Objectives: To the best of our knowledge, there is no published study regarding use of IFN β-1a in the treatment of severe COVID-19. In this randomized clinical trial efficacy and safety of IFN β-1a has been evaluated in patients with severe COVID-19. Methods: Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir/ritonavir or atazanavir/ritonavir). Each 44 micrograms/ml (12 million IU/ml) of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted 39 patients that received only the national protocol medications. Primary outcome of study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of ICU stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects and complications during the hospitalization. Results: Between 29th February to 3rd April 2020, 92 patients were recruited that finally 42 patients in the IFN group and 39 patients in the control group completed the study. As primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 vs. 8.3 ± 4.9 days respectively, P=0.95). On day 14, 66.7% vs. 43.6% of patients in the IFN group and the control group were discharged, respectively (OR= 2.5; 95% CI: 1.05- 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% vs. 43.6% respectively, p= 0.015). Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118). Conclusion: Although IFN did not change time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality.

Highlights As Add-on therapy, IFN β-1b shortened the time to clinical improvement. IFN β-1b significantly increased the discharge rate at day 14. IFN β-1b reduced overall 28-day mortality. IFN β-1b related adverse effects were mild and did not cause treatment interruptions.

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