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: “Randomization was conducted using a custom-developed online tool to allow for dynamic randomization and allocation concealment.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "All participants and the research team were blinded except for the research pharmacist and randomization website programmer."
Comment: Blinded study (participants and personnel/carers) Data for the outcome were analyzed using 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). Hospitalization or death. WHO score 7 and above (D28). Serious adverse events. |
| Missing outcome data |
Low |
Comment: 148 participants randomized; 148 participants analyzed.124 analyzed for safety
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death (D28). Hospitalization (D28). WHO score 7 and above (D28).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). Hospitalization or death (D28). Hospitalization (D28). WHO score 7 and above (D28). Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol(retrospective, May 1st ,2020), statistical analysis plan (retrospective, April 27th ,2020) and registry (prospective, April 1st, 2020) were available
MORTALITY, HOSPITALIZATION AND DEATH, WHO SCORE 7 AND ABOVE 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: Mortality (D28). Hospitalization or death (D28). Hospitalization (D28). WHO score 7 and above (D28). SERIOUS ADVERSE EVENT Outcome not pre-specified in the prospective registry. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Serious adverse events. |
| Overall risk of bias |
Some concerns |