预防SARS-CoV-2感染的阿泽拉斯鼻喷剂:一项2期随机临床试验
Thorsten Lehr1, Peter Meiser2, Dominik Selzer1
1Saarland University, Saarbruecken, Germany.
JAMA internal medicine
|September 2, 2025
概括
在临床试验中,阿泽拉斯鼻雾剂显著降低了SARS-CoV-2感染的风险. 这种抗胺药可以作为预防COVID-19的安全预暴露剂 (PEP),补充疫苗接种策略.
科学领域:
- 病毒学
- 传染性疾病
- 药理学
背景情况:
- 除了接种疫苗之外,对于COVID-19暴露前预防 (PEP) 有有限的药物选择.
- 阿泽拉斯是一种已知抗胺鼻雾剂,在体外表现出对SARS-CoV-2的抗病毒活性.
- 这项研究调查了azelastine作为预防呼吸道病毒感染的潜力.
研究的目的:
- 评估阿泽拉斯鼻雾剂在健康成年人中预防SARS-CoV-2感染的有效性和安全性.
- 评估azelastine对SARS-CoV-2感染的发生率和持续时间的影响.
- 探索azelastine对其他呼吸道病毒感染的影响,如鼻病毒.
主要方法:
- 一个双盲,安慰剂控制的单中心试验,涉及450名健康成年人.
- 参与者接受了阿泽拉斯 (0. 1%) 或安慰剂鼻雾剂每天三次,持续56天.
- 通过快速抗原测试监测SARS-CoV-2感染并通过PCR确认;使用多重PCR测试其他呼吸道病毒.
主要成果:
- 与安慰剂 (6. 7%) 相比,azelastine组中PCR确认的SARS-CoV-2感染的发生率明显较低.
- 阿泽拉斯增加了感染的平均时间 (31.2天而不是19.5天),并减少了症状性感染.
- 艾泽拉斯也显示PCR确认的鼻病毒感染的发病率较低 (1.8%对6.3%),不同组的不良反应相似.
结论:
- 在这项试验中,阿泽拉斯鼻雾与SARS-CoV-2呼吸道感染的风险降低有关.
- 研究结果表明,阿泽拉斯是预防COVID-19的潜在安全预防方法.
- 需要进行更大规模的多中心试验来证实这些有希望的结果.
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