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: "A central randomization website generated treatment allocations 1:1 between intervention and placebo"
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "Apart from statisticians preparing the randomization schema, all other study members including participants, research personnel, and clinical teams were blinded"
Comment: Blinded study (participants and personnel/carers). Data for the outcomes 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 outcome: Mortality (D28). Hospitalization or death. |
| Missing outcome data |
Low |
Comment: 117 participants randomized; 117 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death |
| 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 outcome: Mortality (D28). Hospitalization or death. |
| Selection of the reported results |
Low |
Comment: The prospective trial registry was available (earliest version dated March 13th, 2020; version consulted dated April 9th, 2020).
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. Hospitalization was pre-specified. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). Hospitalization or death. |
| Overall risk of bias |
Low |