The authors thank the patients for contributing to this work. The authors are also grateful to everyone who bravely treated the COVID-19 patients, to Taiichiro Kobayashi M.D. Ph.D. (Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan) who made a great contribution to patient recruitment, to Ms. Kiyomi Kabasawa (Tokyo Shinagawa Hospital, Tokyo, Japan), Ms. Kaoru Sato (I'rom EC Co., Ltd., Tokyo, Japan) who assisted with data entry, and to all other Clinical Research Coordinators involved in patient enrollment at the study centers. The authors are also grateful to the Central Committee members for their independent evaluation of the study: Yasuyuki Kato, M.D., M.P.H (International University of Health and Welfare, School of Medicine, Narita, Chiba), Hideki Araoka, M.D. (Toranomon Hospital, Tokyo, Japan), Ichiyo Obara, M.D. Ph.D. (Japan Self-Defense Forces Yokosuka Hospital, Kanagawa, Japan), Shigeki Misumi, M.D. Ph.D. (Jikei University School of Medicine, Tokyo, Japan), and Toshihito Furukawa (Biostatistical Research Co., Ltd., Tokyo, Japan).
Funding
This trial was sponsored by FUJIFILM Toyama Chemical Co., Ltd. The Rapid Service Fees were funded by the sponsor.
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 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, Hiroyuki Kunishima, Osamu Kobayashi and Satoshi Iwata have nothing to disclose. Sho Fujiwara is currently affiliated with Department of Emergency Medicine, Tokyo Hikifune Hospital, 2-27-1 Higashi-Mukojima, Sumida-ku, Tokyo 131-0032, Japan. Daiki Kanou is currently affiliated with Department of Respiratory Medicine, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-004, Japan.
Compliance with Ethics Guidelines
This trial plan was filed to Japanese regulatory authorities (IND #2019-7269). The protocol, informed consent form, and all other required documents were reviewed by an Institutional Review Board (IRB) of each trial site prior to initiation of the trial at that site. The trial was approved by all IRBs (please see supplementary material) and was conducted in accordance with the Helsinki Declaration (1964 and its later amendments) and Good Clinical Practice.
Data Availability
The datasets generated during and/or analyzed during the current study are currently being submitted to regulatory authorities due to NDA and are not publicly available. The datasets will be available from the sponsor on reasonable request after regulatory approval.