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 patients were randomised based on the Interactive Web Response System. All patients were divided into the treatment group (BRH group) or the control group (Control group) at a 2:1 ratio." Comment: Allocation sequence random. Allocation sequence was concealed. |
Deviations from intervention |
Some concerns |
Quote: "The study was an open-label randomized controlled pilot study, the open label nature is a limitation since the CT images was read blindly while the other endpoints could be affected by caregiver’s decision of drug allocation such as the use of oxygen therapy."
Comment: Unblinded study (participants and personnel/carers).
Deviations from intended intervention arising because of the study context: No indication of cross-over. No information on administration of co-intervention of interest, biologics. Antiviral and corticosteroid administration were reported. Hence, no information on whether deviations arose 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 some concerns for the outcomes: Clinical improvement (D28). Serious adverse events. |
Missing outcome data |
Low |
Comment: 18 participants randomized, 18 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for outcomes: Clinical improvement (D28). 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) Clinical improvement (defined as discharge from hospital) requires clinical judgement and could be affected by knowledge of intervention receipt. Also, the authors reported on serious adverse events that may contain both clinically- and laboratory-detected events. All these outcomes 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: Clinical improvement (D28). Serious adverse events |
Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available. The prospective versions of the registry were consulted but the outcomes were not pre-specified.
No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Clinical improvement (D28). Serious adverse events. |
Overall risk of bias |
Some concerns |