一个Plitidepsin的第三阶段随机对照试验,一种来自海洋的化合物,在住院的成年人中与中度COVID-19进行了随机对照试验
Pedro Landete1,2,3,4, Olga-Adriana Caliman-Sturdza5,6, Jose A Lopez-Martin7
1Pneumology Department, Hospital Universitario La Princesa, Madrid, Spain.
概括
普利提德在治疗需要氧气的中度COVID-19患者方面显示出潜力,观察到更快的氧气吸收. 建议对住院患者的这种抗病毒药物进行进一步的研究.
科学领域:
- 病毒学 病毒学
- 临床医学 临床医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 普利蒂素在临床前对SARS-CoV-2的疗效得到了证明.
- 一个I期试验表明,在住院的COVID-19患者中,plitidepsin耐受性很好.
- 尼普图诺试验旨在评估在中度COVID-19中普立德的疗效和安全性.
研究的目的:
- 为了评估plitidepsin在住院成年患者中适度COVID-19的疗效和安全性.
- 为了确定除了德克萨米他之外的普利蒂辛是否可以改善与标准护理相比的结果.
主要方法:
- 第三阶段,多中心,随机,受控试验 (NEPTUNO).
- 205名中度COVID-19患者需要氧气治疗被随机分组.
- 治疗手臂:德克萨米他加普利蒂素 (每天1.5毫克或2.5毫克3天) 或标准护理.
主要成果:
- 由于COVID-19住院病例减少,该试验被提前中止.
- 观察到plitidepsin (中位数为5天与7天) 的较快氧气吸收趋势.
- 整体而言,plitidepsin的耐受性很好,没有发现任何重大安全问题.
结论:
- 尽管提前终止,结果表明,在中度COVID-19患者中,需要氧气的plitidepsin可能具有积极的益处风险比.
- 需要进一步的研究,特别是在免疫抑制群体中,以探索plitidepsin的治疗潜力.
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