| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "randomly assigned in a 1:1:1 ratio to receive up to a 5-day course of remdesivir, up to a 10-day course of remdesivir, or standard care. Randomization was not stratified. The randomization list was created and validated by the interactive web response system (IWRS) vendor. A dummy randomization list was provided in Microsoft Excel format to the biostatistician employed by the study sponsor for review. A separate list of sequential patient numbers within each treatment group was generated by the IWRS vendor. The randomization had a block size of 6. Based on the treatment from the randomization list, the IWRS provided the next sequential patient number to the site along with the treatment group assignment. The appropriate number of vials of open-label study drug were assigned to the patient. Sites did not have access to the randomization list and could not know the sequence of treatments." Comment: Allocation sequence concealed. Any imbalance in the baseline characteristics is compatible with chance. |
| Deviations from intervention |
Low |
Comment: Unblinded study.
No participant cross-over Co-intervention of interest: antivirals, corticosteroids and biologics were reported and balanced across arms. Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 596 randomized/584 analyzed. Risk assessed to be low for the outcomes: Mortality. Time to death. Clinical Improvement. Time to clinical improvement. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Open label trial. Mortality is an observer-reported outcome not involving judgement. For the outcome WHO score 7 or above (intubation or death) and Serious adverse events (when it includes events not involving judgement e.g., laboratory measures), We consider that the assessment cannot possibly be influenced by knowledge of the intervention assignment. Risk assessed to be low for outcomes: Mortality. Time to death. WHO score 7 and above. Serious adverse events. For the outcomes Clinical improvement, Time to clinical improvement, WHO score 6 and above, although the assessment could possibly be influenced by knowledge of the intervention assignment, we did not consider this likely to have happened in the context of a pandemic. The same applies to the outcome Adverse events when the outcome includes patient or observer reported events. Risk assessed to be some concerns for outcomes: Clinical improvement. Time to clinical improvement. WHO score 6 and above. Adverse events. |
| Selection of the reported results |
Low |
Comment: Protocol and statistical plan available. Data analysed and presented according to a pre-specified plan. Risk assessed to be low for the outcomes: Mortality. Time to death. Clinical Improvement. Time to clinical improvement. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |