奥尔戈特雷尔维尔作为一种单剂治疗COVID-19的非住院患者
Rongmeng Jiang1, Bing Han1, Wanhong Xu2
1Beijing Ditan Hospital Capital Medical University, China.
NEJM evidence
|May 28, 2024
概括
口服抗病毒药物Olgotrelvir在轻度至中度的COVID-19患者中显著加快了症状恢复. 这种双重作用药物在降低病毒载量方面表现出有效性,并具有可控的副作用.
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:
- 奥尔戈特雷尔维尔是一种口服抗病毒药物,具有双重作用机制,向SARS-CoV-2主要蛋白酶 (Mpro) 和人类甲素L.
- 它作为治疗2019年新冠肺炎疾病 (COVID-19) 的单一疗法具有潜力.
研究的目的:
- 评估与安慰剂相比,奥尔戈特雷尔维尔的疗效和安全性,在非住院的成年患者中,患者患有轻度至中度的COVID-19.
- 主要终点包括持续症状恢复的时间和病毒核糖核酸 (RNA) 负载的减少.
主要方法:
- 一个第三阶段,双盲,随机,安慰剂对照试验,涉及1212名参与者.
- 参与者每天两次口服600毫克的Olgotrelvir或安慰剂,持续5天.
- 通过治疗出现的不良事件的发生率来评估安全性.
主要成果:
- 与安慰剂 (264小时) 相比,在olgotrelvir组 (205小时) 中,症状恢复的中位时间明显较短 (P<0.001).
- 与安慰剂相比,奥尔戈特雷尔维尔治疗在第四天导致病毒RNA负载的减少更大.
- 最常见的不良事件是皮疹和恶心;没有报告严重的治疗相关不良事件或死亡.
结论:
- 作为单剂疗法,奥尔戈特雷尔维尔显著提高了COVID-19患者的症状恢复.
- 观察到的不良反应并没有限制剂量,这表明了有利的安全性.
- 这项研究由索伦托疗法公司资助,并以ClinicalTrials.gov号NCT05716425.gov注册.
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