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设计和优化长期COVID的临床试验

Julia Moore Vogel¹, Beth Pollack², Ezra Spier³

¹Scripps Research Translational Institute, Scripps Research, La Jolla, CA, United States of America; Patient-Led Research Collaborative, United States of America.

|August 14, 2024

概括

长期COVID的临床试验不足,通常专注于未经证实的非药物治疗方法. 优先考虑药物干预和严格,可访问的研究设计对于理解和治疗这种慢性疾病至关重要.

科学领域:

传染性疾病传染性疾病
临床试验临床试验
慢性疾病研究慢性疾病研究

背景情况:

长期COVID是一种SARS-CoV-2感染后的多系统性疾病,缺乏足够的临床试验数据,超过四年进入大流行.
长期COVID的现有临床试验显示出不同的严谨性和重点,大多数测试的非药物干预缺乏强有力的证据.

研究的目的:

分析长期COVID临床试验的情况.
发现当前研究方法的缺陷.
为改善未来长期COVID和感染相关慢性疾病和疾病 (IACCI) 临床试验提出准则.

主要方法:

从ClinicalTrials.gov对长期COVID和IACCI试验的数据进行分析.
审查现有的试验设计,干预措施和方法.
根据发现的差距和有希望的正在进行的试验,制定建议.

主要成果:

目前大多数长期COVID试验都测试了缺乏足够证据的非药物干预措施.
目前正在进行的临床试验的严格性和重点存在显著的变化.
有前途的试验正在进行中,但需要采取更广泛,更严格的方法.

结论:

药物试验具有潜在的治疗干预措施,包括药物重新定位和新开发,应优先考虑长期COVID.
建议严格,可访问的研究设计 (例如,远程三盲随机试验) 和包含相关IACCI的比较群体.
纳入/排除标准的公平性和患者研究人员的整合对于有影响力的长期COVID研究至关重要.

关键词:

临床试验中的临床试验.长时间的COVID.患者主导的研究.在COVID的后急性后果.

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