NEJM:新冠抗体鸡尾酒疗法REGEN-COV III期临床研究结果喜人

2021-12-07 MedSci原创 MedSci原创

截至2021年9月,SARS-CoV-2导致的Covid-19已造成2.3亿人感染,470万人死亡。虽然大多数Covid-19患者症状轻微,仅在门诊接受治疗,但仍有部分患者重症住院或死亡。新冠抗体鸡尾

截至2021年9月,SARS-CoV-2导致的Covid-19已造成2.3亿人感染,470万人死亡。虽然大多数Covid-19患者症状轻微,仅在门诊接受治疗,但仍有部分患者重症住院或死亡。新冠抗体鸡尾酒疗法REGEN-COV于2020年11月获FDA授予紧急使用授权(EUA),在I-II期研究中,REGEN-COV治疗可降低患者病毒载量和就诊次数。近日研究人员公布了了REGEN-COV治疗新冠肺炎III期临床研究结果。

本次研究为III期临床研究,Covid-19门诊患者参与,患者存在重症进展风险因素,随机接受不同剂量的静脉注射ReGE-COV或安慰剂,随访29天。研究的主要终点为新冠肺炎住院或死亡以及临床症状缓解时间。

REGEN-COV 2400-mg组1355名患者中18人(1.3%)因新冠肺炎住院或死亡,而相应安慰剂组1341名患者中,62人(4.6%)因新冠肺炎住院或死亡(患者住院或死亡风险降低71.3%)。REGEN-COV 1200-mg组736名患者中7人(1.0%)因新冠肺炎住院或死亡,而相应安慰剂组748名患者中,24人(3.2%)因新冠肺炎住院或死亡(患者住院或死亡风险降低70.4%)。REGEN-COV组治疗后平均症状消失时间较安慰剂组短4天(10 vs 14天)。REGEN-COV治疗在各亚组中均表现出良好效果,包括基线血清学阳性人群。与安慰剂相比,REGEN-COV治疗可快速降低病毒载量。安慰剂组的不良事件高于REGEN-COV组(4.0% vs 1.1-1.3%),各组2级及以上输注相关不良事件率均不到0.3%。

REGEN-COV治疗后患者住院或死亡风险降低

研究发现,REGEN-COV治疗可降低Covid-19相关住院或死亡风险,可快速缓解患者症状并降低病毒载量

原始出处:

David M. Weinreich et al. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med,December 2,2021.

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    2022-05-25 juliusluan78
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  8. 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    2021-12-09 qblt
  9. 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createdName=智智灵药, createdTime=Thu Dec 09 10:24:57 CST 2021, time=2021-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1077958, encodeId=558610e7958dc, content=在门诊接受治疗,但仍有部分患者重, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIrrxxDxnLic8t6EAs38Qfwo6H2h6JMleIgb9OSYf6LMnVDkQEqUXWoSDWboibjhOBI9SJDTXweqQIA/132, createdBy=50aa5321359, createdName=查查佳佳, createdTime=Wed Dec 08 07:16:50 CST 2021, time=2021-12-08, status=1, ipAttribution=)]
    2021-12-08 查查佳佳

    在门诊接受治疗,但仍有部分患者重

    0

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