停止COVID 2研究:用于COVID-19症状的门诊患者的弗卢沃胺与安慰剂,完全远程随机对照试验
Angela M Reiersen1, Caline Mattar2, Rachel A Bender Ignacio3,4
1Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.
Open forum infectious diseases
|August 25, 2023
概括
弗卢沃胺在未接种疫苗的COVID-19门诊患者中没有防止临床恶化. 这项针对严重急性呼吸系统综合征冠状病毒2 (SARS-CoV-2) 的试验由于病例发生率低而提前停止.
科学领域:
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 之前的试验表明,黄素对患有严重急性呼吸系统综合征冠状病毒2 (SARS-CoV-2) 的患者有好处.
- 这项研究研究了fluvoxamine在预防高风险COVID-19门诊患者的临床恶化方面的疗效.
研究的目的:
- 为了评估弗卢沃胺是否能预防非住院COVID-19患者的临床恶化.
- 评估fluvoxamine在治疗轻度至中度COVID-19中的安全性和有效性.
主要方法:
- 一个随机,双盲,安慰剂控制的远程试验,涉及547名参与者.
- 参与者接受了弗卢沃胺或安慰剂治疗15天,从症状出现后7天内开始.
- 主要结局是15天内临床恶化,由呼吸短促和低氧和度定义.
主要成果:
- 临床恶化发生在4.8%的fluvoxamine组和5.5%的安慰剂组.
- 由于事件发生率低于预期和参与者积累率下降,试验因徒劳而提前停止.
- 在弗卢沃胺和安慰剂组之间没有观察到临床恶化的统计学上显著差异.
结论:
- 弗卢沃胺在预防COVID-19症状的未接种疫苗的门诊患者的临床恶化方面没有被发现是有效的.
- 由于初级结局率较低,该试验不足以检测出有意义的影响.
- 可能需要进一步的研究来探索黄胺在特定患者群体或早期疾病阶段的作用.
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