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: “Unstratified randomization was done in a 1:1 ratio utilizing a block balance randomization method. The investigator (IAD) enrolled the patients and only then opened envelopes to assign patients to the different treatment groups. This method of randomization and allocation concealment results in minimum selection and confounding biases.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: “Open-label”
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. All patients received the intended treatment as scheduled. Antinvirals were included in both the treatment and control treatment No information on administration of co-interventions of interest: 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). Time to clinical improvement. |
| Missing outcome data |
Low |
Comment: 101 participants randomized; 101 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to clinical improvement. |
| 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) MORTALITY 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 an improvement of two points of the seven-category ordinal scale or discharge from the hospital, whichever comes first) 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 outcomes: Time to clinical improvement. |
| Selection of the reported results |
Low |
Comment: The registry was available. The trial appears to have been registered prospectively on April 14 2020, with an estimated start date of April 15.
Outcomes pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Time to clinical improvement. |
| Overall risk of bias |
Some concerns |