对于COVID-19 (Hydro-COVID) 门诊患者的分子:一个第三阶段随机,三盲,实用,安慰剂控制,多中心试验
Yoann Gaboreau1, Aleksandra Milovančev2, Carole Rolland1
1CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, UMR5525, University Grenoble Alpes, 38700 Grenoble, France.
Journal of clinical medicine
|August 10, 2024
概括
富含的水 (HRW) 并没有防止COVID-19患者的临床恶化. 这项研究发现,HRW与安慰剂在减少疾病进展或不良事件方面没有显著差异.
科学领域:
- 生物医学研究的研究.
- 临床试验中的临床试验.
- 呼吸系统药物 呼吸系统药物
背景情况:
- 分子 (H2) 具有抗氧化,抗炎和抗解性质.
- 正在探索H2对2019年新冠病毒病 (COVID-19) 的潜在治疗应用.
- 富含的水 (HRW) 是一种H2的输送方法,具有潜在的好处.
研究的目的:
- 评估HRW在减少COVID-19进展方面的有效性和安全性.
- 确定HRW是否可以预防轻度至中度COVID-19患者的临床恶化.
主要方法:
- 第三阶段,三重盲目的,随机的,安慰剂对照试验.
- 675名实验室确认COVID-19的参与者每天两次接受HRW或安慰剂,持续21天.
- 主要终点包括临床恶化和不良事件.
主要成果:
- 在预防14日临床恶化方面,HRW并不优于安慰剂 (46.1%对43.5%).
- 临床恶化的危险比为1.09 (90% CI [0.90-1.31]).
- 在两组中观察到相似的不良事件率和低死亡率.
结论:
- 在21天的时间里,HRW每天两次给药并没有减少COVID-19患者的临床恶化.
- 该研究没有支持HRW作为预防轻度至中度COVID-19进展的治疗方法.
- 可能需要进一步的研究来探索H2在其他条件或不同剂量的作用.
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