| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
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."
Comment: It is unclear if a central randomization was considered to ensure allocation concealment. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. Administration of all co-interventions of interest were reported: antivirals, biologics, anticoagulants, glucocorticoids. Imbalance in biologics and glucocorticoid administration (6.97% vs 4.87% in the intervention vs control arms in both); however this difference is small in absolute values (i.e. number of participants that received glucocorticoids per arm: 6 vs 2; the same applied to biologics). Outcome data were analyzed 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 |