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 stratified 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 |
Low |
Quote: "patients, investigators, caregivers, and statisticians were blinded to the allocation."
Comment: Blinded study (participants and personnel/carers). MORTALITY, CLINICAL IMPROVEMENT, WHO SCORE 7 AND ABOVE, AE, SAE 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 outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. VIRAL NEGATIVE CONVERSION Participants were analyzed according to their randomized groups for the outcome. Of note, 32 vs 11 participants were excluded from the analysis post-randomization due to missing data (12 vs 4) which is accounted for in domain 3, as well as baseline RT-PCR negative (20 vs 7) which is an exclusion criterion. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for outcomes: Incidence of viral negative conversion (D7). |
| Missing outcome data |
Some concerns |
Comment: 157 participants randomized; 152 participants 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.
MORTALITY, WHO SCORE 7 AND ABOVE, AE, SAE Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. CLINICAL IMPROVEMENT 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: Clinical improvement (D28). VIRAL NEGATIVE CONVERSION Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 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 |