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|
|Report: “randomized (1:1) via balanced block randomization into treatment and non-treatment (standard) groups [39 persons per each group] by epidemiologists of the study”
Registry: "Simple randomization will be generated with a computer from 1 to 60. The computer will divide the digits between the two groups."
Comment: Allocation sequence random. No information on allocation concealment.
|Deviations from intervention||
|Quote: "Clinicians and patients were not blind to treatment assignment."
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: antivirals, corticosteroids, biologics.
Hence, no information on whether deviations arose because of the trial context.
Data for the outcome were analyzed using 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.
|Missing outcome data||
|Comment: 78 participants randomized; 78 participants analyzed.
Data available for all participants.
Risk assessed to be low for the outcomes: Mortality (D28). 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)
Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for the outcome: Mortality (D28).
Adverse events can contain both clinically- and laboratory-detected events and 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 prospective registry was available.
Outcomes not specified in the registry.
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
Trial probably not analyzed as pre-specified.
Risk assessed to be some concerns for the outcome: Mortality (D28). Adverse events.
|Overall risk of bias||