| 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. Baseline characteristics between intervention groups were comparable; any differences appear to be compatible with chance. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study. No indication of participant crossover. No information on co-interventions for glucocorticoids, antimalarials and biologics. 1 participant in the treatment arm progressed to critical severity (eligibility violation) and withdrew from the study. Outcome data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
30 randomized, 30 analyzed. Risk assessed to be low for outcomes: Mortality. Viral negative conversion. Time to viral negative conversion. Score 7 and above WHO. 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. Incidence of score 7 and above WHO (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. Score 7 and above WHO. 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 |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. Risk assessed to be some concerns for the outcomes: Mortality. Viral negative conversion. Time to viral negative conversion. Score 7 and above WHO. Serious adverse events. |
| Overall risk of bias |
High |