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: "Strict randomization processes were adhered to at each of the study’s medical centres, and a central randomization list created prior to enrolment. After enrolment, all sites received their patients’ randomization numbers by phone or Email."
Comment: Allocation sequence random Allocation sequence concealed |
| Deviations from intervention |
Some concerns |
Quote: “Open-labelled"
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: corticosteroids or biologics were reported. Antivirals were the intervention. MORTALITY. SERIOUS ADVERSE EVENTS. Our analysis for the binary outcomes are an 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. TIME TO VIRAL NEGATIVE CONVERSION. Participants were analyzed according to their randomized groups for the outcome. Of note, 2 vs 1 participants were excluded from the analysis post-randomization because they were lost to follow up. This will be accounted for in domain 3. Risk assessed to be some concerns for the outcome: Time to viral negative conversion. |
| Missing outcome data |
Low |
Comment: 96 participants randomized; 93 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to viral negative conversion. 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. TIME TO VIRAL NEGATIVE CONVERSION. Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Time to viral negative conversion. 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: Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The prospective registry was available (dated 14 May 2020).
MORTALITY. TIME TO VIRAL NEGATIVE CONVERSION. Outcome pre-specified. 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 outcome: Mortality (D28). Time to viral negative conversion. SERIOUS ADVERSE EVENTS Outcome not pre-specified. 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 |