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 |
Low |
Quote: "Randomisation was computer generated" (report) "Randomisation will be performed using a web-based randomisation system (built in REDCap) hosted at the Edinburgh Clinical Trials Unit (ECTU) at the University of Edinburgh" (registry)
Comment: Allocation sequence random. Allocation sequence probably concealed. |
| Deviations from intervention |
Some concerns |
Quote: "open label"
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. Co-interventions of interest (antivirals, biologics, and corticosteroids) were listed among standard care medications, but it was not reported how many participants received these co-interventions. Hence, no information on whether deviations arose 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: Mortality (D28). Clinical improvement (D28). Clinical improvement (D60 or more). Adverse events. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 44 participants randomized; 42 participants analyzed.
Data not available for all participants randomized. No evidence that the result is not biased. Reasons: 2 vs 0 withdrawn before receiving intervention; 1 vs 0 patient lost to follow up. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome. Risk assessed to be some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). Clinical improvement (D60 or more). 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) MORTALITY Observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). CLINICAL IMPROVEMENT Clinical improvement (defined as discharge) requires clinical judgement and could be affected by knowledge of intervention receipt, but it not considered likely to in the context of a pandemic. Risk assessed to be some concerns for the outcomes: Clinical improvement (D28). Clinical improvement (D60 or more). ADVERSE AND SERIOUS ADVERSE EVENTS. The authors reported on 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 outcome: Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan, registry were available (dated 9 July 2020).
MORTALITY Mortality outcome was not pre-specified in the registry, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably 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). CLINICAL IMPROVEMENT. ADVERSE EVENTS. Outcomes were pre-specified in the registry. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Clinical improvement (D28). Clinical improvement (D60 or more). Adverse events. SERIOUS ADVERSE EVENTS Outcome not pre-specified in the registry. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Serious adverse events. |
| Overall risk of bias |
Some concerns |