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: "All eligible patients were randomly assigned to a random number
allocated from a random number sequence generated by a
computer, which excluded potential influence from treating physicians, to one of three treatment groups: RBV+IFN-a, LPV/ r+IFN-a, and RBV+LPV/r+IFN-a, with an allocation ratio of 1:1:1, and a block size of nine patients each."
Following contact with authors: "The randomization sequence was triggered by the investigator entering all participant concealed until interventions were assigned, after which participants and investigators were not masked to treatment. Laboratory staff performing quantitative or qualitative testing were blinded to treatment allocation, while medical staff were not blinded". Comment: Allocation sequence was generated randomly and concealed. |
Deviations from intervention |
Low |
Comment: Unblinded study (participants and personnel/carers).
Deviations from intended intervention arising because of the study context: No patient cross-over. Administration of co-interventions of interest, antivirals, biologics and corticosteroids were reported. Co-interventions were balanced across 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). Time to Viral Negative Conversion. WHO score 7 and above (D28). Adverse events. Serious adverse events. |
Missing outcome data |
Low |
Comment: 101 participants randomized; 101 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Time to Viral Negative Conversion. 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, (TIME TO) VIRAL NEGATIVE CONVERSION Mortality and viral negative conversion are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Time to viral negative conversion. WHO SCORE 7 AND ABOVE 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: WHO score 7 and above (D28). ADVERSE and SERIOUS ADVERSE EVENTS The authors reported on adverse events and serious 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 outcomes: Adverse events. Serious adverse events |
Selection of the reported results |
Low |
Comment: Protocol and statistical plan and registry were available.
TIME TO VIRAL NEGATIVE CONVERISION, AE, SAE Outcome pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Time to viral negative conversion. Adverse events. Serious adverse events. MORTALITY, VIRAL NEGATIVE CONVERSION, WHO SCORE 7 AND ABOVE Outcome data acquired from contact with authors. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). |
Overall risk of bias |
Some concerns |