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 study aimed to enroll 30 participants, with a 1:1 randomization ratio (N = 15 subjects in each arm)." Quote: "After informed consent, participants were randomized to the DRV/c group or the control group depending on the parity of their medical record number." Comment: Allocation sequence was not appropriately concealed. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. No information on administration of co-intervention of interest: corticosteroids, biologics. Antivirals were reported. Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 30 randomized, 30 analyzed.
Risk assessed to be low for outcomes: Mortality. Viral negative conversion. Time to viral negative conversion. WHO score 7 and above. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Mortality, Viral negative conversion and Time to viral negative conversion are observer-reported outcomes not involving judgement. WHO score 7 and above (intubation or death) is an outcome that reflects decisions made by the intervention provider. We consider that the assessment of these outcomes cannot possibly be influenced by knowledge of the intervention assignment. Risk assessed to be low for outcomes: Mortality. Viral negative conversion. Time to viral negative conversion. WHO score 7 and above. Serious adverse events may contain both clinically- and laboratory-detected outcomes, therefore it can be influenced by knowledge of the intervention assignment, but is not likely to. Risk assessed to be some concerns for outcomes: Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were not available. The registry was available.
All outcomes were listed in the registry and reported as such in the paper. Result was not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Time to viral negative conversion. WHO score 7 and above. Serious adverse events. |
| Overall risk of bias |
High |