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Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial
Nature Medicine ( IF 58.7 ) Pub Date : 2021-09-03 , DOI: 10.1038/s41591-021-01499-z
Evdoxia Kyriazopoulou 1 , Garyfallia Poulakou 2 , Haralampos Milionis 3 , Simeon Metallidis 4 , Georgios Adamis 5 , Konstantinos Tsiakos 6 , Archontoula Fragkou 7 , Aggeliki Rapti 6 , Christina Damoulari 1 , Massimo Fantoni 8 , Ioannis Kalomenidis 9 , Georgios Chrysos 10 , Andrea Angheben 11 , Ilias Kainis 12 , Zoi Alexiou 13 , Francesco Castelli 14 , Francesco Saverio Serino 15 , Maria Tsilika 1 , Petros Bakakos 16 , Emanuele Nicastri 17 , Vassiliki Tzavara 18 , Evangelos Kostis 19 , Lorenzo Dagna 20 , Panagiotis Koufargyris 1 , Katerina Dimakou 21 , Spyridon Savvanis 7 , Glykeria Tzatzagou 22 , Maria Chini 23 , Giulio Cavalli 20 , Matteo Bassetti 24 , Konstantina Katrini 1 , Vasileios Kotsis 25 , George Tsoukalas 26 , Carlo Selmi 27 , Ioannis Bliziotis 28 , Michael Samarkos 29 , Michael Doumas 30 , Sofia Ktena 1 , Aikaterini Masgala 31 , Ilias Papanikolaou 32 , Maria Kosmidou 3 , Dimitra-Melia Myrodia 2 , Aikaterini Argyraki 33 , Chiara Simona Cardellino 11 , Katerina Koliakou 34 , Eleni-Ioanna Katsigianni 34 , Vassiliki Rapti 2 , Efthymia Giannitsioti 10 , Antonella Cingolani 8 , Styliani Micha 34 , Karolina Akinosoglou 35 , Orestis Liatsis-Douvitsas 34 , Styliani Symbardi 36 , Nikolaos Gatselis 37 , Maria Mouktaroudi 1, 34 , Giuseppe Ippolito 17 , Eleni Florou 34 , Antigone Kotsaki 1 , Mihai G Netea 38, 39 , Jesper Eugen-Olsen 40 , Miltiades Kyprianou 34 , Periklis Panagopoulos 41 , George N Dalekos 37 , Evangelos J Giamarellos-Bourboulis 1, 34
Affiliation  

Early increase of soluble urokinase plasminogen activator receptor (suPAR) serum levels is indicative of increased risk of progression of coronavirus disease 2019 (COVID-19) to respiratory failure. The SAVE-MORE double-blind, randomized controlled trial evaluated the efficacy and safety of anakinra, an IL-1α/β inhibitor, in 594 patients with COVID-19 at risk of progressing to respiratory failure as identified by plasma suPAR ≥6 ng ml−1, 85.9% (n = 510) of whom were receiving dexamethasone. At day 28, the adjusted proportional odds of having a worse clinical status (assessed by the 11-point World Health Organization Clinical Progression Scale (WHO-CPS)) with anakinra, as compared to placebo, was 0.36 (95% confidence interval 0.26–0.50). The median WHO-CPS decrease on day 28 from baseline in the placebo and anakinra groups was 3 and 4 points, respectively (odds ratio (OR) = 0.40, P < 0.0001); the respective median decrease of Sequential Organ Failure Assessment (SOFA) score on day 7 from baseline was 0 and 1 points (OR = 0.63, P = 0.004). Twenty-eight-day mortality decreased (hazard ratio = 0.45, P = 0.045), and hospital stay was shorter.



中文翻译:


以可溶性尿激酶纤溶酶原受体血浆水平为指导,用阿那白滞素早期治疗 COVID-19:一项双盲、随机对照 3 期试验



可溶性尿激酶纤溶酶原激活剂受体 (suPAR) 血清水平的早期升高表明 2019 年冠状病毒病 (COVID-19) 进展为呼吸衰竭的风险增加。 SAVE-MORE 双盲、随机对照试验评估了阿那白滞素(一种 IL-1α/β 抑制剂)在 594 名有进展为呼吸衰竭风险(血浆 suPAR ≥6 ng ml 确定)的 COVID-19 患者中的疗效和安全性−1 ,其中 85.9% ( n = 510) 正在接受地塞米松治疗。在第 28 天,与安慰剂相比,阿那白滞素组出现更差临床状态(通过 11 点世界卫生组织临床进展量表 (WHO-CPS) 评估)的调整后比例几率为 0.36(95% 置信区间 0.26– 0.50)。安慰剂组和阿那白滞素组在第 28 天相对于基线的 WHO-CPS 中值下降分别为 3 点和 4 点(比值比 (OR) = 0.40, P < 0.0001);第 7 天序贯器官衰竭评估 (SOFA) 评分相对于基线的中位下降分别为 0 分和 1 分(OR = 0.63, P = 0.004)。 28 天死亡率下降(风险比 = 0.45, P = 0.045),住院时间缩短。

更新日期:2021-09-03
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