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Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19.
Cao, Bin; Wang, Yeming; Lu, Hongzhou; Huang, Chaolin; Yang, Yumei; Shang, Lianhan; Chen, Zhu; Jiang, Rongmeng; Liu, Yihe; Lin, Ling; Peng, Ping; Wang, Fuxiang; Gong, Fengyun; Hu, Honglin; Cheng, Cong; Yao, Xiangyang; Ye, Xianwei; Zhou, Hourong; Shen, Yinzhong; Liu, Chenfan; Wang, Chunying; Yi, Zhennan; Hu, Bijie; Xu, Jiuyang; Gu, Xiaoying; Shen, Jingshan; Xu, Yechun; Zhang, Leike; Fan, Jia; Tang, Renhong; Wang, Chen.
Afiliación
  • Cao B; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Wang Y; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Lu H; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Huang C; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Yang Y; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Shang L; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Chen Z; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Jiang R; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Liu Y; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Lin L; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Peng P; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Wang F; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Gong F; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Hu H; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Cheng C; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Yao X; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Ye X; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Zhou H; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Shen Y; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Liu C; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Wang C; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Yi Z; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Hu B; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Xu J; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Gu X; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Shen J; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Xu Y; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Zhang L; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Fan J; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Tang R; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
  • Wang C; From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center
N Engl J Med ; 390(3): 230-241, 2024 Jan 18.
Article en En | MEDLINE | ID: mdl-38231624
ABSTRACT

BACKGROUND:

Simnotrelvir is an oral 3-chymotrypsin-like protease inhibitor that has been found to have in vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential efficacy in a phase 1B trial.

METHODS:

In this phase 2-3, double-blind, randomized, placebo-controlled trial, we assigned patients who had mild-to-moderate coronavirus disease 2019 (Covid-19) and onset of symptoms within the past 3 days in a 11 ratio to receive 750 mg of simnotrelvir plus 100 mg of ritonavir or placebo twice daily for 5 days. The primary efficacy end point was the time to sustained resolution of symptoms, defined as the absence of 11 Covid-19-related symptoms for 2 consecutive days. Safety and changes in viral load were also assessed.

RESULTS:

A total of 1208 patients were enrolled at 35 sites in China; 603 were assigned to receive simnotrelvir and 605 to receive placebo. Among patients in the modified intention-to-treat population who received the first dose of trial drug or placebo within 72 hours after symptom onset, the time to sustained resolution of Covid-19 symptoms was significantly shorter in the simnotrelvir group than in the placebo group (180.1 hours [95% confidence interval {CI}, 162.1 to 201.6] vs. 216.0 hours [95% CI, 203.4 to 228.1]; median difference, -35.8 hours [95% CI, -60.1 to -12.4]; P = 0.006 by Peto-Prentice test). On day 5, the decrease in viral load from baseline was greater in the simnotrelvir group than in the placebo group (mean difference [±SE], -1.51±0.14 log10 copies per milliliter; 95% CI, -1.79 to -1.24). The incidence of adverse events during treatment was higher in the simnotrelvir group than in the placebo group (29.0% vs. 21.6%). Most adverse events were mild or moderate.

CONCLUSIONS:

Early administration of simnotrelvir plus ritonavir shortened the time to the resolution of symptoms among adult patients with Covid-19, without evident safety concerns. (Funded by Jiangsu Simcere Pharmaceutical; ClinicalTrials.gov number, NCT05506176.).
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Inhibidores de Proteasa de Coronavirus / COVID-19 Tipo de estudio: Clinical_trials Límite: Adult / Humans País/Región como asunto: Asia Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Inhibidores de Proteasa de Coronavirus / COVID-19 Tipo de estudio: Clinical_trials Límite: Adult / Humans País/Región como asunto: Asia Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article