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: "Patients were electronically randomized (using online application giving random numbers) into two groups" (report)
"Electronic (SPSS program) generated allocation sequence." (contact with authors) Comment: Allocation sequence random. Allocation probably concealed. |
| Deviations from intervention |
Some concerns |
Quote: "No blinding" (contact with authors)
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: biologics, antivirals (other than in the intervention). Hence, no information on whether deviations arose because of the trial context. MORTALITY, CLINICAL IMPROVEMENT, ADVERSE EVENTS 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 some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). Adverse events. INCIDENCE OF VIRAL NEGATIVE CONVERSION Participants were analyzed according to their randomized groups for the outcome. Of note, 72 vs 53 participants were excluded from the analysis post-randomization due to unknown reasons likely due to missing data which is accounted for in domain 3. Risk assessed to be some concerns for the outcome: Incidence of viral negative conversion (D7) |
| Missing outcome data |
Some concerns |
MORTALITY, CLINICAL IMPROVEMENT, ADVERSE EVENTS
Comment: 174 participants randomized; 174 participants analyzed. Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical Improvement (D28). Adverse Events. VIRAL NEGATIVE CONVERSION Comment: 174 participants randomized; 49 participants analyzed. Data not available for all or nearly all participants randomized. Reasons: unknown Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome (similar proportion of missingness between arms) Risk assessed to be some concerns for the outcome: Incidence of viral negative conversion (D7). |
| 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 (D7). Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). CLINICAL IMPROVEMENT Clinical improvement (defined as improvement in WHO ordinal scale) 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 outcome: Clinical improvement (D28).4 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. |
| 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: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28). Adverse events. |
| Overall risk of bias |
Some concerns |