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

 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.

 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.

 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.

 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).

 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.