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

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.
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DOI:
10.1038/s41467-023-43644-x
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发表时间:
2024-01-31
影响因子:
16.6
通讯作者:
Landray, Martin J.
Landray, Martin J.
中科院分区:
综合性期刊1区
文献类型:
--
作者:
Horby, Peter W.;Peto, Leon;Staplin, Natalie;Campbell, Mark;Pessoa-Amorim, Guilherme;Mafham, Marion;Emberson, Jonathan R.;Stewart, Richard;Prudon, Benjamin;Uriel, Alison;Green, Christopher A.;Dhasmana, Devesh J.;Malein, Flora;Majumdar, Jaydip;Collini, Paul;Shurmer, Jack;Yates, Bryan;Baillie, J. Kenneth;Buch, Maya H.;Day, Jeremy;Faust, Saul N.;Jaki, Thomas;Jeffery, Katie;Juszczak, Edmund;Knight, Marian;Lim, Wei Shen;Montgomery, Alan;Mumford, Andrew;Rowan, Kathryn;Thwaites, Guy;Haynes, Richard;Landray, Martin J.

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富马酸二甲酯(DMF)可抑制炎症小体介导的炎症,已被建议用于治疗新冠肺炎患者。这项随机、对照、开放标签的平台试验(新冠肺炎疗法的随机评估[恢复])正在评估因新冠肺炎而住院的患者的多种治疗(NCT04381936,ISRCTN50189673)。在这项在英国27家医院进行的DMF评估中,成年人被随机分配(1:1)到普通护理标准单独或通常护理标准加DMF。主要结果是第5天的临床状态,按7分顺序评分。次要结果是临床状态持续改善的时间、出院时间、第5天外周血氧分压、第5天C反应蛋白和第10天临床状况的改善。在2021年3月2日至2021年11月18日期间,713名患者参加了DMF评估,其中356名患者被随机分配接受常规护理加DMF,357名患者仅接受常规护理。95%的患者接受了皮质类固醇作为常规护理的一部分。没有证据表明DMF对第5天的临床状态有好处(不良结局的常见优势比为1.12;95%可信区间为0.86-1.47;p = 为0.40)。DMF对任何次要结果均无显著影响。富马酸二甲酯(DMF)是一种抗炎药物,被推荐用于治疗COVID19。这里报道了一项随机试验的结果,该试验测试了713名新冠肺炎患者的DMF治疗。DMF与第5天结果的任何改善无关。
Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome. Dimethyl fumarate (DMF) is an anti-inflammatory drug proposed as a treatment for COVID19. Here the results are reported from a randomised trial testing DMF treatment in 713 patients hospitalised with COVID-19. DMF was not associated with any improvement in day 5 outcomes.
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