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 (protocol): “According to the randomization schedule as indicated in the Schedule of Assessments (Table 1), the investigator or designee will obtain the randomization number from the IWRS software."
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)”
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: Hospitalization or death. Mortality (D28). Incidence of viral negative conversion (D7). Serious adverse events. |
| Missing outcome data |
Low |
Comment: 295 participants randomized; 295 participants analyzed for efficacy outcomes, 294 analyzed for safety outcomes.
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). 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). Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol (Oct 7, 2020), statistical analysis plan (Mar 31, 2021), and registry consulted up to version dated Nov 10, 2020 were available.
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). Serious adverse events. |
| Overall risk of bias |
Low |