ICU admission [ Time Frame: 14 days ]
Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ] Rate of no dyspnea [ Time Frame: 14 days ]
Rate of no requring supplemental oxygen [ Time Frame: 14 days ]
Rate of undectable viral RNA [ Time Frame: 14 days ]
Rate of mechanical ventilation [ Time Frame: 14 days ]
Rate of ICU admission [ Time Frame: 14 days ]
Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ] Rate of no requring supplemental oxygen [ Time Frame: 14 days ]
Rate of undectable viral RNA [ Time Frame: 14 days ]
Rate of mechanical ventilation [ Time Frame: 14 days ]
Rate of ICU admission [ Time Frame: 14 days ]
Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ] Rate of undectable viral RNA [ Time Frame: 14 days ]
Rate of mechanical ventilation [ Time Frame: 14 days ]
Rate of ICU admission [ Time Frame: 14 days ]
Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ] Rate of mechanical ventilation [ Time Frame: 14 days ]
Rate of ICU admission [ Time Frame: 14 days ]
Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ] Rate of ICU admission [ Time Frame: 14 days ]
Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ] Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ]",160
156,Recruiting,Phase 2,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04269525,Oxygenation index [ Time Frame: on the day 14 after enrollment ]partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2),"28 day mortality [ Time Frame: on the day 28 after enrollment ]whether the patient survives
Hospital stay [ Time Frame: up to 6 months ]days of the patients in hospital
2019-nCoV nucleic acid test [ Time Frame: on the day 7,14,28 after enrollment ]whether or not the 2019-nCoV nucleic acid test is positive
Improvement of lung imaging examinations [ Time Frame: on the day 7,14,28 after enrollment ]whether lung imaging examinations show the improvement of the pneumonia
White blood cell count [ Time Frame: on the day 7,14,28 after enrollment ]counts of white blood cell in a litre of blood
Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]counts of lymphocyte in a litre (L) of blood
Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]percentage of lymphocyte in white blood cell
Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]procalcitonin in microgram(ug)/L
interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L Hospital stay [ Time Frame: up to 6 months ]days of the patients in hospital
2019-nCoV nucleic acid test [ Time Frame: on the day 7,14,28 after enrollment ]whether or not the 2019-nCoV nucleic acid test is positive
Improvement of lung imaging examinations [ Time Frame: on the day 7,14,28 after enrollment ]whether lung imaging examinations show the improvement of the pneumonia
White blood cell count [ Time Frame: on the day 7,14,28 after enrollment ]counts of white blood cell in a litre of blood
Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]counts of lymphocyte in a litre (L) of blood
Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]percentage of lymphocyte in white blood cell
Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]procalcitonin in microgram(ug)/L
interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L 2019-nCoV nucleic acid test [ Time Frame: on the day 7,14,28 after enrollment ]whether or not the 2019-nCoV nucleic acid test is positive
Improvement of lung imaging examinations [ Time Frame: on the day 7,14,28 after enrollment ]whether lung imaging examinations show the improvement of the pneumonia
White blood cell count [ Time Frame: on the day 7,14,28 after enrollment ]counts of white blood cell in a litre of blood
Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]counts of lymphocyte in a litre (L) of blood
Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]percentage of lymphocyte in white blood cell
Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]procalcitonin in microgram(ug)/L
interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L Improvement of lung imaging examinations [ Time Frame: on the day 7,14,28 after enrollment ]whether lung imaging examinations show the improvement of the pneumonia
White blood cell count [ Time Frame: on the day 7,14,28 after enrollment ]counts of white blood cell in a litre of blood
Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]counts of lymphocyte in a litre (L) of blood
Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]percentage of lymphocyte in white blood cell
Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]procalcitonin in microgram(ug)/L
interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L White blood cell count [ Time Frame: on the day 7,14,28 after enrollment ]counts of white blood cell in a litre of blood
Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]counts of lymphocyte in a litre (L) of blood
Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]percentage of lymphocyte in white blood cell
Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]procalcitonin in microgram(ug)/L
interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L Lymphocyte count [ Time Frame: on the day 7,14,28 after enrollment ]counts of lymphocyte in a litre (L) of blood
Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]percentage of lymphocyte in white blood cell
Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]procalcitonin in microgram(ug)/L
interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L Lymphocyte percentage [ Time Frame: on the day 7,14,28 after enrollment ]percentage of lymphocyte in white blood cell
Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]procalcitonin in microgram(ug)/L
interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L Procalcitonin [ Time Frame: on the day 7,14,28 after enrollment ]procalcitonin in microgram(ug)/L
interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L interleukin(IL)-2 [ Time Frame: on the day 7,14,28 after enrollment ]IL-2 in picogram(pg)/millilitre(mL)
IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L IL-4 [ Time Frame: on the day 7,14,28 after enrollment ]IL-4 in pg/mL
IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L IL-6 [ Time Frame: on the day 7,14,28 after enrollment ]IL-6 in pg/mL
IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L IL-8 [ Time Frame: on the day 7,14,28 after enrollment ]IL-8 in pg/mL
IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L IL-10 [ Time Frame: on the day 7,14,28 after enrollment ]IL-10 in pg/mL
tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L tumor necrosis factor(TNF)-α [ Time Frame: on the day 7,14,28 after enrollment ]TNF-α in nanogram(ng)/L
γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L γ-interferon(IFN) [ Time Frame: on the day 7,14,28 after enrollment ]γ-IFN in a thousand unit (KU)/L",10
157,Recruiting,Phase 2,All,"18 Years to 99 Years   (Adult, Older Adult)",NCT04306393,"Change of arterial oxygenation at 48 hours from enrollment [ Time Frame: 48 hours ]Difference within groups in terms of PaO2/FiO2 ratio. If a patient dies during the first 48 hours of treatment, the last available blood gas analysis will be used.","Time to reach normoxemia during the first 28 days after enrollment [ Time Frame: 28 days ]Time to recover gas exchange to a PaO2/FiO2 =/> 300 for at least 24 hours during the first 28 days after enrollment, within each group and comparison between groups. If the patient dies before day 28, the patient will be considered as ""never recovered"".
Proportion of SARS-nCoV-2 free patients during the first 28 days after enrollment [ Time Frame: 28 days ]Daily proportion of patients with a PaO2/FiO2 ratio > 300 for at least 24 hours within each group and comparison between groups. If a patient dies before day 28, the patient will be considered as ""never recovered"".
Survival at 28 days from enrollment [ Time Frame: 28 days ]Proportion of patients surviving at 28 days within each group and comparison between groups.
Survival at 90 days from enrollment [ Time Frame: 90 days ]Proportion of patients surviving at 90 days within each group and comparison between groups. Proportion of SARS-nCoV-2 free patients during the first 28 days after enrollment [ Time Frame: 28 days ]Daily proportion of patients with a PaO2/FiO2 ratio > 300 for at least 24 hours within each group and comparison between groups. If a patient dies before day 28, the patient will be considered as ""never recovered"".
Survival at 28 days from enrollment [ Time Frame: 28 days ]Proportion of patients surviving at 28 days within each group and comparison between groups.
Survival at 90 days from enrollment [ Time Frame: 90 days ]Proportion of patients surviving at 90 days within each group and comparison between groups. Survival at 28 days from enrollment [ Time Frame: 28 days ]Proportion of patients surviving at 28 days within each group and comparison between groups.
Survival at 90 days from enrollment [ Time Frame: 90 days ]Proportion of patients surviving at 90 days within each group and comparison between groups. Survival at 90 days from enrollment [ Time Frame: 90 days ]Proportion of patients surviving at 90 days within each group and comparison between groups.",200
158,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04322773,Time to independence from supplementary oxygen therapy [ Time Frame: days from enrolment up 30 days ],"Number of deaths [ Time Frame: 30 days from enrolment ]
Days out of hospital and alive [ Time Frame: 30 days from enrolment ]
Ventilator free days alive and out of hospital [ Time Frame: 30 days from enrolment ]
C-reactive protein (CRP) level [ Time Frame: baseline ]
C-reactive protein (CRP) level [ Time Frame: peak during hospitalisation, up to 30 days ]
C-reactive protein (CRP) level [ Time Frame: 14 days ]
C-reactive protein (CRP) level [ Time Frame: 30 days ]
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) [ Time Frame: During treatment, up to 30 days ] Days out of hospital and alive [ Time Frame: 30 days from enrolment ]
Ventilator free days alive and out of hospital [ Time Frame: 30 days from enrolment ]
C-reactive protein (CRP) level [ Time Frame: baseline ]
C-reactive protein (CRP) level [ Time Frame: peak during hospitalisation, up to 30 days ]
C-reactive protein (CRP) level [ Time Frame: 14 days ]
C-reactive protein (CRP) level [ Time Frame: 30 days ]
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) [ Time Frame: During treatment, up to 30 days ] Ventilator free days alive and out of hospital [ Time Frame: 30 days from enrolment ]
C-reactive protein (CRP) level [ Time Frame: baseline ]
C-reactive protein (CRP) level [ Time Frame: peak during hospitalisation, up to 30 days ]
C-reactive protein (CRP) level [ Time Frame: 14 days ]
C-reactive protein (CRP) level [ Time Frame: 30 days ]
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) [ Time Frame: During treatment, up to 30 days ] C-reactive protein (CRP) level [ Time Frame: baseline ]
C-reactive protein (CRP) level [ Time Frame: peak during hospitalisation, up to 30 days ]
C-reactive protein (CRP) level [ Time Frame: 14 days ]
C-reactive protein (CRP) level [ Time Frame: 30 days ]
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) [ Time Frame: During treatment, up to 30 days ] C-reactive protein (CRP) level [ Time Frame: peak during hospitalisation, up to 30 days ]
C-reactive protein (CRP) level [ Time Frame: 14 days ]
C-reactive protein (CRP) level [ Time Frame: 30 days ]
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) [ Time Frame: During treatment, up to 30 days ] C-reactive protein (CRP) level [ Time Frame: 14 days ]
C-reactive protein (CRP) level [ Time Frame: 30 days ]
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) [ Time Frame: During treatment, up to 30 days ] C-reactive protein (CRP) level [ Time Frame: 30 days ]
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) [ Time Frame: During treatment, up to 30 days ] Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) [ Time Frame: During treatment, up to 30 days ]",200
159,Not yet recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04322123,"Evaluation of the clinical status [ Time Frame: 15 days after randomization ]Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points.

