Table 1 Trial outcomes. Definitions for all outcome are provided in the statistical analysis plan available in the Supplementary Materials
Outcomes | Variable type | Approach to analysis |
|---|---|---|
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 days 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 |