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: “block randomized (in blocks of 4) by computer-generated random numbering”
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “Patients and clinicians were not blinded to the treatment given.”
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, antivirals and biologics were reported and balanced between groups. Corticosteroid administration was also reported (0/20 CP vs 3/20 SC). This deviation was not balanced and could affect the outcome. Nevertheless, this domain was rated as some concern as it is impossible to distinguish deviation because of trial context and deviation because of intervention effect. 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 some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). |
| Missing outcome data |
Low |
Comment: 40 participants randomized; 40 participants analyzed.
Data available for all randomized participants. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor). MORTALITY, Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). (TIME TO) CLINICAL IMPROVEMENT Clinical improvement (defined as discharged alive) requires clinical judgement and could be affected by knowledge of intervention receipt but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcome: Clinical improvement (D28). |
| Selection of the reported results |
Some concerns |
Comment: The protocol (unclear date) and registry (retrospective; dated 22 April 2020) were available but no statistical analysis plan was available.
Mortality was specified in the protocol but with no timepoint, however it was registered (with timepoint) as reported in the paper. Result was not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). Clinical improvement (discharge) was neither registered nor specified in the protocol. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for outcome: Clinical improvement (D28). |
| Overall risk of bias |
Some concerns |