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 (participants and personnel/carers). Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 1033 participants randomized; 1033 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. WHO score 7 and above (D28). 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: Method of measuring the outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Time to death. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The prospective protocol (dated April 19th, 2020), statistical analysis plan, retrospective registry (dated May 26th, 2020) were available.
Outcomes pre-specified. 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 (D28). Time to death. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
Low |