Alive at home
In the hospital without oxygen
In the hospital using oxygen
In the hospital using high-flow nasal catheter or non-invasive ventilation
In hospital, on mechanical ventilation
Dead Alive at home In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead","Alive at home In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead",630
160,Recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04264533,Ventilation-free days [ Time Frame: on the day 28 after enrollment ]days without ventilation support during 28 days after patients' enrollment,"28-days mortality [ Time Frame: on the day 28 after enrollment ]wether the patient survives
ICU length of stay [ Time Frame: on the day 28 after enrollment ]days of the patients staying in the ICU
Demand for first aid measuments [ Time Frame: on the day 28 after enrollment ]the rate of CPR
Vasopressor days [ Time Frame: on the day 28 after enrollment ]days of using vasopressors
Respiratory indexes [ Time Frame: on the day 10 and 28 after enrollment ]P O2/Fi O2 which reflects patients' respiratory function
Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]Ecmo or ventilator
APACHE II scores [ Time Frame: on the day 10 after enrollment ]Acute Physiology and Chronic Health Evaluation
SOFA scores [ Time Frame: on the day 10 after enrollment ]Sepsis-related Organ Failure Assessment ICU length of stay [ Time Frame: on the day 28 after enrollment ]days of the patients staying in the ICU
Demand for first aid measuments [ Time Frame: on the day 28 after enrollment ]the rate of CPR
Vasopressor days [ Time Frame: on the day 28 after enrollment ]days of using vasopressors
Respiratory indexes [ Time Frame: on the day 10 and 28 after enrollment ]P O2/Fi O2 which reflects patients' respiratory function
Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]Ecmo or ventilator
APACHE II scores [ Time Frame: on the day 10 after enrollment ]Acute Physiology and Chronic Health Evaluation
SOFA scores [ Time Frame: on the day 10 after enrollment ]Sepsis-related Organ Failure Assessment Demand for first aid measuments [ Time Frame: on the day 28 after enrollment ]the rate of CPR
Vasopressor days [ Time Frame: on the day 28 after enrollment ]days of using vasopressors
Respiratory indexes [ Time Frame: on the day 10 and 28 after enrollment ]P O2/Fi O2 which reflects patients' respiratory function
Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]Ecmo or ventilator
APACHE II scores [ Time Frame: on the day 10 after enrollment ]Acute Physiology and Chronic Health Evaluation
SOFA scores [ Time Frame: on the day 10 after enrollment ]Sepsis-related Organ Failure Assessment Vasopressor days [ Time Frame: on the day 28 after enrollment ]days of using vasopressors
Respiratory indexes [ Time Frame: on the day 10 and 28 after enrollment ]P O2/Fi O2 which reflects patients' respiratory function
Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]Ecmo or ventilator
APACHE II scores [ Time Frame: on the day 10 after enrollment ]Acute Physiology and Chronic Health Evaluation
SOFA scores [ Time Frame: on the day 10 after enrollment ]Sepsis-related Organ Failure Assessment Respiratory indexes [ Time Frame: on the day 10 and 28 after enrollment ]P O2/Fi O2 which reflects patients' respiratory function
Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]Ecmo or ventilator
APACHE II scores [ Time Frame: on the day 10 after enrollment ]Acute Physiology and Chronic Health Evaluation
SOFA scores [ Time Frame: on the day 10 after enrollment ]Sepsis-related Organ Failure Assessment Ventilator parameters [ Time Frame: on the day 10 and 28 after enrollment ]Ecmo or ventilator
APACHE II scores [ Time Frame: on the day 10 after enrollment ]Acute Physiology and Chronic Health Evaluation
SOFA scores [ Time Frame: on the day 10 after enrollment ]Sepsis-related Organ Failure Assessment APACHE II scores [ Time Frame: on the day 10 after enrollment ]Acute Physiology and Chronic Health Evaluation
SOFA scores [ Time Frame: on the day 10 after enrollment ]Sepsis-related Organ Failure Assessment SOFA scores [ Time Frame: on the day 10 after enrollment ]Sepsis-related Organ Failure Assessment",140
161,Not yet recruiting,Not Applicable,All,"18 Years to 70 Years   (Adult, Older Adult)",NCT04275388,"Clinical recovery time [ Time Frame: Up to Day 14 ]From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours","Complete fever time [ Time Frame: Up to Day 14 ]From the beginning of research drug use to body temperature <37.3 ℃ (underarm) or mouth temperature ≤37.5 ° C, or anal or ear temperature ≤37.8 ° C, and maintained for 24h or more
Cough relief time [ Time Frame: Up to Day 14 ]Cough score ""day + night"" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above
Virus negative time [ Time Frame: Up to Day 14 ]From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)
Incidence of severe or critical neocoronavirus pneumonia [ Time Frame: Up to Day 14 ]Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia Cough relief time [ Time Frame: Up to Day 14 ]Cough score ""day + night"" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above
Virus negative time [ Time Frame: Up to Day 14 ]From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)
Incidence of severe or critical neocoronavirus pneumonia [ Time Frame: Up to Day 14 ]Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia Virus negative time [ Time Frame: Up to Day 14 ]From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)
Incidence of severe or critical neocoronavirus pneumonia [ Time Frame: Up to Day 14 ]Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia Incidence of severe or critical neocoronavirus pneumonia [ Time Frame: Up to Day 14 ]Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia",348
162,Recruiting,Phase 2,All,"18 Years to 100 Years   (Adult, Older Adult)",NCT04323527,Absolute mortality at day 28 [ Time Frame: 28 days after drug first dose ]number of deaths at day 28 between groups compared,"Absolute mortality on days 7 and 14 [ Time Frame: 7 and 14 days after first dose ]number of deaths at days 7 and 14 between groups compared
Improvement in overall subject's clinical status assessed in standardized clinical questionnaires on days 14 and 28 [ Time Frame: 14 and 28 days after first dose ]clinical status
Improvement in daily clinical status assessed in standardized clinical questionnaires during hospitalization [ Time Frame: during and after intervention, up to 28 days ]clinical status
Duration of supplemental oxygen (if applicable) [ Time Frame: during and after intervention, up to 28 days ]supplemental oxygen
Duration of mechanical ventilation (if applicable) [ Time Frame: during and after intervention, up to 28 days ]mechanical ventilation
Absolute duration of hospital stay in days [ Time Frame: during and after intervention, up to 28 days ]hospitalization
Prevalence of grade 3 and 4 adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events grade 3 and 4
Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Improvement in overall subject's clinical status assessed in standardized clinical questionnaires on days 14 and 28 [ Time Frame: 14 and 28 days after first dose ]clinical status
Improvement in daily clinical status assessed in standardized clinical questionnaires during hospitalization [ Time Frame: during and after intervention, up to 28 days ]clinical status
Duration of supplemental oxygen (if applicable) [ Time Frame: during and after intervention, up to 28 days ]supplemental oxygen
Duration of mechanical ventilation (if applicable) [ Time Frame: during and after intervention, up to 28 days ]mechanical ventilation
Absolute duration of hospital stay in days [ Time Frame: during and after intervention, up to 28 days ]hospitalization
Prevalence of grade 3 and 4 adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events grade 3 and 4
Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Improvement in daily clinical status assessed in standardized clinical questionnaires during hospitalization [ Time Frame: during and after intervention, up to 28 days ]clinical status
Duration of supplemental oxygen (if applicable) [ Time Frame: during and after intervention, up to 28 days ]supplemental oxygen
Duration of mechanical ventilation (if applicable) [ Time Frame: during and after intervention, up to 28 days ]mechanical ventilation
Absolute duration of hospital stay in days [ Time Frame: during and after intervention, up to 28 days ]hospitalization
Prevalence of grade 3 and 4 adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events grade 3 and 4
Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Duration of supplemental oxygen (if applicable) [ Time Frame: during and after intervention, up to 28 days ]supplemental oxygen
Duration of mechanical ventilation (if applicable) [ Time Frame: during and after intervention, up to 28 days ]mechanical ventilation
Absolute duration of hospital stay in days [ Time Frame: during and after intervention, up to 28 days ]hospitalization
Prevalence of grade 3 and 4 adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events grade 3 and 4
Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Duration of mechanical ventilation (if applicable) [ Time Frame: during and after intervention, up to 28 days ]mechanical ventilation
Absolute duration of hospital stay in days [ Time Frame: during and after intervention, up to 28 days ]hospitalization
Prevalence of grade 3 and 4 adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events grade 3 and 4
Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Absolute duration of hospital stay in days [ Time Frame: during and after intervention, up to 28 days ]hospitalization
Prevalence of grade 3 and 4 adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events grade 3 and 4
Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Prevalence of grade 3 and 4 adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events grade 3 and 4
Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Prevalence of serious adverse events [ Time Frame: during and after intervention, up to 28 days ]adverse events
Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Change in serum creatinine level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum creatinine compared to baseline
Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Change in serum troponin I level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum troponin I compared to baseline
Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Change in serum aspartate aminotransferase level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Change in serum CK-MB level [ Time Frame: during and after intervention, up to 28 days ]increase or decrease in serum aspartate aminotransferase compared to baseline
Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Change in detectable viral load in respiratory tract swabs [ Time Frame: during and after intervention, up to 28 days ]virus clearance from respiratory tract secretion
Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Viral concentration in blood samples [ Time Frame: during and after intervention, up to 28 days ]viremia in blood detected through RT-PCR
Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death Absolute number of causes leading to participant death (if applicable) [ Time Frame: during and after intervention, up to 28 days ]death",440
163,Recruiting,,All,"1 Year to 90 Years   (Child, Adult, Older Adult)",NCT04245631,"Detection sensitivity is greater than 95% [ Time Frame: at baseline ]Detection sensitivity is greater than 95%
Detection specificity is greater than 95% [ Time Frame: at baseline ]Detection specificity is greater than 95% Detection specificity is greater than 95% [ Time Frame: at baseline ]Detection specificity is greater than 95%",Consistent with existing universal reagent detection rates greater than 95% [ Time Frame: at baseline ]Consistent with existing universal reagent detection rates greater than 95%,50
164,Recruiting,Phase 1,All,18 Years to 55 Years   (Adult),NCT04283461,"Frequency of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Frequency of any medically-attended adverse events (MAAEs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any new-onset chronic medical conditions (NOCMCs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any serious adverse events (SAEs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Frequency of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ] Frequency of any medically-attended adverse events (MAAEs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any new-onset chronic medical conditions (NOCMCs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any serious adverse events (SAEs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Frequency of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ] Frequency of any new-onset chronic medical conditions (NOCMCs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any serious adverse events (SAEs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Frequency of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ] Frequency of any serious adverse events (SAEs) [ Time Frame: Day 1 to Day 394 ]
Frequency of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Frequency of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ] Frequency of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Frequency of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ] Frequency of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ] Grade of any unsolicited adverse events (AEs) [ Time Frame: Through 28 days post-vaccination ]
Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ] Grade of solicited local reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]
Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ] Grade of solicited systemic reactogenicity adverse events (AEs) [ Time Frame: Through 7 days post-vaccination ]","Geometric mean fold rise (GMFR) in IgG titer from baseline [ Time Frame: Day 1 to Day 57 ]
Geometric mean titer (GMT) of antibody [ Time Frame: Day 57 ]
Percentage of subjects who seroconverted [ Time Frame: Day 1 to Day 57 ]Seroconversion is defined as a 4-fold change in antibody titer from baseline Geometric mean titer (GMT) of antibody [ Time Frame: Day 57 ]
Percentage of subjects who seroconverted [ Time Frame: Day 1 to Day 57 ]Seroconversion is defined as a 4-fold change in antibody titer from baseline Percentage of subjects who seroconverted [ Time Frame: Day 1 to Day 57 ]Seroconversion is defined as a 4-fold change in antibody titer from baseline",45
165,Not yet recruiting,,All,"Child, Adult, Older Adult",NCT04324736,Assess the prevalence of severe forms among hospitalized COVID-19 diabetics [ Time Frame: 1 month ]Prevalence of severe forms among all COVID-19 patients with diabetes,"describe the clinical characteristics of diabetic subjects treated in hospital for COVID-19 [ Time Frame: 1 month ]Use of general socio-demographic characteristics of patients, type of diabetes, history of hypoglycaemia, complications associated with diabetes
describe the biological characteristics of diabetic subjects treated in hospital for COVID-19 [ Time Frame: 1 month ]Use of glycated hemoglobin, glucose at admission, fasting glucose in the first 3 days of follow-up, creatinine, liver function markers, blood count, nutritional markers, inflammatory markers, hemostasis
describe the prognosis of diabetic subjects hospitalized for COVID-19 [ Time Frame: 1 month ]death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit
describe the management of diabetic patients hospitalized for COVID-19 [ Time Frame: 1 month ]care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7 describe the biological characteristics of diabetic subjects treated in hospital for COVID-19 [ Time Frame: 1 month ]Use of glycated hemoglobin, glucose at admission, fasting glucose in the first 3 days of follow-up, creatinine, liver function markers, blood count, nutritional markers, inflammatory markers, hemostasis
describe the prognosis of diabetic subjects hospitalized for COVID-19 [ Time Frame: 1 month ]death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit
describe the management of diabetic patients hospitalized for COVID-19 [ Time Frame: 1 month ]care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7 describe the prognosis of diabetic subjects hospitalized for COVID-19 [ Time Frame: 1 month ]death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit
describe the management of diabetic patients hospitalized for COVID-19 [ Time Frame: 1 month ]care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7 describe the management of diabetic patients hospitalized for COVID-19 [ Time Frame: 1 month ]care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7",300
166,Recruiting,Phase 3,All,"40 Years and older   (Adult, Older Adult)",NCT04322682,Number of participants who die or require hospitalization due to COVID-19 infection [ Time Frame: 30 days post randomization ]The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.,"Number of participants who die [ Time Frame: 30 days post randomization ]The secondary endpoint is the occurrence of death in the 30 days following randomization.
Number of participants requiring hospitalization due to COVID-19 infection [ Time Frame: 30 days post randomization ]The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.
Number of participants requiring mechanical ventilation [ Time Frame: 30 days post randomization ]The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization. Number of participants requiring hospitalization due to COVID-19 infection [ Time Frame: 30 days post randomization ]The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.
Number of participants requiring mechanical ventilation [ Time Frame: 30 days post randomization ]The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization. Number of participants requiring mechanical ventilation [ Time Frame: 30 days post randomization ]The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.",6000
167,Recruiting,,All,"Child, Adult, Older Adult",NCT04255940,Cardiovascular Death [ Time Frame: 3 months ],"Major Adverse Cardiovascular Events [ Time Frame: 3 months ]
Times From symptom onset to hospital arrival [ Time Frame: 3 months ]
Anxiety [ Time Frame: 3 months ] Times From symptom onset to hospital arrival [ Time Frame: 3 months ]
Anxiety [ Time Frame: 3 months ] Anxiety [ Time Frame: 3 months ]",12000
168,Recruiting,,All,"21 Years and older   (Adult, Older Adult)",NCT04305574,"Assessment of COVID-19 situation [ Time Frame: Single measurement (upon study enrolment) ]3 items on fear of the situation, confidence the government can manage the situation, and assessed chance of being infected (each rated using 4-point scales: min = 1, max = 4; higher scores indicate increased confidence / likelihood / fear)
Depression, Anxiety and Stress Scale [ Time Frame: Single measurement (upon study enrolment) ]21-item validated scale assessing symptoms of depression, anxiety, and stress (DASS-21): Min score = 0, Max score = 21; higher score indicates a worse outcome Depression, Anxiety and Stress Scale [ Time Frame: Single measurement (upon study enrolment) ]21-item validated scale assessing symptoms of depression, anxiety, and stress (DASS-21): Min score = 0, Max score = 21; higher score indicates a worse outcome","Familiarity and trust in COVID-related rumours [ Time Frame: Single measurement (upon study enrolment) ]Participants' self-report of their familiarity (yes/no) and belief of specific (yes/no), and whether they shared these on social media (yes/no)
Availability heuristic [ Time Frame: Single measurement (upon study enrolment) ]Participants' assessment of how many cases there have been in COVID-19 and SARS Availability heuristic [ Time Frame: Single measurement (upon study enrolment) ]Participants' assessment of how many cases there have been in COVID-19 and SARS",5000
169,Not yet recruiting,Phase 2,All,"18 Years to 90 Years   (Adult, Older Adult)",NCT04315480,"arrest in deterioration of pulmonary function [ Time Frame: 7days ]rate of patients with no need in increase of FiO2 to maintain stable SO2 and no need of intubation
improving in pulmonary function [ Time Frame: 7 days ]rate of patients with change of oxygen saturation >3 percentage points or >10% or decrease in FiO2 need or reduction in pulmonary consolidations >30% at HR CT-scan improving in pulmonary function [ Time Frame: 7 days ]rate of patients with change of oxygen saturation >3 percentage points or >10% or decrease in FiO2 need or reduction in pulmonary consolidations >30% at HR CT-scan","need of oro-tracheal intubation [ Time Frame: +7 days ]rate of patients needed of intubation
death [ Time Frame: 14days ]rate of patients dead death [ Time Frame: 14days ]rate of patients dead",30
170,Recruiting,,All,"14 Years to 75 Years   (Child, Adult, Older Adult)",NCT04322513,"Biomarkers expression [ Time Frame: up to 30 days ]Change in biomarkers (microRNAs, oxidative stress, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) in covid-19 positive patients vs covid-negative patients
Liver Biomarkers expression [ Time Frame: up to 30 days ]Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy Liver Biomarkers expression [ Time Frame: up to 30 days ]Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy","biomarkers expression (microRNAs, oxidative stress, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment [ Time Frame: 60 days ]Changes in biomarkers in covid-19 patients before and after standard treatment",110
171,Recruiting,,All,"Child, Adult, Older Adult",NCT04290780,"Other: nosocomial infection/hospital acquired infection
When there is suspicion of a community-acquired case (admission of an infected patient) or nosocomial case (infection of a patient already hospitalized), a case report form including demographic data, medical history, and clinical and biological data on the infectious episode will be completed for each case, either patient, caregivers or health care professionals, presenting clinical signs or symptoms compatible with SARS-CoV-2 infection. The suspected cases will undergo nasopharyngeal swab collection and detection of SARS-CoV-2 in nasopharyngeal swabs will be done by real-time RT-PCR assay.
