Efficacy and Safety of Favipiravir in Moderate COVID-19 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
Infectious Diseases and Therapy, doi:10.1007/s40121-021-00517-4
Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 , is an enveloped, single-stranded RNA virus. Favipi-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 Supplementary Information The online version contains supplementary material available at https://
Authorship. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Authorship Contributions. Conceptualization: Satoshi Iwata, Tsutomu Sakurai; Methodology: Satoshi Iwata, Osamu Kobayashi, Hiroyuki Kunishima, Masaharu Shinkai; Formal analysis: Yoshihiko Matsumoto, Tsutomu Sakurai; Investigation: 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 and Takashi Ogura; Supervision: Satoshi Iwata; Writing -original draft preparation; Masaharu Shinkai. All authors commented on previous versions of the manuscript. All authors read and approved the submitted version. Disclosures. Tsutomu Sakurai and Yoshihiko Matsumoto are employees of the sponsor. 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..
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