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 |
High |
Quote: “Patients were allocated randomly to the groups by computer generated number.”
"there was randomization but non-blinded and there was no concealment" Comment: Allocation sequence random. Allocation not concealed. |
| Deviations from intervention |
Low |
Quote: “Open-label”
Comment: Unblinded study. Deviations from intended intervention arising because of the study context: No participant cross-over. Administration of co-interventions of interest was reported and balanced between arms. Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for outcomes: Incidence of viral negative conversion (D7). Clinical improvement (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 50 patients randomized; 50 patients analyzed.
Data available for all or nearly all participants. Risk assessed as low for the outcome: Incidence of viral negative conversion (D7). Clinical improvement (D28). 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) Viral negative conversion is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Incidence of viral negative conversion (D7). Clinical improvement (defined as becoming asymptomatic), require clinical judgement and could be affected by knowledge of intervention receipt. Also, adverse events and serious adverse events may contain both clinically- and laboratory-detected events. All these outcomes 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: Clinical improvement (D28). Adverse events. Serious adverse events |
| Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan and registry were available.
Results for viral negative conversion, adverse events and serious adverse events were obtained via contact with authors. Results were not selected from multiple outcome measurements or analyses of the data. Trial probably analyzed as pre-specified. Risk assessed to be low for outcomes: Incidence of viral negative conversion (D7). Adverse events. Serious adverse events. Outcomes were not reported in the protocol and the registry was retrospective. 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 outcomes: Clinical improvement (D28). |
| Overall risk of bias |
High |