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 |
Report: “randomized (1:1) via balanced block randomization into treatment and non-treatment (standard) groups [39 persons per each group] by epidemiologists of the study”
Registry: "Simple randomization will be generated with a computer from 1 to 60. The computer will divide the digits between the two groups." Comment: Allocation sequence random. No information on allocation concealment. |
Deviations from intervention |
Some concerns |
Quote: “Clinicians and patients were not blind to treatment assignment.”
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: antivirals, corticosteroids, biologics and anticoagulants. Data were analyzed using intention-to-treat analysis |
Missing outcome data |
Low |
Comment: 78 patients randomized; 78 patients analyzed.
Data available for all participants. Risk assessed to be low for the outcomes: Mortality. Adverse events. |
Measurement of the outcome |
Some concerns |
Comment: Unblinded study (outcome assessor)
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality. Adverse events can both clinically- and laboratory-detected events and 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 outcome: Adverse events. |
Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The prospective registry was available.
Mortality was not specified as an outcome in the registry but was listed as a condition at discharge, with the time point of 'end of hospitalization'. In the report, 28-day mortality was a primary outcome. Analysis intentions were reported in sufficient detail to enable an assessment as 28 days was the maximum follow-up time and end of hospitalization would have been assessed during that time. Hence, mortality was measured in a similar way. Adverse events were not specified in the registry nor listed as a primary or secondary outcome in the report. Trial analyzed as prespecified. Result was probably not selected from multiple outcome measurements or analyses of the data. Risk assessed to be low for the outcomes: Mortality. Adverse events. |
Overall risk of bias |
Some concerns |