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: "patients underwent randomization in the hospital".
Comment: No information on allocation sequence generation. No information on allocation concealment. Allocation sequence probably random. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. No information on administration of co-interventions of interest: biologics, corticosteroids. Antivirals were reported. Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 20 patients randomized; 20 patients analyzed.
Risk assessed to be low for the outcome: Serious adverse events. Risk assessed to be some concerns for the outcomes: Clinical improvement |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
For serious adverse events and clinical improvement, the intensity of adverse events (mild, moderate or severe) involves judgement which can 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: Clinicalimprovement. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The prospective registry was available and the trail was analyzed as pre-specified.
Result was not selected from multiple outcome measurements or analyses. Risk assessed to be low for the outcome: Clinical improvement. Serious adverse events. |
| Overall risk of bias |
Some concerns |