Safety and Efficacy of Interferon β-1b in the Treatment of Severe COVID-19 Patients: An Open-Label Randomized Controlled Trial

Background: About a year after the start of the coronavirus disease 2019 (COVID-19) pandemic, the results of the studies conducted to investigate the effectiveness of interferon (INF) compounds in this disease were contradictory. Objectives: This study was carried out to examine the safety and efficacy of a treatment protocol containing INF-β-1b, hydroxychloroquine, and Kaletra (lopinavir/ritonavir) in patients with severe COVID-19. Methods: In this open-label, randomized controlled trial, severe cases of COVID-19 were included. Patients were eligible if they had epidemiological and radiological evidence compatible with COVID-19 or a positive polymerase chain reaction result and their disease was severe. They were randomly allocated into a control group that received the standard regimen (hydroxychloroquine and Kaletra) and an intervention group that received INF-β-1b treatment and the standard treatment regimen. Then, the two groups were compared in terms of in-hospital mortality, intubation, length of hospital stay, oxygen saturation, and lactate dehydrogenase before and after the intervention. Results: A total of 91 cases of severe COVID-19 were enrolled for analysis [intervention (n = 47) and control (n = 44)]. The length of hospital stay in the intervention group was significantly longer than in the control group (13.21 ± 6.88 vs. 10.52 ± 5.77 days; P = 0.047). The mortality rate did not significantly differ between the intervention and control groups (19.15% and 13.64%, respectively; P = 0.509). The intubation rate did not significantly differ between the intervention and control groups (12.76% and 11.36%, respectively; P = 0.838). Conclusions: The use of INF-β-1b-containing treatment regimens does not reduce mortality and intubation rates among patients with severe COVID-19. Furthermore, it might even increase the severity of the disease and the length of hospital stay for some patients; therefore, it is not recommended to use INF-β-1b in severe cases of COVID-19.