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 |
High |
Quote: "A digitally derived random sequence divided into four
blocks of twenty was used for randomizing the patients. A computer-generated random sequence, communicated to the
trial site on the day of enrolment as each patient meeting the inclusion criteria were
identified. After randomization of the patients the allocations were not concealed."
Comment: Allocation sequence random. Allocation sequence not concealed. |
| Deviations from intervention |
Low |
Quote: “Open Label”
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: antvirals, corticosteroids and biologics were reported and were balanced between groups. Hence, deviations did not arise 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 low for the outcome: Mortality (D28). Time to death. |
| Missing outcome data |
Low |
Comment: 80 participants randomized; 80 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcome: Mortality (D28). Time to death. |
| 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). Time to death. |
| Selection of the reported results |
Some concerns |
Comment: The protocol and registry were available (dated 15/05/2020).
Mortality outcome was prespecified in the registry but the timepoint at 30 days was not prespecified. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). Time to death. |
| Overall risk of bias |
High |