| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Report:
“Participants were assigned to the intervention or control groups using blocked randomization method. Envelopes were prepared for unmasking. The random allocation procedure was performed by an independent staff of the hospital of RCT setting. The project manager and other colleagues of our study enrolled and assigned participants to interventions” Registry: "Allocation concealment will be done by numbered drug cans that are numbered randomly. The cans will be the same weight and shape and will be prepared by an independent researcher." Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: "open label randomized controlled trial"
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: antivirals, corticosteroids, biologics. Appropriate analysis method used; participants analyzed according to assigned intervention. |
| Missing outcome data |
Low |
Comment: 100 patients randomized; 100 patients analyzed.
Data available for all participants.
Risk assessed to be low for the outcomes: Mortality. Adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality Adverse events may contain both clinically- and laboratory-detected outcomes which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcome: Adverse events. |
| Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was available and utilized.
Mortality was registered and reported as an outcome in the paper. Adverse events were not listed as an outcome in registration, nor reported as one in the paper. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial was probably analyzed as pre-specified. Risk assessed to be low for outcome: Mortality. Adverse events. |
| Overall risk of bias |
Some concerns |