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 patients.
No patient cross-over.
Administration of co-interventions of interest (antivirals, corticosteroids and anticoagulants) was reported. No information on biologics.
Appropriate analysis method used; patients analyzed according to assigned intervention.
Risk assessed to be some concern for the outcome: Mortality D28. Hospitalization or death
|Missing outcome data||
|Comment: 84 randomized; 84 analyzed.
Data available for all or nearly all participants randomized.
Risk assessed to be low for outcome: Mortality D28. Hospitalization or death
|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 outcomes not involving judgement.
Risk assessed to be low for the outcomes: Mortality (D28)
HOSPITALIZATION OR DEATH
Hospitalization or death, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment.
Risk assessed to be low for the outcome: Hospitalization or death.
|Selection of the reported results||
|Comment: The protocol and statistical analysis plan were not available. The trial registry does not list mortality as an outcome but it is mentioned as an indicator of disease progression (primary outcome).
Risk assessed to be low for the outcome: Mortality.
Outcome Hospitalization or death pre-specified.
Results were not selected from multiple outcome measurements or analyses of the data.
Trial analyzed as pre-specified.
Risk assessed to be low for the outcome: Hospitalization or death
|Overall risk of bias||