| 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 |
Some concerns |
Comment: The statistical analysis plan was not available. The protocol, available in Portuguese and dated 28.04.2020, and the registry, dated 04.05.2020, specifies the outcome of 28-day mortality but this was probably not before unblinded data were available for analysis, given that the start of enrollment was April 2020. Result was not selected from multiple outcome measurements nor multiple analyses of the data. Trial was probably not analyzed in accordance with a finalized, pre-specified plan. Risk assessed to be some concerns for the outcomes: Mortality. |
| Overall risk of bias |
Some concerns |