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 |
Some concerns |
Quote: “Participants were randomly assigned in a 1:1:1 ratio. Randomisation was computer-generated in permuted blocks with a stratification based on site.”
Comment: Allocation sequence random. No information on allocation concealment. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Some concerns |
Quote: "single-blind... Patients were masked".
Comment: Unblinded study (personnel/carers). Deviations from intended intervention arising because of the study context: No information on participant cross-over. In the outpatient setting, we consider no important cointerventions of interest. Hence, not all information available on whether deviations arose because of the trial context. 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 some concerns for the outcomes: Hospitalisation or death. Mortality (D28). WHO score 7 and above (D28). |
| Missing outcome data |
Low |
Comment: 319 participants randomized; 311 participants analyzed.
Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: Hospitalization or death. Mortality (D28). WHO score 7 and above (D28). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor). MORTALITY Observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). HOSPITALIZATION OR DEATH and WHO SCORE 7 AND ABOVE For this outcome, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: Hospitalization or death. WHO score 7 and above (D28). |
| Selection of the reported results |
Some concerns |
Comment: The registry was retrospective (dated January 25, 2022).
HOSPITALIZATION OR DEATH. WHO SCORE 7 AND ABOVE. No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Hospitalization or death. WHO score 7 and above (D28). MORTALITY Mortality outcome was not pre-specified as the registry is retrospective, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. 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). |
| Overall risk of bias |
Some concerns |