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: "Randomization was performed using computer-generated random allocation cards."
Comment: Allocation sequence random. No information on allocation concealment.
|Deviations from intervention||
|Quote: "Despite the fact that the initial study design included blinded groups and was placebo controlled, said structure was not accepted by patients"
"Only the researchers that evaluated treatment effectiveness through instruments answered by the patients, and those that performed the statistical analyses were blinded."
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context:
No participant cross-over.
Administration of co-interventions of interest (antivirals, corticosteroids) was reported. No information on biologics.
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 outcome: Mortality (D28).
|Missing outcome data||
|Comment: 242 participants randomized; 214 participants analyzed.
Data not available for all or nearly all participants randomized.
No evidence that the result is not biased.
Reasons: declined to participate (16), did not meet inclusion criteria (9), discontinued intervention (3).
Missingness could depend on the true value of the outcome.
Not likely that missingness depended on the true value of the outcome
Risk assessed to be some concerns for outcome: Mortality (D28).
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Blinded study (outcome assessor)
Risk assessed to be low for the outcomes: Mortality (D28)
|Selection of the reported results||
|Comment: The protocol and statistical analysis plan were not available. The prospective trial registry was available.
Mortality outcome was not pre-specified in the registry, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned.
Results were probably not selected from multiple outcome measurements or analyses of the data.
Trial analyzed as pre-specified.
Risk assessed to be low for the outcome: Mortality (D28).
|Overall risk of bias||