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 |
Some concerns |
Quote: “patients were randomly assigned”
Comment: Allocation sequence probably random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “Open label”
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: antivirals and biologics. Some corticosteroid administration was reported (4 participants in the chloroquine group received methylprednisone due to worsening condition. Use of methylprednisone in the favipiravir group was not explicitly reported). Hence, no information on whether deviations arose because of the trial context. 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 some concerns for the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 96 participants randomized; 92 participants analyzed.
Data available for all or nearly all participants. Risk assessed to be low for the outcome: Mortality (D28). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor). Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available.
Study outcomes in the registry were changed at or near study completion. Mortality had not been a pre-specified outcome (in the first version of the registry dated April 15th, 2020) but was in the final version of registry dated September 25th, 2020. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |