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 variable block randomization stratifed based on disease severity (mild or moderate illness) was done using a centralized telephone-based system"
Quote (registry): "Sequentially numbered, sealed, opaque envelopes" Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: "patients, investigators, caregivers, and statisticians were blinded to the allocation."
Comment: Blinded study (participants and personnel/carers). Participants were analyzed according to their randomized groups for the outcome. Of note, 5 participants (unclear distribution/proportion between arms) were excluded from the analysis of safety outcomes post-randomization due to withdrawn consent. This method was considered appropriate to estimate the effect of assignment to intervention. A further 20 vs 7 participants were excluded from the analysis of clinical improvement and viral negative conversion outcome post-randomization due to non-positive PCR result on day of enrolment (exclusion criteria). This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 157 patients randomized; 152 patients analyzed for adverse events, WHO score 7 and above, mortality; 125 patients analyzed for clinical improvement; 114 patients analyzed for viral negative conversion at D7.
Data available for all or nearly all participants for adverse and serious adverse events, WHO score 7 and above, mortality. Data not available for all or nearly all participants for clinical improvement because patients with negative PCR test at baseline (exclusion criteria) were excluded from the analysis. No evidence that the result is not biased. Missingness could not depend on the true value of the outcome. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. Data not available for all or nearly all participants for viral negative conversion: 20% with negative PCR test at baseline (exclusion criteria) were excluded from the analysis and an additional 7% was due to unavailable results. Missingness could depend on the true value of the outcome, but it not considered likely to. Risk assessed to be some concerns for the outcome: Incidence of viral negative conversion (D7). |
| 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). Incidence of viral negative conversion (D7). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available.
No outcomes were pre-specified. 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 outcome: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |