尼尔马特里尔维尔用于COVID-19疫苗接种或未接种的成人门诊患者
Jennifer Hammond1, Robert J Fountaine1, Carla Yunis1
1From Global Product Development, Pfizer, Collegeville, PA (J.H.); Global Product Development, Pfizer, Groton, CT (R.J.F.); Global Product Development, Pfizer, Lake Mary (C.Y.), and Global Product Development, Pfizer, Tampa (J.M.R.) - both in Florida; Global Product Development, Pfizer, Lexington, KY (D.F.); Global Product Development, Pfizer, New York (M.A., W.B., R.P.); Global Product Development, Pfizer, Lake Forest, IL (W.W.); Early Clinical Development, Pfizer, Cambridge, MA (M.L.B.); Pfizer, Sandwich, United Kingdom (V.M.H.); the Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases, Haskovo, Bulgaria (V.K.); and Méchnikov Project, Köhler and Milstein Research, Anahuac-Mayab University, Mérida, Mexico (J.A.S.-C.).
与安慰剂相比,涅玛特里尔维尔-里托纳维尔在轻度至中度Covid-19的症状缓解没有显著加快. 这种抗病毒治疗在两组之间显示出相似的住院和死亡率.
科学领域:
- 传染性疾病 传染性疾病
- 病毒学 病毒学
- 临床药理学 临床药理学
背景情况:
- 尼尔马特雷尔维尔 - 里托纳维尔是一种适用于轻度至中度COVID-19的抗病毒药物.
- 它在标准风险或完全接种疫苗的个体中具有严重COVID-19的危险因素的有效性以前没有确立.
研究的目的:
- 评估尼尔马特雷尔维尔 - 里托纳维尔在轻度至中度COVID-19患者的疗效.
- 确定持续缓解症状的时间,并评估住院和死亡率.
主要方法:
- 一个2-3期随机试验,涉及已确诊的COVID-19的成年人,在症状出现后5天内进行.
- 参与者在5天内每12小时接受涅马特雷尔维尔 - 里托纳维尔或安慰剂.
- 主要终点是持续缓解所有针对性的COVID-19迹象和症状的时间.
主要成果:
- 尼尔马特雷尔维尔 - 里托纳维尔治疗症状缓解的中位时间为12天,而安慰剂治疗时间为13天 (P=0.60).
- 住院治疗或死亡发生在0.8%的尼尔马特雷尔维尔 - 里托纳维尔组和1.6%的安慰剂组.
- 副作用的发生率相似,治疗相关的常见事件是腹和腹.
结论:
- 与安慰剂相比,涅玛特里尔维尔-里托纳维尔并没有显著缩短持续缓解症状的时间.
- 该研究没有确定这种抗病毒治疗在受研究的人群中具有显著的益处.
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