Hygiene measures applied by the service will be collected using a questionnaire as well as recommendations of the learned societies within the country regarding the risk of infection by coronavirus. In addition, data characterizing the service and hospital will also be collected (specialty, number of beds, number of nurses, doctors, etc.).","nosocomial infection [ Time Frame: At inclusion ]The primary outcome criteria will be the proportion of patients, caregivers and health care professionals with confirmed or suspected SARS-CoV-2 nosocomial infection relative to all patients, caregivers and health care professionals with syndromes suggestive of SARS-CoV-2 infection during the study period. The infection control measures will be reported and describe according the nosocomial cases.",300
172,Not yet recruiting,Not Applicable,All,"Child, Adult, Older Adult",NCT04281693,Screening accuracy [ Time Frame: 1 month ]The screening accuracy of the two screening strategies were calculated and compared.,Cost-effectiveness analysis [ Time Frame: 1 month ]The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.,230
173,Recruiting,,All,"Child, Adult, Older Adult",NCT04259892,"Biological: 2019-nCoV PCR
Nasopharyngeal swabs",Number of Participants with presence of 2019-nCoV in at least one of nasopharyngeal swab [ Time Frame: 14 days ]PCR,300
174,Recruiting,Phase 3,All,"Child, Adult, Older Adult",NCT04252274,"The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]","The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after randomization ]
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [ Time Frame: 5 days after randomization ]
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 14 days after randomization ]
The critical illness rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.
The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ] The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [ Time Frame: 5 days after randomization ]
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 14 days after randomization ]
The critical illness rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.
The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ] Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 14 days after randomization ]
The critical illness rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.
The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ] The critical illness rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.
The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ] The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]",30
175,Completed,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04261517,"The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after randomization ]
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [ Time Frame: 5 days after randomization ]
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]
The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ] The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [ Time Frame: 5 days after randomization ]
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]
The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ] The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]
The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ] The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]","Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 14 days after randomization ]
The critical illness rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China. The critical illness rate of subjects at weeks 2 [ Time Frame: 14 days after randomization ]The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.",30
176,Completed,,All,"Child, Adult, Older Adult",NCT04321369,"Diagnostic Test: Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals
This is an operational project. Patients will collect a sample from the tongue, nasal cavity and MT and then clinicians will collect a NP sample from the nostril corresponding to each participant's dominant hand.","Accuracy of patient administered tests [ Time Frame: 2 weeks ]compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting",533
177,Recruiting,Not Applicable,All,"14 Years to 80 Years   (Child, Adult, Older Adult)",NCT04251871,Time to complete remission of 2019-nCoV infection-associated symptoms [ Time Frame: 28 days ]Symptoms associated with 2019-nCoV infection involve fever and cough.,"The incidence of dyspnea with low oxygen saturation level and high respiratory rate [ Time Frame: 28 days ]In eligible subjects, the oxygen saturation level is less than 94%, and the respiratory rate is more than 24 breaths per min.
Number of subjects who develop complications of 2019-nCoV infection [ Time Frame: 28 days ]Number of subjects who develop complications, including acute respiratory distress syndrome (ARDS), RNAaemia, acute cardiac injury, acute kidney injury (AKI), secondary infection and shock, will be described.
Time to virus shedding [ Time Frame: 28 days ]Virus shedding was detected twice at least a day apart.
Time to improvement of abnormalities in Chest radiology [ Time Frame: 28 days ]improvement of chest radiographic evidence indirectly reflects recovery in patients infected with 2019-nCoV.
The evaluation of Traditional Chinese Medicine (TCM) symptoms before and after treatment [ Time Frame: 28 days ]The changes of TCM symptoms before and after treatment reveal the effect of TCM treatment for 2019-nCoV infection. Number of subjects who develop complications of 2019-nCoV infection [ Time Frame: 28 days ]Number of subjects who develop complications, including acute respiratory distress syndrome (ARDS), RNAaemia, acute cardiac injury, acute kidney injury (AKI), secondary infection and shock, will be described.
Time to virus shedding [ Time Frame: 28 days ]Virus shedding was detected twice at least a day apart.
Time to improvement of abnormalities in Chest radiology [ Time Frame: 28 days ]improvement of chest radiographic evidence indirectly reflects recovery in patients infected with 2019-nCoV.
The evaluation of Traditional Chinese Medicine (TCM) symptoms before and after treatment [ Time Frame: 28 days ]The changes of TCM symptoms before and after treatment reveal the effect of TCM treatment for 2019-nCoV infection. Time to virus shedding [ Time Frame: 28 days ]Virus shedding was detected twice at least a day apart.
Time to improvement of abnormalities in Chest radiology [ Time Frame: 28 days ]improvement of chest radiographic evidence indirectly reflects recovery in patients infected with 2019-nCoV.
The evaluation of Traditional Chinese Medicine (TCM) symptoms before and after treatment [ Time Frame: 28 days ]The changes of TCM symptoms before and after treatment reveal the effect of TCM treatment for 2019-nCoV infection. Time to improvement of abnormalities in Chest radiology [ Time Frame: 28 days ]improvement of chest radiographic evidence indirectly reflects recovery in patients infected with 2019-nCoV.
The evaluation of Traditional Chinese Medicine (TCM) symptoms before and after treatment [ Time Frame: 28 days ]The changes of TCM symptoms before and after treatment reveal the effect of TCM treatment for 2019-nCoV infection. The evaluation of Traditional Chinese Medicine (TCM) symptoms before and after treatment [ Time Frame: 28 days ]The changes of TCM symptoms before and after treatment reveal the effect of TCM treatment for 2019-nCoV infection.",150
178,Recruiting,,All,"Child, Adult, Older Adult",NCT04260308,Voluntary residents Can use mobile phone or computer,Voluntary residents Can use mobile phone or computer,30000
179,Recruiting,"Phase 1
Phase 2",All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04275245,"2019 nCoV nucleic acid detection [ Time Frame: 14 days ]Virological clearance rate using Real-Time PCR in upper and/or lower respiratory tract samples at day 3, day 7 and day 14 respectively.","Recovery of body temperature [ Time Frame: 14 days ]Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)
Recovery of resting respiratory rate [ Time Frame: 14 days ]Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)
Recovery of SPO2 [ Time Frame: 14 days ]Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)
Chest CT / chest film changes [ Time Frame: 28 days ]Rate of lung imaging recovery
PaO2 / FiO2 [ Time Frame: 14 days ]Rate of PaO2 / FiO2 recovery
Time to reach the isolation release standard [ Time Frame: 28 days ]Days to reach the isolation release standard
Changes of inflammatory immune status [ Time Frame: 14 days ]Rate of CRP, D-Dimer test recovery Recovery of resting respiratory rate [ Time Frame: 14 days ]Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)
Recovery of SPO2 [ Time Frame: 14 days ]Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)
Chest CT / chest film changes [ Time Frame: 28 days ]Rate of lung imaging recovery
PaO2 / FiO2 [ Time Frame: 14 days ]Rate of PaO2 / FiO2 recovery
Time to reach the isolation release standard [ Time Frame: 28 days ]Days to reach the isolation release standard
Changes of inflammatory immune status [ Time Frame: 14 days ]Rate of CRP, D-Dimer test recovery Recovery of SPO2 [ Time Frame: 14 days ]Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)
Chest CT / chest film changes [ Time Frame: 28 days ]Rate of lung imaging recovery
PaO2 / FiO2 [ Time Frame: 14 days ]Rate of PaO2 / FiO2 recovery
Time to reach the isolation release standard [ Time Frame: 28 days ]Days to reach the isolation release standard
Changes of inflammatory immune status [ Time Frame: 14 days ]Rate of CRP, D-Dimer test recovery Chest CT / chest film changes [ Time Frame: 28 days ]Rate of lung imaging recovery
PaO2 / FiO2 [ Time Frame: 14 days ]Rate of PaO2 / FiO2 recovery
Time to reach the isolation release standard [ Time Frame: 28 days ]Days to reach the isolation release standard
Changes of inflammatory immune status [ Time Frame: 14 days ]Rate of CRP, D-Dimer test recovery PaO2 / FiO2 [ Time Frame: 14 days ]Rate of PaO2 / FiO2 recovery
Time to reach the isolation release standard [ Time Frame: 28 days ]Days to reach the isolation release standard
Changes of inflammatory immune status [ Time Frame: 14 days ]Rate of CRP, D-Dimer test recovery Time to reach the isolation release standard [ Time Frame: 28 days ]Days to reach the isolation release standard
Changes of inflammatory immune status [ Time Frame: 14 days ]Rate of CRP, D-Dimer test recovery Changes of inflammatory immune status [ Time Frame: 14 days ]Rate of CRP, D-Dimer test recovery",20
180,Not yet recruiting,,All,"18 Years and older   (Adult, Older Adult)",NCT04307459,Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection [ Time Frame: 1-6 months ]Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome,"in-hospital mortality [ Time Frame: 1 month ]How many patients died during the hospitalization
30 days mortality [ Time Frame: 1 month ]How many patients died 30 days after the discharge
6 months mortality [ Time Frame: 6 months ]How many patients died 6 months after the discharge
Intubation rate [ Time Frame: 7 days ]How many patients were intubated during the hospitalization
Time to Intubation [ Time Frame: 7 days ]How many days/hours from admittance to intubation
Time to ventilation [ Time Frame: 7 days ]How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Non invasive to Invasive time [ Time Frame: 7 days ]How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. 30 days mortality [ Time Frame: 1 month ]How many patients died 30 days after the discharge
6 months mortality [ Time Frame: 6 months ]How many patients died 6 months after the discharge
Intubation rate [ Time Frame: 7 days ]How many patients were intubated during the hospitalization
Time to Intubation [ Time Frame: 7 days ]How many days/hours from admittance to intubation
Time to ventilation [ Time Frame: 7 days ]How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Non invasive to Invasive time [ Time Frame: 7 days ]How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. 6 months mortality [ Time Frame: 6 months ]How many patients died 6 months after the discharge
Intubation rate [ Time Frame: 7 days ]How many patients were intubated during the hospitalization
Time to Intubation [ Time Frame: 7 days ]How many days/hours from admittance to intubation
Time to ventilation [ Time Frame: 7 days ]How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Non invasive to Invasive time [ Time Frame: 7 days ]How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Intubation rate [ Time Frame: 7 days ]How many patients were intubated during the hospitalization
Time to Intubation [ Time Frame: 7 days ]How many days/hours from admittance to intubation
Time to ventilation [ Time Frame: 7 days ]How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Non invasive to Invasive time [ Time Frame: 7 days ]How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Time to Intubation [ Time Frame: 7 days ]How many days/hours from admittance to intubation
Time to ventilation [ Time Frame: 7 days ]How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Non invasive to Invasive time [ Time Frame: 7 days ]How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Time to ventilation [ Time Frame: 7 days ]How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Non invasive to Invasive time [ Time Frame: 7 days ]How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Non invasive to Invasive time [ Time Frame: 7 days ]How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.",50
181,Not yet recruiting,Phase 2,All,18 Years to 60 Years   (Adult),NCT04299152,Determine the number of Covid-19 patients who were unable to complete SCE Therapy [ Time Frame: 4 weeks ]The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.,"Examine the percentage of activated T cells after SCE therapy by flow cytometry [ Time Frame: 4 weeks ]Measurements of immune markers' changes will be preformed by flow cytometry such as activated T cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Assess the percentage of Th17 cells after SCE therapy by flow cytometry [ Time Frame: 4 weeks ]Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Chest imaging changes by computed tomography (CT) scan of the chest [ Time Frame: 4 weeks ]Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.
Quantification of the SARS-CoV-2 viral load by real time RT-PCR [ Time Frame: 4 weeks ]To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy. Assess the percentage of Th17 cells after SCE therapy by flow cytometry [ Time Frame: 4 weeks ]Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Chest imaging changes by computed tomography (CT) scan of the chest [ Time Frame: 4 weeks ]Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.
Quantification of the SARS-CoV-2 viral load by real time RT-PCR [ Time Frame: 4 weeks ]To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy. Chest imaging changes by computed tomography (CT) scan of the chest [ Time Frame: 4 weeks ]Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.
Quantification of the SARS-CoV-2 viral load by real time RT-PCR [ Time Frame: 4 weeks ]To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy. Quantification of the SARS-CoV-2 viral load by real time RT-PCR [ Time Frame: 4 weeks ]To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy.",20
182,Recruiting,,All,"Child, Adult, Older Adult",NCT04322279,"Diagnostic Test: Serology
SARS-CoV-2 serology Genetic: Sequencing
Whole exome sequencing",Number of Participants with positive serology in the 90 days following last contact [ Time Frame: 90 days ]microneutralisation assay,300
183,Not yet recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04325672,"RNA in SARS-CoV-2 [ Time Frame: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion ]Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
ICU Admissions [ Time Frame: 90 days after transfusion ]Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
Hospital Mortality [ Time Frame: 90 days after transfusion ]Total number of subject deaths.
Hospital Length of Stay (LOS) [ Time Frame: 90 days after transfusion ]The total number of days subjects were admitted to the hospital. ICU Admissions [ Time Frame: 90 days after transfusion ]Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
Hospital Mortality [ Time Frame: 90 days after transfusion ]Total number of subject deaths.
Hospital Length of Stay (LOS) [ Time Frame: 90 days after transfusion ]The total number of days subjects were admitted to the hospital. Hospital Mortality [ Time Frame: 90 days after transfusion ]Total number of subject deaths.
Hospital Length of Stay (LOS) [ Time Frame: 90 days after transfusion ]The total number of days subjects were admitted to the hospital. Hospital Length of Stay (LOS) [ Time Frame: 90 days after transfusion ]The total number of days subjects were admitted to the hospital.","Type of respiratory support [ Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first) ]The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
Duration of respiratory support [ Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first) ]The total number of days subjects required respiratory support. Duration of respiratory support [ Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first) ]The total number of days subjects required respiratory support.",20
184,Available,,All,"Child, Adult, Older Adult",NCT04302766,"Drug: Remdesivir
Remdesivir (RDV,GS-5734) is a monophosphoramidate prodrug of an adenosine analog with potent activity against an array of RNA virus families including Filoviridae, Paramyxoviridae, Pneumoviridae, and Orthocoronavirinae, through the targeting of the viral RNA dependent RNA polymerase (RdRp).
Other Name: GS-5734","DoD-affiliated personnel as defined in DoDI 6200.02, which includes emergency-essential civilian employees and/or contractor personnel accompanying the Armed Forces who are subject to the same health risk as military personnel Have a laboratory-confirmed COVID-19 diagnosis with moderate to severe disease presentation as determined by the principal investigator Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23 Understands and agrees to comply with planned study procedures Available for clinical follow-up for duration of the treatment and follow-up period Woman of childbearing potential must

Have a negative pregnancy test within 24 hours before starting treatment
Agree not to become pregnant during treatment and for 1 months after receiving remdesivir (Treatment will be a maximum of 10 doses given over a 10-day interval)
Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period Have a negative pregnancy test within 24 hours before starting treatment Agree not to become pregnant during treatment and for 1 months after receiving remdesivir (Treatment will be a maximum of 10 doses given over a 10-day interval) Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period",
185,Recruiting,,Female,"18 Years and older   (Adult, Older Adult)",NCT04323839,"Clinical presentation [ Time Frame: Baseline to 12 months ]presenting symptoms and testing
Disease prognosis outcomes [ Time Frame: Baseline to 12 months ]Clinical outcomes with resolution of illness
Pregnancy outcomes [ Time Frame: Baseline to 12 months ]Pregnancy outcomes among women infected with COVID-19
Obstetric outcomes [ Time Frame: Baseline to 12 months ]Obstetric outcomes among women infected with COVID-19
Neonatal outcomes [ Time Frame: Baseline to 12 months ]Neonatal outcomes among infants born to women with COVID-19
Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]Transmission of COVID-19 from mother to infant Disease prognosis outcomes [ Time Frame: Baseline to 12 months ]Clinical outcomes with resolution of illness
Pregnancy outcomes [ Time Frame: Baseline to 12 months ]Pregnancy outcomes among women infected with COVID-19
Obstetric outcomes [ Time Frame: Baseline to 12 months ]Obstetric outcomes among women infected with COVID-19
Neonatal outcomes [ Time Frame: Baseline to 12 months ]Neonatal outcomes among infants born to women with COVID-19
Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]Transmission of COVID-19 from mother to infant Pregnancy outcomes [ Time Frame: Baseline to 12 months ]Pregnancy outcomes among women infected with COVID-19
Obstetric outcomes [ Time Frame: Baseline to 12 months ]Obstetric outcomes among women infected with COVID-19
Neonatal outcomes [ Time Frame: Baseline to 12 months ]Neonatal outcomes among infants born to women with COVID-19
Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]Transmission of COVID-19 from mother to infant Obstetric outcomes [ Time Frame: Baseline to 12 months ]Obstetric outcomes among women infected with COVID-19
Neonatal outcomes [ Time Frame: Baseline to 12 months ]Neonatal outcomes among infants born to women with COVID-19
Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]Transmission of COVID-19 from mother to infant Neonatal outcomes [ Time Frame: Baseline to 12 months ]Neonatal outcomes among infants born to women with COVID-19
Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]Transmission of COVID-19 from mother to infant Modes of transmission of COVID-19 [ Time Frame: Baseline to 12 months ]Transmission of COVID-19 from mother to infant","Pregnant women or women who have been pregnant within the last 6 weeks Able to give informed consent Diagnosed with COVID-19; or being evaluated for COVID-19 (""patient under investigation"") since January 1, 2020",1000
186,Recruiting,,All,"up to 24 Years   (Child, Adult)",NCT04061382,"Feasibility of developing a UK based sero-epidemiological programme in 0-24 year olds [ Time Frame: 11months ]Measure the representativeness of participants as compared to the census data for the study region.
Feasibility of developing a UK based sero epidemiological survey in 0-24 year olds [ Time Frame: 11 months ]Test serological markers of immunity for vaccine preventable diseases starting with Diphtheria.
Feasibility of developing a UK based sero epidemiological survey in 0-24 year olds [ Time Frame: 11 months ]Test serological markers of immunity for vaccine preventable diseases including Invasive Meningococcal type C. Feasibility of developing a UK based sero epidemiological survey in 0-24 year olds [ Time Frame: 11 months ]Test serological markers of immunity for vaccine preventable diseases starting with Diphtheria.
