Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
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恩格列净治疗 COVID-19 入院患者(恢复):一项随机、对照、开放标签平台试验

DOI:
10.1101/2023.04.13.23288469
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发表时间:
2023
期刊:
--
影响因子:
--
通讯作者:
Horby P
Horby P
中科院分区:
--
文献类型:
--
作者:
Horby P

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背景恩帕格利氟秦因其抗炎、代谢和血流动力学作用而被建议用于新冠肺炎的治疗。RECOVE试验旨在评估其在新冠病毒感染的住院患者中的安全性和有效性。方法在随机、对照、开放标签的恢复试验中,对新冠肺炎患者的几种可能的治疗方法进行了比较。在这项分析中,我们评估了符合条件和同意的成年人,他们以1:1的比例随机分配到通常的护理标准单独或通常的护理标准加口服依帕利嗪10毫克,持续28天,或者直到出院(无论哪个先来),使用基于网络的简单(未分层)随机分配隐藏分配。主要结果是28天的死亡率;次要结果是住院时间和(基线时不接受有创机械通气的受试者)有创机械通气或死亡的综合结果。2023年3月3日,独立数据监测委员会建议调查人员审查数据,因此于2023年3月7日停止招聘。正在进行的恢复试验在ISRCTN(50189673)和临床试验中注册。政府(NCT04381936)。
BackgroundEmpagliflozin has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory, metabolic, and haemodynamic effects. The RECOVERY trial aimed to assess its safety and efficacy in patients admitted to hospital with COVID-19.MethodsIn the randomised, controlled, open-label RECOVERY trial, several possible treatments are compared with usual care in patients hospitalised with COVID-19. In this analysis, we assess eligible and consenting adults who were randomly allocated in a 1: 1 ratio to either usual standard of care alone or usual standard of care plus oral empagliflozin 10 mg once daily for 28 days or until discharge (whichever came first) using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality; secondary outcomes were duration of hospitalisation and (among participants not on invasive mechanical ventilation at baseline) the composite of invasive mechanical ventilation or death. On March 3, 2023 the independent data monitoring committee recommended that the investigators review the data and recruitment was consequently stopped on March 7, 2023. The ongoing RECOVERY trial is registered with ISRCTN (50189673) and ClinicalTrials. gov (NCT04381936).
DOI: 10.1016/s0140-6736(22)01109-6
发表时间: 2022-07-30
期刊: Lancet (London, England)
影响因子: --
作者:
通讯作者: --
DOI: 10.1002/jmv.26771
发表时间: 2021-02-23
影响因子: 12.7
作者:
Wang, Jun-Hong;Chen, Ru-Dong;Li, Hua
通讯作者: Li, Hua
DOI: 10.1016/s0140-6736(21)00897-7
发表时间: 2021-05-29
期刊: Lancet (London, England)
影响因子: --
作者:
RECOVERY Collaborative Group
通讯作者: RECOVERY Collaborative Group