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 |
Some concerns |
Quote: "Two study groups set in a randomized manner by using the ABAB block was used for the patients." (report) "preparation of blocks and the placement of patients in blocks (assignment of patients to treatment groups) will be done by a third party who is not directly involved in the treatment of patients. Medications will also be prescribed by the clinical staff (assistants of the relevant departments) who are not involved in conducting this study" (registry)
Comment: Allocation sequence probably random. Unclear allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: "Single blinded" "Medications will also be prescribed by the clinical staff (assistants of the relevant departments) who are not involved in conducting this study. And trying to be a double-blind experiment." (registry)
Comment: Unclear blinding (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. Co-intervention of interest: Antivirals were the intervention and were administered to all participants. There was no information on administration on other co-interventions of interest: biologics and corticosteroids. Hence, no information on whether deviations arose because of the trial context. Our analysis for the outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcome: Mortality (D28). Time to clinical improvement. |
| Missing outcome data |
High |
Comment: 120 participants randomized; 112 participants analyzed.
Data not available for all or nearly all participants randomized; 7% missing data. No evidence that the result is not biased. Reasons: n=5 with no complete data, n=3 with loss to follow-up. Missingness could depend on the true value of the outcome. No information whether missingness depended on the true value of the outcome; reasons and proportions of missing data were not reported per group. Risk assessed to be high for the outcomes: Mortality (D28). Time to clinical improvement. |
| 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. Unclear blinding (outcome assessor). MORTALITY Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). TIME TO CLINICAL IMPROVEMENT Clinical improvement (defined as discharge) requires clinical judgement and could be affected by knowledge of intervention receipt, but it not considered likely to in the context of a pandemic. Risk assessed to be some concerns for the outcome: Time to clinical improvement. |
| Selection of the reported results |
Some concerns |
Comment: The retrospective trial registry was available.
No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Mortality (D28). Time to clinical improvement. |
| Overall risk of bias |
High |