口服simnotrelvir适用于轻度至中度Covid-19的成年患者
Bin Cao1, Yeming Wang1, Hongzhou Lu1
1From 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 for Respiratory Medicine, China-Japan Friendship Hospital, Changping Laboratory (B.C., Chen Wang), the Department of Medicine, Non-oncology, Jiangsu Simcere Pharmaceutical (Y.Y.), Clinical and Research Center of Infectious Diseases Beijing Ditan Hospital, Capital Medical University (R.J.), and Chinese Academy of Medical Sciences and Peking Union Medical College (Chen Wang), Beijing, the Department of Infectious Diseases, Third People's Hospital of Shenzhen, National Clinical Research Center for Infectious Diseases, Shenzhen (H.L., F.W.), Jin Yin-tan Hospital (C.H., F.G.) and Wuhan Institute of Virology, Chinese Academy of Sciences (L.Z.), Wuhan, the Public Health Clinical Center of Chengdu, Chengdu (Z.C.), Tianjin First Central Hospital, Tianjin (Y.L.), the Department of Cardiology, Hainan Third People's Hospital, Sanya (L.L.), the Department of Respiratory Medicine, Guangzhou Eighth People's Hospital, Guangzhou (P.P.), the Department of Clinical Statistics and Data Management, Jiangsu Simcere Pharmaceutical (H.H.), the Department of Infection and Immunity, Shanghai Public Health Clinical Center (Y.S.), and the Department of Infectious Diseases, Zhongshan Hospital (B.H.), Fudan University, State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences (J.S., Y.X.), and the Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, and Key Laboratory of Carcinogenesis and Cancer Invasion of the Ministry of Education (J.F.), Shanghai, the Second Hospital of Nanjing (C.C.), Jiangsu Simcere Pharmaceutical (R.T.), and State Key Laboratory of Neurology and Oncology Drug Development (R.T.), Nanjing, the First Affiliated Hospital of Xiamen University, Xiamen (X. Yao), Guizhou Provincial People's Hospital, Guiyang (X. Ye, H.Z.), the Second Department of Infection, Shandong Public Health Clinical Center, Jinan (C.L.), Xuzhou Infectious Diseases Hospital, Xuzhou (Chunying Wang), and Central People's Hospital of Zhanjiang, Zhanjiang (Z.Y.) - all in China.
口服蛋白酶抑制剂Simnotrelvir显著减少了COVID-19患者的症状持续时间. 用simnotrelvir加上ritonavir早期治疗为2019年冠状病毒病提供了一个有前途的治疗选择.
科学领域:
- 病毒学 病毒学
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 辛诺特雷尔维尔是一种口服3 - 胆胺类蛋白酶抑制剂,在体外已证明对SARS-CoV-2的活性.
- 之前的1B期试验表明simnotrelvir在治疗COVID-19中的潜在疗效.
研究的目的:
- 为了评估simnotrelvir加里托纳维尔在轻度至中度COVID-19患者的疗效和安全性.
- 确定早期simnotrelvir给药对症状缓解时间和病毒载荷的影响.
主要方法:
- 这是一项2-3期,双盲,随机,安慰剂对照试验,涉及1208名患有轻度至中度COVID-19的患者.
- 患者每天接受750毫克西蒙特雷尔维尔加100毫克里托纳维尔或安慰剂两次,持续5天,在症状出现后72小时内开始治疗.
- 主要终点是症状持续消失的时间;病毒载量和不良事件也被评估.
主要成果:
- 与安慰剂相比,simnotrelvir显著缩短了持续症状缓解的时间 (180.1小时 vs 216.0小时).
- 在simnotrelvir组中,在第5天观察到病毒载荷的更大降低.
- 副作用的发生率在simnotrelvir组 (29.0%) 较高,但大多是轻度或中度.
结论:
- 早期使用simnotrelvir加上里托纳维尔有效地缩短了成年COVID-19患者的症状持续时间.
- 该疗法表现出可接受的安全性,这表明它是一种可行的治疗选择.
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