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 |
| Randomization |
Some concerns |
Quote: “blocked randomization, and the participants were randomized in a 1:1 ratio within two blocks of ten patients each. The patients were assigned to each treatment by drawing the sequential numbering of opaque envelopes containing the treatment allocation.”
Comment: Allocation sequence random. Unclear allocation concealment (No information on sealing of envelopes). |
| Deviations from intervention |
Low |
Quote: “open-label study”
Comment: Unblinded study participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. Administration of all co-interventions of interest: (antivirals, corticosteroids and biologics) were reported and balanced between groups. 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 low for the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 20 participants randomized; 20 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcome: Mortality (D28). |
| Measurement of the outcome |
Low |
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). |
| Selection of the reported results |
Some concerns |
Comment: The statistical analysis plan was not available. The protocol was available in Portuguese and the registry was available in English. Both were retrospective with no access to the prospective versions at the time of review.
No information on whether the result was selected from multiple outcome measurements nor multiple analyses of the data. No information on whether the trial was analyzed in accordance with a pre-specified plan. Risk assessed to be some concerns for the outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |