| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote:"This open-label, randomized clinical trial was designed to evaluate
the efficacy and safety of IFN β-1b in the treatment of patients with CoVID-19" "Patients were randomly recruited (1:1) to the IFN group or the control group. The method of randomization was the permuted block randomization (6 patients per block) "A biostatistician who was not involved in patients’ care did this process" |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No participant cross-over. No information on co-interventions of interest, biologics and anticoagulants. Administration of antivirals and glucocorticoids were reported. Appropriate analysis was used; participants analyzed according to their assigned intervention. |
| Missing outcome data |
Low |
Quote: "A total of 97 patients were screened. Of them, 15 patients did not
have the eligibility criteria of study and 2 patients were referred from
another hospital. Three and four patients withdrew the consent during the study in the IFN group and control groups, respectively. Four patients did not adhere to IFN injection after second or third dose. Also three patients in the control group were enrolled in another trial. Finally, 33 patients in each group completed the study" Comment: 80 eligible patients randomized, 66 analyzed. Missingness due to withdrawal of consent and dosage amounts (eligibility criteria) were unrelated to the outcome. Missingness due to transfer to another trial could have been due to the true value as theis only occurred in the control group. However, this accounted for <5% of missing data. Risk assessed to be low for outcomes: Mortality. Time to clinical improvement. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study.
Mortality is an observer-reported outcome not involving judgement. For the incidence of WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcome: Mortality. Incidence of WHO score 7 and above. Clinical improvement (defined as at least 2 points improvement on a 6-category scale) and incidence of WHO score 6 and above requires clinical judgment and could be affected by knowledge of intervention receipt. The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected outcomes. This 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 outcomes: Time to clinical improvement. Incidence of WHO score 6 and above. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available, though the authors stated they will include them as supplementary material. Outcomes poorly described in trial registry Risk assessed to be some concerns for outcomes: Mortality. Time to clinical improvement. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |