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: "Patients were randomly assigned to either the triple combination lopinavir–ritonavir, ribavirin, and interferon beta-1b group or the control group (lopinavir–ritonavir only), in the ratio of 2:1, by simple randomisation with no stratification. Randomised treatment was open-label. Patients were assigned to a serial number by the study coordinator. Each serial number was linked to a computer-generated randomisation list assigning the antiviral treatment regimens. The study medications were dispensed by the hospital pharmacy and then to the patients by the medical ward nurses."
Allocation sequence random. Allocation sequence probably concealed. |
| Deviations from intervention |
Low |
Comment: Unblinded study. There is no evidence of deviation from the intended intervention that arose because of the trial context’ (i.e., no cross-over; co-interventions administered are balanced between arms). A higher proportion of participants in the treatment received glucocorticoids, compared to the control arm (69,7% vs 48,7%); however this difference is small in absolute values (i.e., number of participants that received glucocorticoids per arm: 6 vs 2). Outcome data were analyzed by using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 127 randomized/127 analyzed. Risk assessed to be low for the outcomes: Viral negative conversion incidence. Time to negative viral conversion. Mortality. WHO score 6 and above and WHO sore 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: the trial was not blinded. Outcomes are observer-measured and do not involve clinical decision-making except for WHO score 6, which involves clinician judgment, and adverse events which could be patient-reported or involve assessor judgment. Risk assessed to be "low" for the outcomes: Mortality. Viral negative conversion incidence. Time to viral negative conversion. WHO score 6 and above. Risk assessed to be "some concerns" for the outcomes: WHO score 7 and above. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: the protocol was available. The statistical analysis plan was not available. Risk assessed to be "low" for the outcomes: Mortality. Time to viral negative conversion. Viral negative conversion incidence. WHO score 6 and above and WHO sore 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |