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-Reference-Cited by-同舟云学术

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

Published:2022-10-18 Issue:10 Volume:66 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Mukae Hiroshi¹,Yotsuyanagi Hiroshi²,Ohmagari Norio³,Doi Yohei⁴⁵,Imamura Takumi⁶,Sonoyama Takuhiro⁶,Fukuhara Takahiro⁶,Ichihashi Genki⁶,Sanaki Takao⁷,Baba Keiko⁷,Takeda Yosuke⁶,Tsuge Yuko⁶,Uehara Takeki⁶^ORCID

Affiliation:

1. Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

2. The Institute of Medical Science, The University of Tokyo, Tokyo, Japan

3. Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan

4. Division of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA

5. Departments of Microbiology and Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Japan

6. Drug Development and Regulatory Science Division, Shionogi & Co., Ltd., Osaka, Japan

7. Pharmaceutical Research Division, Shionogi & Co., Ltd., Toyonaka, Japan

Abstract

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.

Funder

Shionogi

Ministry of Health, Labour and Welfare

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/aac.00697-22

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