Efficacy outcomes |
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale 14 days after randomization (assessed on Study Day 15) |
Ordinal |
Cumulative probability model with logit link |
All-location, all-cause 14-day mortality (assessed on Study Day 15) |
Binary |
Logistic regression |
All-location, all-cause 28-day mortality (assessed on Study Day 29) |
Binary |
Logistic regression |
Survival through 28 days |
Time-to-event |
Proportional hazards regression |
Time to hospital discharge through 28 days |
Time-to-event |
Multistate model with death as a competing risk |
Time to recovery |
Time-to-event |
Cumulative probability model with logit link |
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3, 8 and 29 |
Ordinal |
Cumulative probability model with logit link |
Oxygen-free days through Day 28 |
Ordinal |
Cumulative probability model with logit link |
Ventilator-free days through Day 28 |
Ordinal |
Cumulative probability model with logit link |
Vasopressor-free days through Day 28 |
Ordinal |
Cumulative probability model with logit link |
ICU-free days through Day 28 |
Ordinal |
Cumulative probability model with logit link |
Hospital-free days through Day 28 |
Ordinal |
Cumulative probability model with logit link |
Safety Outcomes |
Receipt of renal replacement therapy |
Binary |
Risk difference |
Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) |
Binary |
Risk difference |
Cardiovascular event (myocardial infarction or ischemic stroke) |
Binary |
Risk difference |
Transfusion reaction |
Binary |
Risk difference |
Transfusion related acute lung injury (TRALI) |
Binary |
Risk difference |
Transfusion associated circulatory overload (TACO) |
Binary |
Risk difference |
Transfusion-related infection |
Binary |
Risk difference |