在严重的COVID-19患者中使用Remdesivir:一个随机,双盲,安慰剂控制的多中心试验
Yeming Wang1, Dingyu Zhang2, Guanhua Du3
1Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China.
Lancet (London, England)
|May 20, 2020
概括
在中国的一项试验中,雷梅西维尔 (GS-5734) 对严重的COVID-19患者没有显著的临床益处. 早期的治疗显示出数量上的改善,因此需要在更大的研究中进行进一步的研究.
科学领域:
- 传染性疾病
- 临床医学
- 药理学
背景情况:
- 2019年严重的冠状病毒病 (COVID-19) 缺乏经过验证的抗病毒治疗方法.
- 雷梅西维尔 (GS-5734) 是一种核类型,在体外和体内表现出对冠状病毒,包括SARS-CoV-2的抗病毒活性.
研究的目的:
- 评估雷梅西维尔在严重COVID-19的住院成年患者中的有效性和安全性.
- 确定临床改善的时间作为主要终点.
主要方法:
- 在中国湖北进行了一项随机,双盲,安慰剂控制的多中心试验.
- 237名患有严重COVID-19的成年患者被随机分配 (2:1) 接受静脉注射雷梅西维尔或安慰剂10天.
- 主要终点是28天内临床改善的时间.
主要成果:
- 与安慰剂相比,雷梅西维尔治疗与临床改善的时间没有统计学上显著的差异 (HR 1. 23 [95% CI 0. 87-1.75]).
- 在接受雷梅西维尔治疗的患者中,症状持续时间为10天或更短的患者的临床改善速度呈现了数值趋势 (HR 1.52 [0. 95-2.43]).
- 在接受雷梅西维尔的患者中,12%的不良反应导致早期停止治疗,而在接受安慰剂的患者中,这一比例为5%.
结论:
- 在本次试验中,雷姆德西维尔对严重的COVID-19患者没有显著的临床益处.
- 在早期接受治疗的患者中观察到的数值效益表明需要在更大的试验中进行进一步的研究.
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