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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
http://hdl.handle.net/10069/00041856
http://hdl.handle.net/10069/00041856e2b6e4b3-dfac-46ba-bc9b-6ce34d54b053
名前 / ファイル | ライセンス | アクション |
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AAC66_e0069722.pdf (1.6 MB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2022-10-31 | |||||
タイトル | ||||||
タイトル | 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 | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | COVID-19 | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | ensitrelvir | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Japanese | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | proof-of-concept study | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | S-217622 | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | SARSCoV- 2 3C-like protease inhibitor | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | viral titer | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Mukae, Hiroshi
× Mukae, Hiroshi× Yotsuyanagi, Hiroshi× Ohmagari, Norio× Doi, Yohei× Imamura, Takumi× Sonoyama, Takuhiro× Fukuhara, Takahiro× Ichihashi, Genki× Sanaki, Takao× Baba, Keiko× Takeda, Yosuke× Tsuge, Yuko× Uehara, Takeki |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | 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 ARSCoV- 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. The primary outcome was the change from baseline in the SARS-CoV-2 viral titer. A total of 16, 14, and 17 patients in the ensitrelvir 125 mg, ensitrelvir 250 mg, and placebo groups, respectively, were included in the intention-to-treat population (mean age: 38.0 to 40.4 years). On day 4, the change from baseline in SARS-CoV-2 viral titer (log10 50% tissue culture infectious dose/mL) in patients with positive viral titer and viral RNA at baseline was greater with ensitrelvir 125 mg (mean [standard deviation], –2.42 [1.42]; P = 0.0712) and 250 mg (–2.81 [1.21]; P = 0.0083) versus placebo (–1.54 [0.74]); ensitrelvir treatment reduced SARS-CoV-2 RNA by –1.4 to –1.5 log10 copies/ mL versus placebo. The viral titer and viral RNA were similar across groups on and after day 6. The median time to infectious viral clearance decreased by approximately 50 h with ensitrelvir treatment. All adverse events were mild to moderate. Ensitrelvir treatment demonstrated rapid SARS-CoV-2 clearance and was well tolerated (Japan Registry of Clinical Trials identifier: jRCT2031210350). | |||||
書誌情報 |
Antimicrobial Agents and Chemotherapy 巻 66, 号 10, p. e0069722, 発行日 2022-09-13 |
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出版者 | ||||||
出版者 | American Society for Microbiology | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 0066-4804 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1128/aac.00697-22 | |||||
権利 | ||||||
権利情報 | ⓒ 2022 Mukae et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license. | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
引用 | ||||||
内容記述タイプ | Other | |||||
内容記述 | Antimicrobial Agents and Chemotherapy, 66(10), art. no. e0069722; 2022 |