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.
No indication of cross-over. No information on administration of co-interventions of interest, anticoagulants and biologics. Antiviral and corticosteroid administration were reported. Data were analyzed according to intention-to-treat analysis. |
Missing outcome data |
Low |
Comment: 18 randomized, 18 analyzed.
Risk assessed to be low for outcomes: Incidence of clinical improvement. Serious adverse events |
Measurement of the outcome |
Some concerns |
Comment: Unblinded study.
Clinical improvement (defined as discharge from hospital) and serious adverse events reflect decisions made by the intervention provider and assessment could be influenced by knowledge of the intervention assignment but we did not consider this to have happened in the context of a pandemic. Risk assessed to be some concerns for the outcomes: Incidence of clinical improvement. Serious adverse events |
Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available.
Risk assessed to be some concerns for the outcome: Incidence of clinical improvement. Serious adverse events. |
Overall risk of bias |
Some concerns |