Feasibility of developing a UK based sero epidemiological survey in 0-24 year olds [ Time Frame: 11 months ]Test serological markers of immunity for vaccine preventable diseases including Invasive Meningococcal type C. Feasibility of developing a UK based sero epidemiological survey in 0-24 year olds [ Time Frame: 11 months ]Test serological markers of immunity for vaccine preventable diseases including Invasive Meningococcal type C.","Recruitment rate [ Time Frame: 11 Months ]Recruitment rate per month, recruitment rates as percentage of potential participants contacted
Cost [ Time Frame: 11 months ]Cost per sample obtained of 'disease specific correlates of protection/markers of immunity, e.g. Anti-Diphtheria Toxoid IgG concentrations and capsular Group C meningococcal Serum bactericidal activity (SBA) titres
To assess, in relevant age groups, immunity against infections and vaccine preventable diseases [ Time Frame: 11 months ]IgG to COVID-19 spike protein
Sera collection [ Time Frame: 11 months ]A collection of anonymised sera from participants with appropriate consent and known demographic details and immunisation history Cost [ Time Frame: 11 months ]Cost per sample obtained of 'disease specific correlates of protection/markers of immunity, e.g. Anti-Diphtheria Toxoid IgG concentrations and capsular Group C meningococcal Serum bactericidal activity (SBA) titres
To assess, in relevant age groups, immunity against infections and vaccine preventable diseases [ Time Frame: 11 months ]IgG to COVID-19 spike protein
Sera collection [ Time Frame: 11 months ]A collection of anonymised sera from participants with appropriate consent and known demographic details and immunisation history To assess, in relevant age groups, immunity against infections and vaccine preventable diseases [ Time Frame: 11 months ]IgG to COVID-19 spike protein
Sera collection [ Time Frame: 11 months ]A collection of anonymised sera from participants with appropriate consent and known demographic details and immunisation history Sera collection [ Time Frame: 11 months ]A collection of anonymised sera from participants with appropriate consent and known demographic details and immunisation history",2300
187,"Active, not recruiting",Phase 2,All,"14 Years and older   (Child, Adult, Older Adult)",NCT03331445,as confirmed by no unanticipated adverse events Absence of a deleterious mean change in FEV1% predicted (absolute) from baseline,"as assessed by an improvement in CRISS Score on Day 5, 19 and 26 as compared to baseline measurement; as determined by improvement in six-minute walk test with one minute recovery as compared to baseline measurement.",20
188,Withdrawn,,All,"Child, Adult, Older Adult",NCT04280913,Time to negative conversion of severe acute respiratory syndrome coronavirus 2 [ Time Frame: 1 month ]The primary outcome is the time to negative conversion of coronavirus,"Length of stay in hospital [ Time Frame: 1 month ]The time of hospitalization.
Survival [ Time Frame: 1 month ]The rate of survival within hospitalization of these patients will be tracked.
Intubation [ Time Frame: 1 month ]The rate of intubation within hospitalization of these patients will be tracked. Survival [ Time Frame: 1 month ]The rate of survival within hospitalization of these patients will be tracked.
Intubation [ Time Frame: 1 month ]The rate of intubation within hospitalization of these patients will be tracked. Intubation [ Time Frame: 1 month ]The rate of intubation within hospitalization of these patients will be tracked.",0
189,Recruiting,Not Applicable,All,"18 Years and older   (Adult, Older Adult)",NCT04226157,Feasibility of blood pressure self management in stroke survivors [ Time Frame: Three Months ]At least 75 percent of HBPS participants will successfully complete the monitoring and self-titration intervention.,Systolic Blood Pressure Difference [ Time Frame: three months ]Difference in systolic blood pressure from baseline to three months between HBPS and Usual Care arms.,32
190,Not yet recruiting,,All,18 Years to 55 Years   (Adult),NCT04319211,"International Physical Activity Questionnaire (IPAQ) [ Time Frame: 4 weeks ]The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey validity and reliability studies have been conducted in Turkey by Ozturk. The survey consists of 27 questions and 5 parts.
Health-Related Quality of Life SF-12 Scale [ Time Frame: 4 weeks ]Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. SF-12 is an easy-to-apply 12-question scale that has been validated and reliable and obtained by shortening and simplifying SF-36, which evaluates the last 4 weeks.
Beck Depression Scale [ Time Frame: 4 weeks ]The individuals participating in our study will be evaluated with the Beck Depression Scale developed in 1961 by Beck et al. The scale validity and reliability studies have been conducted in Turkey by Hisli. The scale is a likert-type scale consisting of 21 items, each scored between 0-3. Health-Related Quality of Life SF-12 Scale [ Time Frame: 4 weeks ]Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. SF-12 is an easy-to-apply 12-question scale that has been validated and reliable and obtained by shortening and simplifying SF-36, which evaluates the last 4 weeks.
Beck Depression Scale [ Time Frame: 4 weeks ]The individuals participating in our study will be evaluated with the Beck Depression Scale developed in 1961 by Beck et al. The scale validity and reliability studies have been conducted in Turkey by Hisli. The scale is a likert-type scale consisting of 21 items, each scored between 0-3. Beck Depression Scale [ Time Frame: 4 weeks ]The individuals participating in our study will be evaluated with the Beck Depression Scale developed in 1961 by Beck et al. The scale validity and reliability studies have been conducted in Turkey by Hisli. The scale is a likert-type scale consisting of 21 items, each scored between 0-3.",Being between the ages of 18-55 To continue their active education or business life before the social isolation period. Spending time at home differently from routine life recently Having a smart phone Not having visual impairment Being literate in Turkish,200
191,Not yet recruiting,Not Applicable,All,"18 Years and older   (Adult, Older Adult)",NCT04320056,"The number of interventions [ Time Frame: Hour0 to Hour4 ]The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Duration of interventions [ Time Frame: Hour0 to Hour24 ]The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours Duration of interventions [ Time Frame: Hour0 to Hour24 ]The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours","Mean oxygen flow [ Time Frame: Hour0 to Hour24 (1 day) ]The Mean oxygen flow during study duration to evaluate oxygen consumption
Time within theSpO2 target [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 between 90 and 94%
Time with hypoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 < 88%
Time with hyperoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 > 96%
Rate of ICU admission [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of ICU admission
Rate of needed non invasive respiratory support [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of intubation
NEWS 2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay Time within theSpO2 target [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 between 90 and 94%
Time with hypoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 < 88%
Time with hyperoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 > 96%
Rate of ICU admission [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of ICU admission
Rate of needed non invasive respiratory support [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of intubation
NEWS 2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay Time with hypoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 < 88%
Time with hyperoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 > 96%
Rate of ICU admission [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of ICU admission
Rate of needed non invasive respiratory support [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of intubation
NEWS 2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay Time with hyperoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 > 96%
Rate of ICU admission [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of ICU admission
Rate of needed non invasive respiratory support [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of intubation
NEWS 2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay Rate of ICU admission [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of ICU admission
Rate of needed non invasive respiratory support [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of intubation
NEWS 2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay Rate of needed non invasive respiratory support [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of intubation
NEWS 2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of intubation
NEWS 2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay NEWS 2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.
The NEWS2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at NEWS 2 interpretation.
Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.
A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).
A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay EWSO2 score evolution [ Time Frame: Hour0 to Hour24 (1 day) ]Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution
The EWSO2 score will be calculate but no intervention will be made based on this score.
Patient evolution will be compare at EWSO2 interpretation.
Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay",216
192,Recruiting,Phase 1,All,"18 Years to 65 Years   (Adult, Older Adult)",NCT04280224,"Improvement of clinical symptoms including duration of fever [ Time Frame: Measured from day 0 through day 28 ]Evaluation of pneumonia improvement
Improvement of clinical symptoms including respiratory frequency [ Time Frame: Measured from day 0 through day 28 ]Evaluation of pneumonia improvement
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0 [ Time Frame: Measured from day 0 through day 28 ]Safety evaluation Improvement of clinical symptoms including respiratory frequency [ Time Frame: Measured from day 0 through day 28 ]Evaluation of pneumonia improvement
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0 [ Time Frame: Measured from day 0 through day 28 ]Safety evaluation Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0 [ Time Frame: Measured from day 0 through day 28 ]Safety evaluation","Time of virus nucleic acid test negative [ Time Frame: Measured from day 0 through day 28 ]Marker for 2019-nCoV
CD4+ and CD8+ T cell count [ Time Frame: Measured from day 0 through day 28 ]Marker of immunological function
Rate of mortality within 28-days [ Time Frame: Day 28 ]Marker for efficacy of treatment
Size of lesion area by thoracic imaging [ Time Frame: Measured from day 0 through day 28 ]Recovery of lung injury CD4+ and CD8+ T cell count [ Time Frame: Measured from day 0 through day 28 ]Marker of immunological function
Rate of mortality within 28-days [ Time Frame: Day 28 ]Marker for efficacy of treatment
Size of lesion area by thoracic imaging [ Time Frame: Measured from day 0 through day 28 ]Recovery of lung injury Rate of mortality within 28-days [ Time Frame: Day 28 ]Marker for efficacy of treatment
Size of lesion area by thoracic imaging [ Time Frame: Measured from day 0 through day 28 ]Recovery of lung injury Size of lesion area by thoracic imaging [ Time Frame: Measured from day 0 through day 28 ]Recovery of lung injury",30
193,Recruiting,"Phase 2
Phase 3",All,"18 Years and older   (Adult, Older Adult)",NCT04244591,"Lower Murray lung injury score [ Time Frame: 7 days after randomization ]Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 16 according to the severity of the condition.
Lower Murray lung injury score [ Time Frame: 14 days after randomization ]Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 16 according to the severity of the condition. Lower Murray lung injury score [ Time Frame: 14 days after randomization ]Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 16 according to the severity of the condition.","The difference of PaO2/FiO2 between two groups [ Time Frame: 7 days after randomization ]PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 7 days after randomization ]Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Mechanical ventilation support [ Time Frame: 7 days after randomization ]Percentage of patients requiring Mechanical ventilation support
The difference of PaO2/FiO2 between two groups [ Time Frame: 14 days after randomization ]PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 14 days after randomization ]Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Mechanical ventilation support [ Time Frame: 14 days after randomization ]Percentage of patients requiring Mechanical ventilation support
Clearance of noval coronavirus [ Time Frame: 14 days after randomization ]Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality [ Time Frame: 30 days after randomization ]All-cause mortality Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 7 days after randomization ]Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Mechanical ventilation support [ Time Frame: 7 days after randomization ]Percentage of patients requiring Mechanical ventilation support
The difference of PaO2/FiO2 between two groups [ Time Frame: 14 days after randomization ]PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 14 days after randomization ]Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Mechanical ventilation support [ Time Frame: 14 days after randomization ]Percentage of patients requiring Mechanical ventilation support
Clearance of noval coronavirus [ Time Frame: 14 days after randomization ]Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality [ Time Frame: 30 days after randomization ]All-cause mortality Mechanical ventilation support [ Time Frame: 7 days after randomization ]Percentage of patients requiring Mechanical ventilation support
The difference of PaO2/FiO2 between two groups [ Time Frame: 14 days after randomization ]PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 14 days after randomization ]Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Mechanical ventilation support [ Time Frame: 14 days after randomization ]Percentage of patients requiring Mechanical ventilation support
Clearance of noval coronavirus [ Time Frame: 14 days after randomization ]Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality [ Time Frame: 30 days after randomization ]All-cause mortality The difference of PaO2/FiO2 between two groups [ Time Frame: 14 days after randomization ]PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 14 days after randomization ]Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Mechanical ventilation support [ Time Frame: 14 days after randomization ]Percentage of patients requiring Mechanical ventilation support
Clearance of noval coronavirus [ Time Frame: 14 days after randomization ]Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality [ Time Frame: 30 days after randomization ]All-cause mortality Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 14 days after randomization ]Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Mechanical ventilation support [ Time Frame: 14 days after randomization ]Percentage of patients requiring Mechanical ventilation support
Clearance of noval coronavirus [ Time Frame: 14 days after randomization ]Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality [ Time Frame: 30 days after randomization ]All-cause mortality Mechanical ventilation support [ Time Frame: 14 days after randomization ]Percentage of patients requiring Mechanical ventilation support
Clearance of noval coronavirus [ Time Frame: 14 days after randomization ]Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality [ Time Frame: 30 days after randomization ]All-cause mortality Clearance of noval coronavirus [ Time Frame: 14 days after randomization ]Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality [ Time Frame: 30 days after randomization ]All-cause mortality All-cause mortality [ Time Frame: 30 days after randomization ]All-cause mortality",80
194,Not yet recruiting,Phase 4,All,"18 Years and older   (Adult, Older Adult)",NCT04316377,Rate of decline in SARS-CoV-2 viral load [ Time Frame: Baseline (at randomization) and at 96 hours ]Viral load assessed by real time polymerase chain reaction in nasopharyngeal samples,"Change in National Early Warning Score score [ Time Frame: Baseline (at randomization) and at 96 hours ]National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.
Admission to intensive care unit [ Time Frame: At all times after randomization during index admission (between admission and discharge, approximately 21 days) ]Transfer from regular ward to intensive care unit during index admission
In-hospital mortality [ Time Frame: At all times after randomization during index admission (between admission and discharge, approximately 21 days) ]All-cause mortality during index admission
Duration of hospital admission [ Time Frame: During index admission (between admission and discharge, approximately 21 days) ]Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Mortality at 30 and 90 days [ Time Frame: At follow-up 30 and 90 days ]All-cause mortality assessed at 30 and 90 days
Clinical status [ Time Frame: 14 days after randomization ]Percentage of subjects reporting each severity rating on a 6-point ordinal scale:

Death
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, requiring supplemental oxygen
Hospitalized, not requiring supplemental oxygen
Not hospitalized Admission to intensive care unit [ Time Frame: At all times after randomization during index admission (between admission and discharge, approximately 21 days) ]Transfer from regular ward to intensive care unit during index admission
In-hospital mortality [ Time Frame: At all times after randomization during index admission (between admission and discharge, approximately 21 days) ]All-cause mortality during index admission
Duration of hospital admission [ Time Frame: During index admission (between admission and discharge, approximately 21 days) ]Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Mortality at 30 and 90 days [ Time Frame: At follow-up 30 and 90 days ]All-cause mortality assessed at 30 and 90 days
Clinical status [ Time Frame: 14 days after randomization ]Percentage of subjects reporting each severity rating on a 6-point ordinal scale:

Death
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, requiring supplemental oxygen
Hospitalized, not requiring supplemental oxygen
Not hospitalized In-hospital mortality [ Time Frame: At all times after randomization during index admission (between admission and discharge, approximately 21 days) ]All-cause mortality during index admission
Duration of hospital admission [ Time Frame: During index admission (between admission and discharge, approximately 21 days) ]Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Mortality at 30 and 90 days [ Time Frame: At follow-up 30 and 90 days ]All-cause mortality assessed at 30 and 90 days
Clinical status [ Time Frame: 14 days after randomization ]Percentage of subjects reporting each severity rating on a 6-point ordinal scale:

Death
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, requiring supplemental oxygen
Hospitalized, not requiring supplemental oxygen
Not hospitalized Duration of hospital admission [ Time Frame: During index admission (between admission and discharge, approximately 21 days) ]Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Mortality at 30 and 90 days [ Time Frame: At follow-up 30 and 90 days ]All-cause mortality assessed at 30 and 90 days
Clinical status [ Time Frame: 14 days after randomization ]Percentage of subjects reporting each severity rating on a 6-point ordinal scale:

Death
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, requiring supplemental oxygen
Hospitalized, not requiring supplemental oxygen
Not hospitalized Mortality at 30 and 90 days [ Time Frame: At follow-up 30 and 90 days ]All-cause mortality assessed at 30 and 90 days
Clinical status [ Time Frame: 14 days after randomization ]Percentage of subjects reporting each severity rating on a 6-point ordinal scale:

Death
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, requiring supplemental oxygen
Hospitalized, not requiring supplemental oxygen
Not hospitalized Clinical status [ Time Frame: 14 days after randomization ]Percentage of subjects reporting each severity rating on a 6-point ordinal scale:

Death
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
Hospitalized, on non-invasive ventilation or high flow oxygen devices
Hospitalized, requiring supplemental oxygen
Hospitalized, not requiring supplemental oxygen
Not hospitalized Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized",202
195,Recruiting,Phase 2,All,"18 Years and older   (Adult, Older Adult)",NCT04276688,Time to negative saliva 2019-n-CoV coronavirus viral RT-PCR Time to clinical improvement of NEWS2 (National Early Warning Score 2) of 0 maintained for 24 hours Length of hospitalisation Adverse events during treatment 30-day mortality Cytokine/ chemokine changes,Time to negative NPS [ Time Frame: Up to 1 month ]Time to negative NPS 2019-n-CoV RT-PCR,70
196,Not yet recruiting,,All,"Child, Adult, Older Adult",NCT04320862,"First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll. Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation. Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population.",Number of participants who experience inpatient admission [ Time Frame: 2 months ],20000
197,Not yet recruiting,,All,"16 Years and older   (Child, Adult, Older Adult)",NCT04319172,"Incidence of coronavirus infection in Solid Organ Transplant Recipients [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Number of Solid Organ Transplant Recipients positive to coronavirus
Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Number of participants who present clinical symptoms possibly related to coronavirus infection in Solid Organ Transplant Recipients
Presence of other risk factors [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Gathering possible risk factors in coronavirus infection in Solid Organ Transplant
Establish the frequency and type of complications related to the net state of the patient immunosuppression [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Establish the frequency and type of complications related to the net state of the patient immunosuppression Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Number of participants who present clinical symptoms possibly related to coronavirus infection in Solid Organ Transplant Recipients
Presence of other risk factors [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Gathering possible risk factors in coronavirus infection in Solid Organ Transplant
Establish the frequency and type of complications related to the net state of the patient immunosuppression [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Establish the frequency and type of complications related to the net state of the patient immunosuppression Presence of other risk factors [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Gathering possible risk factors in coronavirus infection in Solid Organ Transplant
Establish the frequency and type of complications related to the net state of the patient immunosuppression [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Establish the frequency and type of complications related to the net state of the patient immunosuppression Establish the frequency and type of complications related to the net state of the patient immunosuppression [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Establish the frequency and type of complications related to the net state of the patient immunosuppression","Frequency of co-infections [ Time Frame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus ]Another infections at the time of coronavirus positive infection will be gathered
Mortality [ Time Frame: From baseline at the time of signature of informed consent form to study completion ]Number of deaths in coronavirus infection in Solid Organ Transplant
Laboratory characteristics [ Time Frame: At inclusion and at 28 days of follow up ]Biochemical analysis, hemogram,
Determination of coronavirus viral load [ Time Frame: At inclusion at 14 days and at 28 days ]Nasopharyngeal swabs
Microbiological testing [ Time Frame: At inclusion at 14 days and at 28 days ]According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia Mortality [ Time Frame: From baseline at the time of signature of informed consent form to study completion ]Number of deaths in coronavirus infection in Solid Organ Transplant
Laboratory characteristics [ Time Frame: At inclusion and at 28 days of follow up ]Biochemical analysis, hemogram,
Determination of coronavirus viral load [ Time Frame: At inclusion at 14 days and at 28 days ]Nasopharyngeal swabs
Microbiological testing [ Time Frame: At inclusion at 14 days and at 28 days ]According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia Laboratory characteristics [ Time Frame: At inclusion and at 28 days of follow up ]Biochemical analysis, hemogram,
Determination of coronavirus viral load [ Time Frame: At inclusion at 14 days and at 28 days ]Nasopharyngeal swabs
Microbiological testing [ Time Frame: At inclusion at 14 days and at 28 days ]According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia Determination of coronavirus viral load [ Time Frame: At inclusion at 14 days and at 28 days ]Nasopharyngeal swabs
Microbiological testing [ Time Frame: At inclusion at 14 days and at 28 days ]According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia Microbiological testing [ Time Frame: At inclusion at 14 days and at 28 days ]According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia",50
198,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT03680274,"Number of deceased participants or with persistent organ dysfunction [ Time Frame: Both assessed at 28 days ]Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors","Number of participants with persistent organ dysfunction-free days in intensive care unit [ Time Frame: Up to day 28 ]Persistent organ dysfunction-free days in intensive care unit
Number of participants deceased at 6 months [ Time Frame: 6 months ]Mortality at 6 months
Score of health related quality of life in 6-month survivors [ Time Frame: 6 months ]Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Global tissue dysoxia [ Time Frame: Days 1, 3, 7 ]Assessed by serum lactate concentration
Organ function (including renal function) [ Time Frame: Days 1, 2, 3, 4, 7, 10, 14, 28 ]Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).
