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|
|Quote: "Patients were randomized into three cohorts"
Comment: Allocation sequence probably random. No information on allocation concealment
|Deviations from intervention||
|Quote: “Open label”
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context:
No participant cross-over.
No information on administration of co-interventions of interest: biologics and antivirals. Corticosteroids were reported and balanced between groups.
Hence, no information on whether deviations arose because of the trial context.
Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Risk assessed to be some concerns for the outcomes: Mortality (D28). Adverse events. Serious adverse events.
|Missing outcome data||
|Comment: 39 participants randomized; 39 participants analyzed.
Data available for all or nearly all participants randomized.
Risk assessed to be low for the outcome: Mortality (D28). Adverse events. Serious adverse events.
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unblinded study (outcome assessor)
Observer-reported outcome not involving judgement.
Risk assessed to be low for the outcomes: Mortality (D28)
ADVERSE AND SERIOUS ADVERSE EVENTS
The authors reported on adverse and serious adverse events that may contain both clinically- and laboratory-detected events, 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 outcomes: Adverse events. Serious adverse events.
|Selection of the reported results||
|Comment: The protocol, statistical analysis plan and registry were not available
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
No information on whether the trial was analyzed as pre-specified.
Mortality outcome was not pre-specified, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned.
Risk assessed to be low for the outcome: Mortality (D28)
Risk assessed to be some concerns for the outcomes: Adverse events. Serious adverse events
|Overall risk of bias||