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|
|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.
Allocation sequence probably concealed.
|Deviations from intervention||
|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 was the intervention and was administered to all participants. There was no information on administration of co-interventions of interest: biologics and corticosteroids.
Hence, no information on whether deviations arose because of the trial context.
No information on whether data for the outcome were analyzed using intention-to-treat analysis (unclear number randomized). No information on whether the analysis was appropriate to estimate the effect of assignment to intervention.
There was probably no substantial impact of failure to analyze participants in their randomized groups.
Risk assessed to be some concerns for the outcome: Mortality (D28). Time to clinical improvement.
|Missing outcome data||
|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||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unclear blinding (outcome assessor).
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||
|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||