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: “Randomized using a secure, in-house, web-based randomization system.”
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: “Open-label”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. In the outpatient setting, we consider no important cointerventions of interest. Hence, no deviation 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 low for the outcome: Mortality (D28). Hospitalization or death. WHO score 7 and above (D28). |
| Missing outcome data |
Some concerns |
Comment: Number of patients concurrently randomized unclear for usual care arm, 1073 randomized for treatment arm; 990 patients analyzed for treatment arm, 987 analyzed for control arm. Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons for missing data: not eligible (16 vs unknown); withdrew consent (10 vs unknown); recovered at day 0 (3 vs unknown); no outcome diary information (54 vs unknown) Missingness could depend on the true value of the outcome. Not likely that missingness depends on the true value of the outcome. Proportions of missing data do not correspond with the number of participants analysed in the control group. Risk assessed to be some concerns for the outcome: Mortality (D28). Hospitalization or death. 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 outcomes: Mortality (D28). HOSPITALIZATION OR DEATH, WHO SCORE 7 AND ABOVE For the outcome hospitalization or death, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcome: Hospitalization or death. WHO score 7 and above (D28) |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan (retrospective, dated 22nd February, 2021) and registries (prospective, dated 25th and 22nd March, 2020) were available.
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: Mortality (D28). Hospitalization or death. WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |