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: "Once patients passed the inclusion and exclusion criteria and signed the
consent form, they were randomly assigned to either the control arm or
the treatment arm in a 1:1 ratio using a computer-generated randomization
plan. Block randomization with a block size of 2 was used."
Comment: Allocation sequence random. No information on allocation concealment. |
Deviations from intervention |
Some concerns |
Quote: "Managing physicians and patients were not blinded."
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest reported: biologics. Antivirals (lopinavir/ritonavir) and corticosteroids were reported. Hence, no information on whether deviations arose because of the trial context. 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). Serious adverse events. |
Missing outcome data |
Low |
Comment: 70 participants randomized, 66 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reason: Randomized in error (met exclusion/inclusion criteria) [2 vs 2] occurred due to documented reasons unrelated to the outcome. Discontinued intervention [2 vs 0] but this missing data constitutes <5% of population. Risk assessed to be low for outcomes: Mortality (D28). Serious adverse events |
Measurement of the outcome |
Low |
Quote: "The investigator, outcome assessor and data analyser were masked."
Method of measuring the outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Serious adverse events |
Selection of the reported results |
Low |
Comment: No protocol or statistical analysis plan available. The registry was available and utilized.
Mortality and Serious adverse events were both registered with timepoints and reported as such in the paper. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Serious adverse events. |
Overall risk of bias |
Some concerns |