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: "Patients were randomized in a 1:1 ratio to oral favipiravir or placebo. The randomization schedule was generated using the PLAN Procedure (SAS) with a block size of four, stratified by study site. The generated list was embedded in the Research Electronic Data Capture (REDCap) system to ensure allocation concealment."
Comment: Allocation sequence random Allocation sequence concealed |
| Deviations from intervention |
Low |
Quote: “Participants, investigators, and study staff remained unaware of the treatment assignment. The Sponsor’s investigational drug unit, which is not part of the study team, held the information for treatment allocation.”
Comment: Blinded study (participants and personnel/carers) Our analysis for the binary outcome is an 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). Incidence of viral negative conversion (D7). Time to viral negative conversion. Adverse events. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 245 participants randomized; 231 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 7.4% vs. 3.3% withdrew consent; 0.8% vs.0.0% randomized in error (not eligible). Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome Risk assessed to be some concerns for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Time to viral negative conversion. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
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). Incidence of viral negative conversion (D7). Time to viral negative conversion. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, and registry were available.
Mortality outcome was not pre-specified in the registry, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified Risk assessed to be low for the outcome: Mortality (D28). Incidence of viral negative conversion (D7). Time to viral negative conversion. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |