Number of Therapeutic Oxygen-Free Days
Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.
Length of Hospital Stay
Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm
Viral Clearance by Nasopharyngeal Swab
Nasopharyngeal swabs will be collected every second day for the duration of study participation. Viral clearance is measured as fold change in viral genetic copies per mL
Difference in Estimated P/F Ratio at 14 days
Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available.
Difference in Plasma Neutrophils at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Plasma Lymphocytes at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Plasma Monocytes at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Plasma C-Reactive Protein (CRP) at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Plasma IL-6 at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Plasma Procalcitonin (PCT) at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Plasma Ferritin at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in NLR (Neutrophils to Lymphocytes Ratio) at 14 days
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
14-Day Mortality
Outcome reported as the number of participants who have expired at 14 days post enrollment.
Difference in Organ Injury Plasma markers at 14 days - Lactate
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Organ Injury Plasma markers at 14 days - Cardiac Troponin (TRO)
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Organ Injury Plasma markers at 14 days - Creatine Kinase (CK)
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Organ Injury Plasma markers at 14 days - Alanine Aminotransferase (ALT)
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Organ Injury Plasma markers at 14 days - Alkaline Phosphatase (ALP)
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Organ Injury Plasma markers at 14 days - D-dimer
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Difference in Organ Injury Plasma markers at 14 days - Platelets (PLT)
Blood will be collected every second day for the duration of study participation. Difference will be calculated based on the first measurement after admission to the study.
Number of Abnormal Biomarker Days - D-dimer
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Neutrophils
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Lymphocytes
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Platelets (PLT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Monocytes
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - C-Reactive Protein (CRP)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - IL-6
Outcome reported as the mean number of days participants in each arm had 2 or more abnormal plasma levels.
Number of Abnormal Biomarker Days - Procalcitonin (PCT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Lactate
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Cardiac Troponin (TRO)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Creatine Kinase (CK)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Alanine Aminotransferase (ALT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Alkaline Phosphatase (ALP)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Number of Abnormal Biomarker Days - Ferritin
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Difference in Oxygenation at 14 days
PaO2 or SaO2 and FiO2. Partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry. FiO₂ is estimated from oxygen flow/delivery rates
Difference in Estimated PEEP adjusted P/F Ratio at 14 days
Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio) and Expiratory Pressure.
Daily Hypotensive Episodes
Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL, new treatment with pressures, increase in 50% pressure or fluid rate) per participant in each arm.
Hypotension Requiring Vasopressors
Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Acute Kidney Injury
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.
Sequential Organ Failure Assessment (SOFA) Total Score
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 risk of mortality.
Oxygen Saturation / Fractional Inhaled Oxygen (F/S)
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.
28-Day Mortality
Outcome reported as the number of participants who have expired at 28 days post enrollment.
90-Day Mortality
Outcome reported as the number of participants who have expired at 90 days post enrollment.
ICU Admission
Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
Number of Ventilator-Free Days
Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Number of Vasopressor-Free Days
Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.
Length of ICU Stay
Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Incidence of Respiratory Failure
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.
Change in PROMIS Dyspnea Functional Limitations
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
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.
Disease Severity Rating
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.
Viral Load by Nasopharyngeal Swab
Nasopharyngeal swabs will be collected every fourth day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Viral Load by Blood
Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Viral Clearance by Blood
Blood will be collected every third day for viral load assessment for the duration of study participation. clearance is measured as fold change in viral genetic copies per mL.
Abnormal Biomarkers after recovery - D-dimer
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Neutrophils
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Lymphocytes
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Platelets (PLT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Monocytes
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - C-Reactive Protein (CRP)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - IL-6
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Procalcitonin (PCT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Lactate
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Cardiac Troponin (TRO)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Creatine Kinase (CK)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Alanine Aminotransferase (ALT)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Alkaline Phosphatase (ALP)
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Biomarkers after recovery - Ferritin
Outcome reported as the mean number of days participants in each arm had abnormal plasma levels.
Abnormal Oxygenation after recovery
Outcome reported as the mean number of participants in each arm had abnormal PaO2 or SaO2 and FiO2 levels at the end of quarantine period. Partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry. FiO₂ is estimated from oxygen flow/delivery rates
PROMIS Dyspnea Functional Limitations after recovery
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. Measured at the end of quarantine period.
PROMIS Dyspnea Severity after recovery
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. Measured at the end of quarantine period.