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: “For blinding, a statistician who was not involved in the trial did randomization by a computerized randomization table. The investigators and study participants were masked to subgroup assignments until the study was completed.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “For blinding, a statistician who was not involved in the trial did randomization by a computerized randomization table. Participants were randomly assigned (1:1) either to receive FVP or a placebo. The investigators and study participants were masked to subgroup assignments until the study was completed. It was noted that the composition of the drug and placebo was prepared by Beacon Pharmaceuticals Ltd, Dhaka, Bangladesh. In this study, Group-A received oral FPV following recommended dosage twice daily. Group B received a placebo which was indistinguishable from FPV following the same dosage, timing, and duration.”
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: Incidence of viral negative conversion (D7). Clinical improvement (D28). |
| Missing outcome data |
High |
Comment: 57 participants randomized; 50 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons:"Among the patients, 4 from Favipiravir (FVP) group and 3 from the placebo group were discontinued.” No further information is provided. Missingness could depend on the true value of the outcome. No information on whether missingness depended on the true value of the outcome. Risk assessed to be high for the outcomes: Incidence of viral negative conversion (D7). Clinical improvement (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. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28). |
| Selection of the reported results |
Low |
Comment: The registry was available (dated May 26, 2020).
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: Incidence of viral negative conversion (D7). Clinical improvement (D28). |
| Overall risk of bias |
High |