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: “The randomization sequence was generated using Statistics and Sample Size application version 1.0. A simple randomization list was produced for a sample size of 80 and the participants were placed in to 2 groups of case and control with numeric sequential unique identifiers (simple or unrestricted randomization).”
Comment: Allocation sequence random. Unclear allocation concealment. |
Deviations from intervention |
Some concerns |
Quote: "This study was a partial double-blind study. During the treatment phase, the investigators could ascertain the patients' study-drug assignment (only in the event of an emergency) ... patients and health care professionals who were undertaking the outcome assessment of the primary outcome were blinded to the group to which the subject was assigned"
Comment: Unclear blinding (participants blinded and unclear if personnel remained blinded) Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: antivirals, biologics, and corticosteroids. 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: Mortality (D28). Clinical improvement (D28). |
Missing outcome data |
Low |
Comment: 80 participants randomized; 80 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). |
Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). |
Selection of the reported results |
Some concerns |
Comment: The trial registry was retrospective (dated 6 August 2020).
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 outcome: Clinical improvement (D28). We do not consider the reporting of mortality to be selective since mortality should be reported even if not planned. Results for mortality were probably not selected from multiple outcome measurements or analyses of the data. Risk assessed to be low for the outcome: Mortality (D28). |
Overall risk of bias |
Some concerns |