后急性COVID-19结果,包括参与者报告的长期COVID:amubarvimab/romlusevimab与安慰剂相比,在ACTIV-2试验中
Teresa H Evering1, Carlee Moser2, Nikolaus Jilg3
1Weill Cornell Medicine, New York, NY, USA.
EClinicalMedicine
|September 10, 2024
概括
早期使用amubarvimab/romlusevimab的COVID-19单克隆抗体治疗没有降低长期COVID风险. 虽然这种治疗有效防止住院和死亡,但它没有影响高风险成年人的长期症状发展.
科学领域:
- 传染性疾病 传染性疾病
- 病毒学 病毒学
- 临床试验 临床试验
背景情况:
- 早期COVID-19单克隆抗体 (mAb) 治疗在预防长期COVID的有效性仍然不确定.
- 之前使用的阿穆巴维马布/罗姆卢塞维马布显示,住院/死亡风险降低了79%.
- 这项研究调查了amubarvimab/romlusevimab对COVID-19晚期结果的影响,包括长期COVID.
研究的目的:
- 评估早期使用amubarvimab/romlusevimab治疗是否可以降低患长期COVID的风险.
- 评估amubarvimab/romlusevimab对复合结果的影响,包括长期COVID,住院或36周死亡.
主要方法:
- 一个随机的,双盲的,安慰剂控制的2/3期试验,涉及非住院的,高风险的成年人在COVID-19症状发病后10天内.
- 晚期症状通过参与者填写的日记作为探索性终点进行评估.
- 逆概率加权 (IPW) 用于分析主要复合结果 (长期COVID,住院或36周死亡).
主要成果:
- 在第36周 (wRR=0.70) 之前,阿穆巴维马布/罗姆卢西维马布显著减少了住院/死亡 (4%对13%的安慰剂).
- 然而,在第36周长期COVID的发病率在amubarvimab/romlusevimab组 (16%) 和安慰剂组 (14%) 之间相似.
- 13%的参与者在第36周不完全确定结果.
结论:
- 在高风险的COVID-19患者中,Amubarvimab/romlusevimab治疗有效地预防住院和死亡.
- 这种mAb疗法并没有证明降低患长期COVID的风险.
- 需要进一步的研究和新的干预措施来预防长期COVID.
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