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: "Randomization was performed by one of the investigators through the web-based system using randomly permuted blocks in a 1:1 ratio (Supplementary Appendix). The investigator who performed the randomization was not involved in the dispensing of the medication, inclusion, and follow-up of the patients"
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance |
| Deviations from intervention |
Low |
Quote: "The investigator who performed the randomization was
not involved in the dispensing of the medication, inclusion,
and follow-up of the patients. The rest of the investigators
were blinded to the treatment received, as were
the patients" (report) "Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" (registry)
Comment: Blinded study (participants and personnel/carers). Data for the outcome were analyzed using 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).Time to death. Hospitalization or death (D28). Incidence of viral negative conversion (D7).WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 501 participants randomized; 501 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28).Time to death. Hospitalization or death (D28). Incidence of viral negative conversion (D7).WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| 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).Time to death. Hospitalization or death (D28). Incidence of viral negative conversion (D7).WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan (prospective, dated 17 August 2020), and registry (retrospective, dated 27 August 2020) were available.
MORTALITY, INCIDENCE OF VIRAL NEGATIVE CONVERSION, ADVERSE EVENTS< SRIOUS ADVERSE EVENTS Outcomes pre-specified. 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 outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Adverse events. Serious adverse events. HOSPITALIZATION OR DEATH, TIME TO DEATH, WHO SCORE 7 AND ABOVE, TIME TO WHO SCORE 7 Outcome data acquired from contact with authors. 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: . Hospitalization or death (D28). Time to death. WHO score 7 and above (D28). Time to WHO score 7 and above |
| Overall risk of bias |
Low |