在住院儿童中治疗COVID-19的Remdesivir:一项2/3期研究
Amina Ahmed1,2, Flor M Munoz3,4, William J Muller5,6
1Department of Pediatrics, Levine Children's Hospital at Atrium Health, Charlotte, North Carolina.
Pediatrics
|February 9, 2024
概括
雷梅西维尔 (Veklury) 在患有COVID-19的儿童中显示出与成年人相似的安全概况. 儿科用剂量提供了可比的药物暴露,表明其在年轻人群中的潜在使用.
科学领域:
- 儿童传染病 儿童传染病
- 药理学和治疗学 药理学和治疗学
- 病毒学 病毒学
背景情况:
- 雷梅西维尔是一种用于治疗SARS-CoV-2感染的抗病毒药物.
- 它在成年人中的有效性和安全性已经确立,但在儿童群体中的数据是有限的.
- 了解雷梅西维尔的药理动力学和儿童的安全性对于适当的治疗至关重要.
研究的目的:
- 评估Remdesivir在患有COVID-19的婴儿和儿童住院时的安全性和药理动力学.
- 为了将儿科患者的药物暴露与成熟的成人数据进行比较.
主要方法:
- 这是一项开放式的2/3期试验,涉及53名28天至17岁的儿童,确诊感染SARS-CoV-2.
- 静脉注射雷梅西维尔每天服用一次,长达10天,剂量取决于体重.
- 人口的药理动力学分析被用来评估remdesivir及其代谢物.
主要成果:
- 雷梅西维尔治疗一般耐受良好,没有发现新的安全问题.
- 两名参与者因不良事件 (转氨基酶升高) 暂停治疗,两人都有先前存在的升高水平.
- 儿童药物暴露 (AUCτ,Cmax,Cτ) 与成人数据在很大程度上重叠,一些参数略有增加.
结论:
- 在COVID-19的儿科患者中评估的雷梅西维尔剂量导致与成年人相比的药物暴露.
- 这项研究表明,雷梅西维尔可以安全地用于婴儿和儿童,尽管需要在更大的队列中进行进一步的研究.
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