| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "Participants were randomized (1:1) using a computer-generated random-number list". Quote: "Random allocation was done remotely by a member of the study team not involved in participants’ enrollment." Comment: Baseline characteristics between intervention groups were comparable; any differences appear to be compatible with chance. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study. No participant cross-over. No information on review co-interventions of interest: antivirals, glucocorticoids, antimalarials and biologics. Outcome data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Quote: "Additionally, 60 (8.0%) participants were finally excluded from ITT analysis because of negative RT-PCR at baseline, missing RT-PCR at all follow-up visits, or consent withdrawal, yielding an ITT population of 293 Covid-19 patients" Comment: 353 randomized, 293 analyzed. Data was unavailable for more than 10% of those randomized. However, all missing data occurred due to documented reasons unrelated to the outcome. Risk assessed to be low for outcomes: Mortality. Incidence of Recovery. Incidence of WHO score 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Mortality is an observer-reported outcome not involving judgement. Incidence of WHO score 7 and above is an outcome that reflects decisions made by the intervention provider. However, we consider that the assessment of these outcomes cannot possibly be influenced by knowledge of the intervention assignment. Risk assessed to be low for outcomes: Mortality. Incidence of WHO score 7 and above. For Incidence of 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. Adverse events and 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: Recovery. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. Risk assessed to be some concerns for the outcomes: Mortality. Incidence of recovery. Incidence of WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |