Trial NCT04401579
Publication Kalil A, N Engl J Med, 2020
Primary outcome on the report: Time to recovery, with the day of recovery defined as the first day, during the 28 days after enrollment, on which a patient attained category 1, 2, or 3 on the eight-category ordinal scale

Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.

Bias Author's judgement Support for judgement
Randomization
Low 		Quote: “Randomization was stratified by study site and disease severity at enrollment and was performed using a web-based Internet Data Entry System, Advantage eClinical”
Comment: Allocation sequence random. Allocation sequence concealed
Imbalances in baseline characteristics appear to be compatible with chance
Deviations from intervention
Low 		Quote: “Randomized double-blind placebo-controlled trial” Quote: "The trial team was unaware of the trial-group assignments until after all data queries were resolved and the database was locked." Quote: "Matching oral placebo was administered according to the same schedule as the active drug. IV bags of study treatment (both the Active and the Placebo) will be covered to mask the slight color difference between the remdesivir solution and placebo to maintain the study blind."
Comment: Blinded study (patients and physicians).
Data were analyzed using intention-to-treat analysis.
Missing outcome data
Low 		Comment: 1033 patients randomized; 1033 patients analyzed.
Data available for entire population.
Risk assessed to be low for the outcomes: Mortality. Time to death. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events.
Measurement of the outcome
Low 		Quote: "The trial team was unaware of the trial-group assignments until after all data queries were resolved and the database was locked."
Comment: Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Mortality. Time to death. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events.
Selection of the reported results
Low 		Comment: The protocol, statistical analysis plan, registry were available.
Results were not selected from multiple outcome measurements or analyses of the data.
Trial analyzed as pre-specified.
Risk assessed to be low for the outcomes: Mortality. Time to death. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events.
Overall risk of bias
Low