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: "The patients were randomized 1:1."
Quote from contact of authors: "Randomization were performed depending on the parity of the subjects’ medical records generated at administration. The treating physician were responsible for enrolling participants and assigned the participants to different groups." Comment: Allocation sequence random. Allocation sequence probably not concealed. |
| Deviations from intervention |
Low |
Quote: "single-center, prospective, randomized, and open-label study"
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, antivirals, biologics and corticosteroids, were reported and balanced between arms. Hence, deviations did not arise because of the trial context. 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 the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 30 participants randomized, 30 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). WHO score 7 and above (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). Mortality and viral negative conversion are observer-reported outcomes, not involving judgement. For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO Score 7 and above (D28). The authors reported on adverse events and serious adverse events that 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: Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was available and the February 6th, 2020 version (prospective) was consulted.
Viral clearance, mortality and adverse events were listed in the registry and reported in the paper appropriately. WHO score 7 and above outcome data acquired from contact with authors. Results were not taken from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of negative viral conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
High |