Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

Outcome name:1. Death; 2. Hospitalized; on invasive mechanical ventilation or 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.Measure:Cohort 1 (non-ventilated subjects)Proportion of subjects alive and without respiratory failure at Day 15; where respiratory failure is defined as the need for high flow oxygen (HFO); non-invasive ventilation (NIV); invasive mechanical ventilation (IMV); or extracorporeal membrane oxygenation (ECMO). Respiratory failure status will be evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Subjects whose clinical outcome meets NIAID categories 2 or 3 will be considered as having respiratory failure.Timepoints:Cohort 2 (ventilated subjects)The primary efficacy endpoint is mortality rate; defined as the proportion of subjects who die by Day 15.

Outcome name:1. Death; 2. Hospitalized; on invasive mechanical ventilation or 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.Measure:Cohort 1 (non-ventilated subjects)Proportion of subjects alive and without respiratory failure at Day 15; where respiratory failure is defined as the need for high flow oxygen (HFO); non-invasive ventilation (NIV); invasive mechanical ventilation (IMV); or extracorporeal membrane oxygenation (ECMO). Respiratory failure status will be evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Subjects whose clinical outcome meets NIAID categories 2 or 3 will be considered as having respiratory failure.Timepoints:Cohort 2 (ventilated subjects)The primary efficacy endpoint is mortality rate; defined as the proportion of subjects who die by Day 15.