Abstract: Infect Dis Ther (2021) 10:2489–2509 https://doi.org/10.1007/s40121-021-00517-4 ORIGINAL RESEARCH Efficacy and Safety of Favipiravir in Moderate COVID19 Pneumonia Patients without Oxygen Therapy: A Randomized, Phase III Clinical Trial Masaharu Shinkai . Kenji Tsushima . Shingo Tanaka . Eri Hagiwara . Norihito Tarumoto . Ichiro Kawada . Yuji Hirai . Sho Fujiwara . Yuko Komase . Takeshi Saraya . Hidefumi Koh . Naho Kagiyama . Megumi Shimada . Daiki Kanou . Shinichi Antoku . Yujiro Uchida . Yutaka Tokue . Mikio Takamori . Yasuhiro Gon . Kenya Ie . Yoshitaka Yamazaki . Kazumasa Harada . Naoki Miyao . Takashi Naka . Mitsunaga Iwata . Atsushi Nakagawa . Kazutoshi Hiyama . Yoshihiko Ogawa . Masahiro Shinoda . Shinichiro Ota . Takatomo Hirouchi . Jiro Terada . Shuichi Kawano . Takashi Ogura . Tsutomu Sakurai . Yoshihiko Matsumoto . Hiroyuki Kunishima . Osamu Kobayashi . Satoshi Iwata Received: May 21, 2021 / Accepted: July 27, 2021 / Published online: August 27, 2021 Ó The Author(s) 2021 ABSTRACT Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), is an enveloped, single-stranded RNA virus. Favipi- Supplementary Information The online version contains supplementary material available at https:// doi.org/10.1007/s40121-021-00517-4. ravir is an orally administrable antiviral drug whose mechanism of action is to selectively inhibit RNA-dependent RNA polymerase. A preliminary trial in COVID-19 patients reported significant improvements across a multitude of clinical parameters, but these findings have not been confirmed in an adequate well-controlled trial. We conducted a randomized, single-blind, placebo-controlled Phase III trial assessing the efficacy and safety of favipiravir in patients with M. Shinkai
M. Shinoda
S. Ota
T. Hirouchi Department of Respiratory Medicine, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawaku, Tokyo 140-8522, Japan N. Tarumoto Department of Infectious Disease and Infection control, Saitama Medical University Hospital, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan K. Tsushima
J. Terada Department of Pulmonary Medicine, School of Medicine, International University of Health and Welfare, 852 Hatakeda, Narita, Chiba 286-8520, Japan I. Kawada Division of Pulmonary Medicine, Department of Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan S. Tanaka Department of Otolaryngology, Self-Defense Forces Central Hospital, 1-2-24 Ikejiri, Setagaya-ku, Tokyo 154-8532, Japan E. Hagiwara
T. Ogura Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama, Kanagawa 236-0051, Japan Y. Hirai Department of Infectious Diseases, Tokyo Medical University Hachioji Medical Center, 1163 Tatemachi, Hachioji, Tokyo 193-0998, Japan S. Fujiwara Department of Infectious Diseases, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan 2490 moderate pneumonia not requiring oxygen therapy. Methods: COVID-19 patients with moderate pneumonia (SpO2 C 94%) within 10 days of onset of fever (temperature C 37.5 °C) were assigned to receive either placebo or favipiravir (1800 mg twice a day on Day 1, followed by 800 mg twice a day for up to 13 days) in a ratio of 1:2. An adaptive design was used to re-estimate the sample size. The primary endpoint was a..