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: “A serial number is assigned to each patient enrolled to randomly assign participants to one of the two groups using dedicated software”
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “This is an interventional, non-pharmacological, open, randomized, prospective, double arms. non-profit study.”
Comment: Unblinded study. No participant cross-over. Administration of co-interventions of interest reported: antivirals and biologics. Use of corticosteroids not reported. Appropriate method of analysis used; participants analyzed according to allocated intervention. |
| Missing outcome data |
Low |
Comment: 28 patients randomized; 28 patients analyzed.
Data available for all patients. Risk assessed to be low for the outcome: Mortality. |
| Measurement of the outcome |
Low |
Quote: “This is an interventional, non-pharmacological, open, randomized, prospective, double arms. non-profit study.”
Comment: Unblinded study. Mortality is an observer-reported outcomes not involving judgement. Risk assessed to be low for the outcome: Mortality. |
| Selection of the reported results |
High |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was available.
Mortality was mentioned in the registry as part of the outcome "Delta of crude mortality [ Time Frame: 21 days ]" but in the published article, the secondary outcome was "Detla of crude mortality (at day 7-14-30)." Results were probably selected on the basis of multiple outcome measurements (different timepoints) Trail was not analyzed as pre-specified. Risk assessed to be high for the outcome: Mortality. |
| Overall risk of bias |
High |