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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

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  • Evdoxia Kyriazopoulou
  • Garyfallia Poulakou
  • Haralampos Milionis
  • Simeon Metallidis
  • Georgios Adamis
  • Konstantinos Tsiakos
  • Archontoula Fragkou
  • Aggeliki Rapti
  • Christina Damoulari
  • Massimo Fantoni
  • Ioannis Kalomenidis
  • Georgios Chrysos
  • Andrea Angheben
  • Ilias Kainis
  • Zoi Alexiou
  • Francesco Castelli
  • Francesco Saverio Serino
  • Maria Tsilika
  • Petros Bakakos
  • Emanuele Nicastri
  • Vassiliki Tzavara
  • Evangelos Kostis
  • Lorenzo Dagna
  • Panagiotis Koufargyris
  • Katerina Dimakou
  • Spyridon Savvanis
  • Glykeria Tzatzagou
  • Maria Chini
  • Giulio Cavalli
  • Matteo Bassetti
  • Konstantina Katrini
  • Vasileios Kotsis
  • George Tsoukalas
  • Carlo Selmi
  • Ioannis Bliziotis
  • Michael Samarkos
  • Michael Doumas
  • Sofia Ktena
  • Aikaterini Masgala
  • Ilias Papanikolaou
  • Maria Kosmidou
  • Dimitra-Melia Myrodia
  • Aikaterini Argyraki
  • Chiara Simona Cardellino
  • Katerina Koliakou
  • Eleni-Ioanna Katsigianni
  • Vassiliki Rapti
  • Efthymia Giannitsioti
  • Antonella Cingolani
  • Styliani Micha
  • Karolina Akinosoglou
  • Orestis Liatsis-Douvitsas
  • Styliani Symbardi
  • Nikolaos Gatselis
  • Maria Mouktaroudi
  • Giuseppe Ippolito
  • Eleni Florou
  • Antigone Kotsaki
  • Mihai G Netea
  • Jesper Eugen-Olsen
  • Miltiades Kyprianou
  • Periklis Panagopoulos
  • George N Dalekos
  • Evangelos J Giamarellos-Bourboulis
Vis graf over relationer

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.

OriginalsprogEngelsk
TidsskriftNature Medicine
Vol/bind27
Udgave nummer10
Sider (fra-til)1752-1760
Antal sider9
ISSN1078-8956
DOI
StatusUdgivet - okt. 2021

ID: 67609433