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: "Computer-generated randomisation list (Enov Clinical®) was centralised and stratified according to the center and the time since the COVID-19 symptoms started (1 to 4 days and 5 to 7 days). The permuted block of size 4 randomisation sequence was prepared by a statistician not involved in the trial using SAS software, version 9.4. After checking eligibility, a trial coordinator assigned participants to a treatment group".
Comment: Allocation sequence random /probably random. Allocation sequence concealed. |
| 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 crossover. 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 outcomes: Mortality (D28). Hospitalization or death. WHO score 7 and above (D28). |
| Missing outcome data |
Low |
Comment: 60 participants randomized; 60 participants analyzed.
Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. WHO score 7 and above (D28). |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor). MORTALITY Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). Hospitalization or death, HOSPITALIZATION OR DEATH Hospitalization requires clinical judgement and could be affected by knowledge of intervention receipt, but it is not considered likely in the context of a pandemic. Risk assessed to be some concerns for the outcome: Hospitalization or death. WHO SCORE 7 AND ABOVE For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcome: WHO score 7 and above (D28). |
| Selection of the reported results |
Low |
Comment: The trial registry was available (dated December 28, 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. 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 outcomes: Mortality (D28). Hospitalization or death. WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |