Abstract: International Journal of General Medicine Dovepress open access to scientific and medical research International Journal of General Medicine For personal use only. Open Access Full Text Article C L I N I C A L T R I A L R E P O RT Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting Pavan Kumar Reddy 1 , Saiprasad Patil 2 , Akash Khobragade 3 , Akash Balki 4 , Aneesh Raj 5 , Mrunalini Kalikar 6 , Raghavendra Reddy 7 , Ravindra Shinde 8 , Jayanthi CR 9 , Abhinandan Mutha 10 , Nagaraju Boyilla 11 , Girish C Rajadhyaksha 12 , Niteen Karnik 13 , Sagar Bhagat 2 , Amol Pendse 14 , Priyanka Dhage 15 , Wen Wu 16 , Shabbir Rangwala 14 , Hanmant Barkate 2 1 Critical Care Medicine, Care Hospital, Hyderabad, Telangana, India; 2Global Medical Affairs, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India; 3St. George’s Hospital, Mumbai, Maharashtra, India; 4Shree Hospital & Critical Care Center, Nagpur, Maharashtra, India; 5NIMS Medicity, Trivandrum, Kerala, India; 6Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India; 7Renova Neelima Hospitals, Hyderabad, Telangana, India; 8Respiratory Medicine, Dr Vasantrao Pawar Medical College, Nashik, Maharashtra, India; 9Bangalore Medical College, Bengaluru, Karnataka, India; 10Siddhi Hospital, Nasik, Maharashtra, India; 11Aster Prime Hospital, Hyderabad, Telangana, India; 12Department of Medicine, BYL Medical college & Nair Hospital, Mumbai, Maharashtra, India; 13Department of Medicine, LT Medical College & Sion Hospital, Mumbai, Maharashtra, India; 14Clinical Research Operations, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India; 15Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India; 16Glenmark Pharmaceuticals Ltd., Waterford, UK Correspondence: Sagar Bhagat, Tel +919930553638, Email Sagar.Bhagat@glenmarkpharma.com Purpose: To evaluate the safety and efficacy of favipiravir, which is prescribed for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) in India. Patients and Methods: This was a prospective, open-label, multicenter, single-arm postmarketing study conducted in India. Patients with mild-to-moderate COVID-19 received favipiravir (3600 mg [1800 mg orally twice daily] on the first day, followed by 800 mg orally twice daily, up to a maximum of 14 days) as a part of their treatment. The primary endpoints were to evaluate the safety of favipiravir by assessing the number of adverse events (AEs) and treatment-related AEs. The secondary endpoints were to evaluate the efficacy of favipiravir by assessing time to clinical cure, rate of clinical cure, time to pyrexia resolution, rate of oxygen requirement, and all-cause mortality. Results: A total of 1083 patients were enrolled in this study from December 2020 to June 2021. Adverse events were reported in 129 patients (11.9%), 116 (10.7%) of whom had mild AEs. Dose modification or withdrawal of favipiravir treatment was reported in four patients (0.37%). The median time to clinical cure and pyrexia resolution was 7 and 4 days, respectively. A total of 1036 patients (95.8%) exhibited clinical cure by day 14. Oxygen support was required by 15 patients (1.4%). One death was reported, which was unrelated to favipiravir. Conclusion: In the real-world setting, favipiravir was well-tolerated, and no new safety signals were detected. Keywords:..