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: “Patients were randomized into groups … using the randomization envelope method.”
Comment: Allocation sequence random No information on allocation concealment |
Deviations from intervention |
Low |
Quote: Not available.
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. Information on administration of co-interventions of interest was reported and balanced: antivirals lopinavir/ritonavir were prescribed to 56 patients in the treatment group and 67 patients in the control group; corticosteroids (dexamethosone) was prescribed to 38 patients in the treatment group and 37 patients in the control group, 1 treatment patient received methylprednisolone. Biologics were the intervention. 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 outcomes: Adverse events. Serious adverse events. |
Missing outcome data |
Low |
Comment: 140 participants randomized; 140 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Adverse events. Serious adverse events. |
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). ADVERSE and SERIOUS ADVERSE EVENTS The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events, which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcomes: Adverse events. Serious adverse events. |
Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan and registry were not available
No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Adverse events. Serious adverse events. |
Overall risk of bias |
Some concerns |