在养老院的PROTECT-CH COVID-19平台试验中的教训
Philip M Bath1,2, Jonathan Ball3, Matthew Boyd4
1Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Health technology assessment (Winchester, England)
|April 11, 2025
概括
这项研究旨在在养老院测试COVID-19的抗病毒药物,但由于疫苗接种成功而停止. 在这种情况下,暴露后预防的作用仍然不清楚.
科学领域:
- 老年医学 老年医学
- 传染性疾病 传染性疾病
- 临床试验 临床试验
背景情况:
- 在2020-2021年,冠状病毒疾病-2019 (COVID-19) 在英国养老院造成了显著的死亡率和发病率.
- 重用抗病毒药物被认为可以减少COVID-19的传播,感染,复制和炎症.
研究的目的:
- 为了比较潜在的抗病毒药物 (ciclesonide,niclosamide) 的安全性和有效性,用于养老院居民的暴露后预防.
- 评估这些抗病毒药物对死亡率,住院和感染率的影响.
主要方法:
- 设计了一个集群随机化,开放标签,盲目的终点平台试验.
- 符合条件的参与者在英国养老院65岁以上,接受抗病毒加标准护理或仅接受标准护理.
- 主要结局是60天内所有原因死亡率,住院或SARS-CoV-2感染的复合结果.
主要成果:
- 该试验于2021年9月停止,原因是养老院的疫苗接种率很高,这大大减少了感染.
- 在英国养老院开发了大型临床试验的基础设施,但没有测试药物疗效的可行性.
- 许多后勤延误,包括合同和监管障碍,影响了试验的启动.
结论:
- 疫苗接种的成功使得该试验无法评估COVID-19在护理院居民中的暴露后预防的作用.
- 在建立研究基础设施和专业知识方面取得了重大进展,以便在这种环境下进行未来的试验.
- 对于未来的护理之家研究,迫切需要消除后勤障碍,可能通过一项疫情准备的平台试验.
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