| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "Eligible subjects were randomly assigned by an interactive web response system in a 2:1 ratio to receive either HCQ plus standard of care (SOC) or SOC alone" Quote from contact with authors: "After informed consents signed, a random number were generated by computer" Comment: Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No cross-over. Co-intervention administration of corticosteroids, antivirals and anticoagulants are reported. No information on biologics. Analysis was performed on the total number of randomized patients per group. |
| Missing outcome data |
Low |
Comment: More than 5% of missing data per arm (two in the HCQ group and one in the SOC group). Reason: "withdrawn consents before the first dose was administered".
Missingness due to documented reasons unrelated to the outcome. Risk assessed to be low for outcomes: Mortality. Incidence of viral negative conversion. Time to viral negative conversion. Incidence of recovery. Time to recovery. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Mortality and viral negative conversion are observer-reported outcomes not involving judgement. WHO Score 7 and above reflect decisions made by the intervention provider. However, we consider that the assessment of mortality, WHO Score 7 and above and viral negative conversion cannot possibly be influenced by knowledge of the intervention assignment. Risk assessed to be low for outcome: Mortality. Incidence of viral negative conversion. Incidence of WHO score 7 and above. For Incidence of and time to recovery, our assessment depended on the definition used for recovery. Complete resolution of COVID-19-related symptoms is the definition, therefore, although the assessment could possibly be influenced by knowledge of the intervention assignment, we did not consider this likely to have happened in the context of a pandemic. For Score 6 and above, although the assessment could possibly be influenced by knowledge of the intervention assignment, we also did not consider this likely to have happened in the context of a pandemic. Serious adverse events may contain both clinically- and laboratory-detected outcomes, therefore it can be influenced by knowledge of the intervention assignment, but is not likely to. Risk assessed to be some concerns for outcomes: Incidence of recovery. Time to recovery. Incidence of WHO score 6 and above. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Statistical analysis plan not available. Risk assessed to be some concerns for outcomes: Mortality. Incidence of viral negative conversion. Time to viral negative conversion. Incidence of recovery. Time to recovery. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |