| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: “Participants were randomly assigned via a web-based secure centralized system (REDCap). An independent statistician provided a computer-generated assignment randomization list and blocked with varying block sizes unknown to the investigators”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: “open-label”
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: antivirals and corticosteroids, biologics. Data were analyzed appropriately; participants analyzed in the group to which they were randomly assigned |
| Missing outcome data |
Low |
Comment: 10 patients randomized; 10 patients analyzed.
Data available for all participants. Risk assessed to be low for the outcome: Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Quote: "open label"
Comment: Unblinded study Serious adverse events may contain both clinically- and laboratory-detected outcomes which 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: Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available.
Safety outcomes were not pre-specified in the registry. 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 outcome: Serious adverse events. |
| Overall risk of bias |
Some concerns |