|Bias||Author's judgement||Support for judgement|
“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”
"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||
|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 and anticoagulants.
Appropriate analysis method used; participants analyzed according to assigned intervention.
|Missing outcome data||
|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||
|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||
|Comment: Neither the protocol nor the statistical analysis plan was available.
The secondary outcome of mortality as reported in the pre-print article was added to the trial registration after study completion. Adverse events were not reported as an outcome in registration.
Mortality data was likely not selected from multiple outcome measurements or analyses of the data. Trial was probably not analyzed in accordance with a pre-specified plan, with respect to mortality outcome.
No information on whether adverse event data were selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified, with respect to this outcome (adverse events).
Risk assessed to be some concerns for the outcomes: Mortality. Adverse events.
|Overall risk of bias||