| 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. No information on allocation concealment (sealing of envelopes). |
| Deviations from intervention |
Low |
Quote: “open-label study”
Comment: Unblinded study. No participant cross-over. Administration of all co-interventions of interest: (antivirals, corticosteroids and biologics) were reported and balanced between groups. Appropriate analysis method used; participants analyzed according to intervention assignment. |
| Missing outcome data |
Low |
Comment: 20 patients randomized; 20 patients analyzed.
Data available for all patients. Risk assessed to be low for the outcome: Mortality. |
| Measurement of the outcome |
Low |
Comment: Unblinded study
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality. |
| Selection of the reported results |
Low |
Comment: The statistical analysis plan was not available. The protocol was available in Portuguese and the registry was available in English.
28-day mortality was a registered outcome and reported as such in the paper. Result was not selected from multiple outcome measurements nor multiple analyses of the data. Trial was analyzed in accordance with a pre-specified plan. Risk assessed to be low for the outcome: Mortality. |
| Overall risk of bias |
Some concerns |