Abstract: International Journal of Infectious Diseases 102 (2021) 538–543 Contents lists available at ScienceDirect International Journal of Infectious Diseases journal homepage: www.elsevier.com/locate/ijid Randomized controlled open label trial on the use of favipiravir combined with inhaled interferon beta-1b in hospitalized patients with moderate to severe COVID-19 pneumonia Faryal Khamisa,* , Hanan Al Naabib , Adil Al Lawatib , Zaiyana Ambusaidib , Mariam Al Sharjic, Umkulthum Al Barwanid , Nenad Pandaka , Zakariya Al Balushia , Maher Al Bahranie , Issa Al Salmif , Ibrahim Al-Zakwanig a Infection Diseases Unit, Department of Medicine, Royal Hospital, Muscat, Oman Acute Medicine Unit, Department of Medicine, Royal Hospital, Muscat, Oman c Department of Nursing, Royal Hospital, Muscat, Oman d Department of Pharmacy, Royal Hospital, Muscat, Oman e Department of Anesthesia and Critical Care, Royal Hospital, Muscat, Oman f Department of Nephrology, Royal Hospital, Muscat, Oman g Department of Pharmacology & Clinical Pharmacy, College of Medicine & Clinical Pharmacy, Sultan Qaboos University, Muscat, Oman b A R T I C L E I N F O A B S T R A C T Article history: Received 21 September 2020 Received in revised form 3 November 2020 Accepted 4 November 2020 Objective: To evaluate the therapeutic effectiveness of favipiravir combined with inhaled interferon beta1b in adult patients hospitalized with moderate to severe COVID-19 pneumonia. Methods: A randomized, open-label controlled trial of oral favipiravir in adults hospitalized with moderate to severe COVID-19 pneumonia from June 22nd 2020 to August 13th 2020 was conducted. Patients were randomly assigned to receive either a combination of favipiravir with interferon beta-1b by inhalation aerosol or hydroxychloroquine (HCQ). The outcome endpoints included improvement in inflammatory markers, lower length of hospital stay (LOS), discharges and lower overall 14-day mortality. Results: A total of 89 patients underwent randomization with 49% (n = 44) assigned to favipiravir and 51% (n = 45) assigned HCQ. The overall mean age was 55
14 years and 58% (n = 52) were males. There were no significant differences in the inflammatory biomarkers at hospital discharge between the two groups; C-reactive protein (p = 0.413), ferritin (p = 0.968), lactate dehydrogenase (p = 0.259) and interleukin 6 (p = 0.410). There were also no significant differences between the two groups with regards to the overall LOS (7 vs 7 days; p = 0.948), transfers to the ICU (18.2% vs 17.8%; p = 0.960), discharges (65.9% vs 68.9%; p = 0.764) and overall mortality (11.4% vs 13.3%; p = 0.778). Conclusions: No differences in clinical outcomes were found between favipiravir plus inhaled interferon beta-1b and hydroxychloroquine in adults hospitalized with moderate to severe COVID-19 pneumonia. © 2020 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncnd/4.0/).