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: "Starting from the first patient included in the study, patients with odd numbers were grouped as the study group, and patients with even numbers as the control group"
Comment: Allocation sequence random. Allocation sequence not concealed.
|Deviations from intervention||
|Quote: "single-blind randomized method"
Comment: Single-blinded study (unclear if participants or personnel/carers were blinded)
Deviations from intended intervention arising because of the study context:
No participant cross-over.
Co-interventions of interest: antivirals were administered as part of standard care. No information on biologics and corticosteroids.
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 (D60 or more). Incidence of viral negative conversion (D7). Adverse events. Serious adverse events.
|Missing outcome data||
|Comment: 66 participants randomized; 66 participants analyzed for mortality and safety; 24 participants analyzed for negative viral conversion.
Data available for all participants randomized for safety.
Risk assessed to be low for the outcomes: Mortality (D60). Adverse events. Serious adverse events.
Data not available for all or nearly all participants randomized for negative viral conversion.
No evidence that the result is not biased.
Reasons for missing data: gene mutation putting participant at risk of serious adverse events (n=6 in intervention group); no reasons reported for the remaining 14 vs 22 participants missing.
No information on whether missingness could or likely to depend on the true value of the outcome.
Risk assessed to be high for the outcome: Incidence of viral negative conversion (D7).
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unclear blinding (outcome assessor).
Mortality and viral negative conversion are observer-reported outcomes not involving judgement.
Risk assessed to be low for the outcome: Mortality (D60 or more). Incidence of viral negative conversion (D7).
Adverse events and serious adverse events may contain both clinically- and laboratory-detected events. Both these outcomes 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 prospective protocol (dated May 4th, 2020), statistical analysis plan, and retrospectively registered trial registry were available.
MORTALITY, ADVERSE and SERIOUS ADVERSE EVENTS
Results were not selected from multiple outcome measurements or analyses of the data for mortality and adverse events.
Trial analyzed as pre-specified.
Risk assessed to be low for the outcomes: Mortality (D60 or more). Adverse events. Serious adverse events.
VIRAL NEGATIVE CONVERSION
Outcome not pre-specified.
No information on whether the result for viral negative conversion was selected from multiple outcome measurements or analyses of the data.
Trial not analyzed as pre-specified.
Risk assessed to be some concerns for the outcome: Incidence of viral negative conversion (D7).
|Overall risk of bias||