| 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 |