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 (acquired from contact with authors): "Site specific randomization schedule was generated by the biostatistician using SASĀ® Version 9.4 (SAS Institute Inc., USA) before the commencement of the study. Block randomization of size two in ratio of 1:1 was generated and balanced treatment allocation within block was ensured at the time of randomization generation. A unique patient number was provided to the randomized patients."
Comment: Allocation sequence random. Allocation sequence concealed. |
Deviations from intervention |
Low |
Quote: "Open-label"
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 acquired after contact with authors: antivirals, corticosteroids, antibiotics and biologics were balanced between the groups. 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: Mortality (D28). Clinical improvement (D28). Incidence of viral negative conversion (D7). Adverse events. Serious adverse events. |
Missing outcome data |
Low |
Comment: 60 participants randomized; 59 participants analyzed for all outcomes except clinical improvement (n=60)
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). Incidence of viral negative conversion (D7). 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, VIRAL NEGATIVE CONVERSION Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion. CLINICAL IMPROVEMENT Clinical improvement 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). ADVERSE and SERIOUS ADVERSE EVENTS The authors reported on adverse events and serious adverse events that 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 supplemental material and registry (dated Sept 18, 2020) were available.
MORTALITY. ADVERSE AND SEVERE ADVERSE EVENTS Outcomes pre-specified. Results were 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). Adverse events. Serious adverse events. VIRAL NEGATIVE CONVERSION Outcome not pre-specified. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Incidence of viral negative conversion (D7). CLINICAL IMPROVEMENT Outcome data acquired from contact with authors. 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 outcome: Clinical improvement (D28). |
Overall risk of bias |
Some concerns |