Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial
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Published:2021-09-03
Issue:10
Volume:27
Page:1752-1760
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ISSN:1078-8956
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Container-title:Nature Medicine
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language:en
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Short-container-title:Nat Med
Author:
Kyriazopoulou EvdoxiaORCID, Poulakou Garyfallia, Milionis Haralampos, Metallidis Simeon, Adamis Georgios, Tsiakos KonstantinosORCID, Fragkou Archontoula, Rapti Aggeliki, Damoulari Christina, Fantoni MassimoORCID, Kalomenidis IoannisORCID, Chrysos Georgios, Angheben AndreaORCID, Kainis Ilias, Alexiou Zoi, Castelli Francesco, Serino Francesco Saverio, Tsilika Maria, Bakakos Petros, Nicastri Emanuele, Tzavara Vassiliki, Kostis Evangelos, Dagna LorenzoORCID, Koufargyris PanagiotisORCID, Dimakou Katerina, Savvanis Spyridon, Tzatzagou Glykeria, Chini Maria, Cavalli Giulio, Bassetti Matteo, Katrini Konstantina, Kotsis Vasileios, Tsoukalas George, Selmi Carlo, Bliziotis Ioannis, Samarkos MichaelORCID, Doumas Michael, Ktena Sofia, Masgala Aikaterini, Papanikolaou IliasORCID, Kosmidou MariaORCID, Myrodia Dimitra-Melia, Argyraki Aikaterini, Cardellino Chiara Simona, Koliakou Katerina, Katsigianni Eleni-Ioanna, Rapti Vassiliki, Giannitsioti Efthymia, Cingolani Antonella, Micha Styliani, Akinosoglou Karolina, Liatsis-Douvitsas OrestisORCID, Symbardi Styliani, Gatselis Nikolaos, Mouktaroudi Maria, Ippolito GiuseppeORCID, Florou EleniORCID, Kotsaki Antigone, Netea Mihai G.ORCID, Eugen-Olsen JesperORCID, Kyprianou MiltiadesORCID, Panagopoulos Periklis, Dalekos George N., Giamarellos-Bourboulis Evangelos J.ORCID
Abstract
AbstractEarly 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.
Funder
Hellenic Institute for the Study of Sepsis Swedish Orphan BioVitrum AB
Publisher
Springer Science and Business Media LLC
Subject
General Biochemistry, Genetics and Molecular Biology,General Medicine
Cited by
404 articles.
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