Rate of inflammation [ Time Frame: Days 1, 3, 7 ]Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)
Rate of infection [ Time Frame: Days 1, 3, 7 ]Assessed by procalcitonin (PCT)
Rate of endothelial injury [ Time Frame: Days 1, 3, 7 ]Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Number of participants deceased at 6 months [ Time Frame: 6 months ]Mortality at 6 months
Score of health related quality of life in 6-month survivors [ Time Frame: 6 months ]Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Global tissue dysoxia [ Time Frame: Days 1, 3, 7 ]Assessed by serum lactate concentration
Organ function (including renal function) [ Time Frame: Days 1, 2, 3, 4, 7, 10, 14, 28 ]Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).
Rate of inflammation [ Time Frame: Days 1, 3, 7 ]Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)
Rate of infection [ Time Frame: Days 1, 3, 7 ]Assessed by procalcitonin (PCT)
Rate of endothelial injury [ Time Frame: Days 1, 3, 7 ]Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Score of health related quality of life in 6-month survivors [ Time Frame: 6 months ]Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Global tissue dysoxia [ Time Frame: Days 1, 3, 7 ]Assessed by serum lactate concentration
Organ function (including renal function) [ Time Frame: Days 1, 2, 3, 4, 7, 10, 14, 28 ]Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).
Rate of inflammation [ Time Frame: Days 1, 3, 7 ]Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)
Rate of infection [ Time Frame: Days 1, 3, 7 ]Assessed by procalcitonin (PCT)
Rate of endothelial injury [ Time Frame: Days 1, 3, 7 ]Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Global tissue dysoxia [ Time Frame: Days 1, 3, 7 ]Assessed by serum lactate concentration
Organ function (including renal function) [ Time Frame: Days 1, 2, 3, 4, 7, 10, 14, 28 ]Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).
Rate of inflammation [ Time Frame: Days 1, 3, 7 ]Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)
Rate of infection [ Time Frame: Days 1, 3, 7 ]Assessed by procalcitonin (PCT)
Rate of endothelial injury [ Time Frame: Days 1, 3, 7 ]Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Organ function (including renal function) [ Time Frame: Days 1, 2, 3, 4, 7, 10, 14, 28 ]Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).
Rate of inflammation [ Time Frame: Days 1, 3, 7 ]Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)
Rate of infection [ Time Frame: Days 1, 3, 7 ]Assessed by procalcitonin (PCT)
Rate of endothelial injury [ Time Frame: Days 1, 3, 7 ]Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Rate of inflammation [ Time Frame: Days 1, 3, 7 ]Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)
Rate of infection [ Time Frame: Days 1, 3, 7 ]Assessed by procalcitonin (PCT)
Rate of endothelial injury [ Time Frame: Days 1, 3, 7 ]Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Rate of infection [ Time Frame: Days 1, 3, 7 ]Assessed by procalcitonin (PCT)
Rate of endothelial injury [ Time Frame: Days 1, 3, 7 ]Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Rate of endothelial injury [ Time Frame: Days 1, 3, 7 ]Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Occurrence of stage 3 acute kidney injury [ Time Frame: Up to day 28 ]Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Acute hemolysis [ Time Frame: Up to day 28 ]
clinician judgment of hemolysis, as recorded in the chart, OR

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.



Severe hemolysis:
- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry clinician judgment of hemolysis, as recorded in the chart, OR hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin < lower limit of normal at clinical site lab; indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Hypoglycemia [ Time Frame: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose ]Core lab-validated glucose level of less than 3.8 mmol/L
Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Vitamin C volume of distribution [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Vitamin C clearance [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry
Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry Vitamin C plasma concentration [ Time Frame: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) ]Assessed by chromatography-tandem mass spectrometry",800
199,Recruiting,,All,"Child, Adult, Older Adult",NCT04262921,"Clinical features [ Time Frame: 6 months ]Describe the clinical features of the illness or syndrome (cardio-respiratory signs or symptoms, and laboratory results) and complications, and determinants of severity.
Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.
Response to treatment [ Time Frame: 6 months ]Describe the response to treatments (including supportive care and novel therapeutics) by clinical, biological, radiological and virological assessments.
Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.
Pathogen replication, excretion and evolution, within the host [ Time Frame: 6 months ]high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Immune host responses to infection and therapy [ Time Frame: 6 months ]Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Host genetic variants [ Time Frame: Day 1 ]Identify host genetic variants associated with disease progression or severity Response to treatment [ Time Frame: 6 months ]Describe the response to treatments (including supportive care and novel therapeutics) by clinical, biological, radiological and virological assessments.
Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.
Pathogen replication, excretion and evolution, within the host [ Time Frame: 6 months ]high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Immune host responses to infection and therapy [ Time Frame: 6 months ]Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Host genetic variants [ Time Frame: Day 1 ]Identify host genetic variants associated with disease progression or severity Pathogen replication, excretion and evolution, within the host [ Time Frame: 6 months ]high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Immune host responses to infection and therapy [ Time Frame: 6 months ]Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Host genetic variants [ Time Frame: Day 1 ]Identify host genetic variants associated with disease progression or severity Immune host responses to infection and therapy [ Time Frame: 6 months ]Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood.
Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Host genetic variants [ Time Frame: Day 1 ]Identify host genetic variants associated with disease progression or severity Host genetic variants [ Time Frame: Day 1 ]Identify host genetic variants associated with disease progression or severity","Confirmed diagnosis of a pathogen unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen. Refusal by participant, parent or appropriate representative.",500
200,Recruiting,Phase 3,All,"18 Years and older   (Adult, Older Adult)",NCT04308668,"To test if post-exposure prophylaxis with hydroxychloroquine can prevent progression development of symptomatic COVID19 disease after known exposure to the SARS-CoV2 virus. To test if preemptive therapy with hydroxychloroquine can prevent progression of persons with known symptomatic COVID19 disease, preventing hospitalization.","Incidence of COVID19 Disease among those who are asymptomatic at trial entry [ Time Frame: 14 days ]Number of participants at 14 days post enrollment with active COVID19 disease.
Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry [ Time Frame: 14 days ]Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm. Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry [ Time Frame: 14 days ]Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.",3000
201,Not yet recruiting,Phase 1,All,"18 Years to 75 Years   (Adult, Older Adult)",NCT04276987,"Adverse reaction (AE) and severe adverse reaction (SAE) [ Time Frame: Up to 28 days ]Safety evaluation within 28 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)
Time to clinical improvement (TTIC) [ Time Frame: Up to 28 days ]Efficiency evaluation within 28 days, including time to clinical improvement (TTIC) Time to clinical improvement (TTIC) [ Time Frame: Up to 28 days ]Efficiency evaluation within 28 days, including time to clinical improvement (TTIC)","Number of patients weaning from mechanical ventilation [ Time Frame: Up to 28 days ]Number of patients weaning from mechanical ventilation within 28 days
Duration (days) of ICU monitoring [ Time Frame: Up to 28 days ]Duration (days) of ICU monitoring within 28 days
Duration (days) of vasoactive agents usage [ Time Frame: Up to 28 days ]Duration (days) of vasoactive agents using within 28 days
Duration (days) of mechanical ventilation supply [ Time Frame: Up to 28 days ]Duration (days) of mechanical ventilation supply among survivors
Number of patients with improved organ failure [ Time Frame: Up to 28 days ]Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs
Rate of mortality [ Time Frame: Up to 28 days ]Rate of mortality within 28 days Duration (days) of ICU monitoring [ Time Frame: Up to 28 days ]Duration (days) of ICU monitoring within 28 days
Duration (days) of vasoactive agents usage [ Time Frame: Up to 28 days ]Duration (days) of vasoactive agents using within 28 days
Duration (days) of mechanical ventilation supply [ Time Frame: Up to 28 days ]Duration (days) of mechanical ventilation supply among survivors
Number of patients with improved organ failure [ Time Frame: Up to 28 days ]Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs
Rate of mortality [ Time Frame: Up to 28 days ]Rate of mortality within 28 days Duration (days) of vasoactive agents usage [ Time Frame: Up to 28 days ]Duration (days) of vasoactive agents using within 28 days
Duration (days) of mechanical ventilation supply [ Time Frame: Up to 28 days ]Duration (days) of mechanical ventilation supply among survivors
Number of patients with improved organ failure [ Time Frame: Up to 28 days ]Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs
Rate of mortality [ Time Frame: Up to 28 days ]Rate of mortality within 28 days Duration (days) of mechanical ventilation supply [ Time Frame: Up to 28 days ]Duration (days) of mechanical ventilation supply among survivors
Number of patients with improved organ failure [ Time Frame: Up to 28 days ]Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs
Rate of mortality [ Time Frame: Up to 28 days ]Rate of mortality within 28 days Number of patients with improved organ failure [ Time Frame: Up to 28 days ]Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs
Rate of mortality [ Time Frame: Up to 28 days ]Rate of mortality within 28 days Rate of mortality [ Time Frame: Up to 28 days ]Rate of mortality within 28 days",30