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 unrestricted (no blocking or stratification), and the sequence was generated by the study’s unmasked data team using a computergenerated pseudo-random number generator in R" "Allocation was concealed by not revealing the letter randomly assigned to the participant until after enrollment and baseline assessments were complete."
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote:“Participants, investigators, and study staff were masked to treatment randomization.”
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. Adverse events. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 263 participants randomized; 217 participants analyzed for safety; 197 for efficacy.
Data not available for all or nearly all participants randomized; 17% missing for safety (day 3) and 25% missing for efficacy (day 21). No evidence that the result is not biased. Reasons: safety: lost to follow-up: 13.5% vs. 15.2%, missing outcome data: 1.8% vs. 6.5%; efficacy: lost to follow-up: 26.9% vs. 21.7%. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome. Risk assessed to be some concerns for the outcomes: Mortality (D28). Hospitalization or death. 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: Mortality (D28). Hospitalization or death. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, and registry (dated 2 April 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 outcomes: Mortality (D28). Hospitalization or death. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |