A Randomized Phase 2/3 Study of Ensitrelvir, a Novel Oral SARS-CoV-2 3C-Like Protease Inhibitor, in Japanese Patients with Mild-to-Moderate COVID-19 or Asymptomatic SARS-CoV-2 Infection: Results of the Phase 2a Part
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- Hiroshi Mukae
- Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
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- Hiroshi Yotsuyanagi
- The Institute of Medical Science, The University of Tokyo, Tokyo, Japan
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- Norio Ohmagari
- Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan
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- Yohei Doi
- Division of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA
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- Takumi Imamura
- Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Osaka, Japan
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- Takuhiro Sonoyama
- Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Osaka, Japan
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- Takahiro Fukuhara
- Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Osaka, Japan
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- Genki Ichihashi
- Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Osaka, Japan
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- Takao Sanaki
- Pharmaceutical Research Division, Shionogi & Co., Ltd., Toyonaka, Japan
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- Keiko Baba
- Pharmaceutical Research Division, Shionogi & Co., Ltd., Toyonaka, Japan
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- Yosuke Takeda
- Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Osaka, Japan
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- Yuko Tsuge
- Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Osaka, Japan
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- Takeki Uehara
- Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Osaka, Japan
抄録
<jats:p>This multicenter, double-blind, phase 2a part of a phase 2/3 study assessed the efficacy and safety of ensitrelvir, a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like protease inhibitor, in Japanese patients with mild-to-moderate coronavirus disease 2019 (COVID-19) or asymptomatic SARS-CoV-2 infection. Sixty-nine patients were randomized (1:1:1) to orally receive 5-day ensitrelvir fumaric acid (375 mg on day 1 followed by 125 mg daily, or 750 mg on day 1 followed by 250 mg daily) or placebo and followed up until day 28.</jats:p>
収録刊行物
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- Antimicrobial Agents and Chemotherapy
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Antimicrobial Agents and Chemotherapy 66 (10), 2022-10-18
American Society for Microbiology