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: “Participants were randomized 1:1 to favipiravir or placebo using block, REDCap-implemented,
115 randomization stratified by age (>=50 and <50 years old) and sex.”
Comment: Allocation sequence random. Allocation sequence concealed |
| Deviations from intervention |
Low |
Quote: “doubled blinded - participants and investigators”
Comment: Blinded study (participants and personnel/carers) HOSPITALIZATION OR DEATH. MORTALITY. ADVERSE AND SERIOUS ADVERSE EVENTS. Our analysis for the binary outcomes 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: Hospitalization or death. Mortality (D28). Adverse events. Serious adverse events. (TIME TO) VIRAL NEGATIVE CONVERSION Participants were analyzed according to their randomized groups for the negative conversion outcomes. Of note, 17 (Placebo) versus 16 (Favipiravir) participants were excluded from the analysis post-randomization because RT-PCR tests were negative on days 1-3. This method was considered appropriate to estimate the effect of assignment to intervention for this outcome. Risk assessed to be low for the outcomes: Incidence of viral negative conversion (D7). Time to viral negative conversion. |
| Missing outcome data |
Some concerns |
Comment: 149 participants randomized; 130 participants analyzed (with full follow up).
Data not available for all or nearly all participants randomized No evidence that the result is not biased. Reasons: 4 in each arm were lost to follow up; 2/74 in the placebo arm withdrew for personal reasons; 5/75 in the treatment arm withdrew for personal reasons, 3 for medication intolerance, 1 declined the intervention. 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). Hospitalization or death. 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: Hospitalization or death. Mortality (D28). Incidence of viral negative conversion (D7). Time to viral negative conversion. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The registry was available (dated April 15, 2020).
(TIME TO) VIRAL NEGATIVE CONVERSION 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 outcome: Incidence of viral negative conversion (D7). Time to viral negative conversion. MORTALITY 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. Risk assessed to be low for the outcome: Mortality (D28). HOSPITALIZATION OR DEATH. ADVERSE AND SERIOUS ADVERSE EVENTS. Outcomes not prespecified. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Hospitalization or death. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |