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: "Using a permuted block (block size 2 or 4) method and
stratifying by site, participants were randomly
assigned (1:1) to receive either molnupiravir plus
standard of care or placebo plus standard of care. The
randomisation sequence was generated by use of STATA (version 16) by an independent statistician (who had no
further involvement in the trial) and used to prepare
labelled placebo and treatment packs, which were
assigned sequentially to patients on randomisation."
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Comment: Blinded study (participants and personnel/carers) Our analysis for the 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: Hospitalization or death. Mortality (D28). Incidence of viral negative conversion (D7). Time to viral negative conversion. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 180 participants randomized; 180 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Hospitalization or death. Mortality (D28). Incidence of viral negative conversion (D7). Time to viral negative conversion. WHO score 7 and above (D28). 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. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan and registries were available (earliest registration in EudraCT was prospective, 14 March 2020).
Outcome 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: Hospitalization or death. Mortality (D28). Incidence of viral negative conversion (D7). Time to negative conversion. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
Low |