TY - JOUR
TI - Early treatment of COVID-19 with anakinra guided by soluble urokinase
plasminogen receptor plasma levels: a double-blind, randomized
controlled phase 3 trial
AU - Kyriazopoulou, Evdoxia
AU - Poulakou, Garyfallia
AU - Milionis, Haralampos
AU - and Metallidis, Simeon
AU - Adamis, Georgios
AU - Tsiakos, Konstantinos
AU - and Fragkou, Archontoula
AU - Rapti, Aggeliki
AU - Damoulari, Christina
AU - and Fantoni, Massimo
AU - Kalomenidis, Ioannis
AU - Chrysos, Georgios and
AU - Angheben, Andrea
AU - Kainis, Ilias
AU - Alexiou, Zoi
AU - Castelli,
AU - Francesco
AU - Serino, Francesco Saverio
AU - Tsilika, Maria
AU - Bakakos,
AU - Petros
AU - Nicastri, Emanuele
AU - Tzavara, Vassiliki
AU - Kostis,
AU - Evangelos
AU - Dagna, Lorenzo
AU - Koufargyris, Panagiotis
AU - Dimakou,
AU - Katerina
AU - Savvanis, Spyridon
AU - Tzatzagou, Glykeria
AU - Chini, Maria
AU - and Cavalli, Giulio
AU - Bassetti, Matteo
AU - Katrini, Konstantina and
AU - Kotsis, Vasileios
AU - Tsoukalas, George
AU - Selmi, Carlo
AU - Bliziotis,
AU - Ioannis
AU - Samarkos, Michael
AU - Doumas, Michael
AU - Ktena, Sofia and
AU - Masgala, Aikaterini
AU - Papanikolaou, Ilias
AU - Kosmidou, Maria and
AU - Myrodia, Dimitra-Melia
AU - Argyraki, Aikaterini
AU - Cardellino, Chiara
AU - Simona
AU - Koliakou, Katerina
AU - Katsigianni, Eleni-Ioanna
AU - Rapti,
AU - Vassiliki
AU - Giannitsioti, Efthymia
AU - Cingolani, Antonella
AU - Micha,
AU - Styliani
AU - Akinosoglou, Karolina
AU - Liatsis-Douvitsas, Orestis and
AU - Symbardi, Styliani
AU - Gatselis, Nikolaos
AU - Mouktaroudi, Maria and
AU - Ippolito, Giuseppe
AU - Florou, Eleni
AU - Kotsaki, Antigone
AU - Netea,
AU - Mihai G.
AU - Eugen-Olsen, Jesper
AU - Kyprianou, Miltiades and
AU - Panagopoulos, Periklis
AU - Dalekos, George N. and
AU - Giamarellos-Bourboulis, Evangelos J.
JO - Journal of Natural Medicines
PY - 2021
VL - 27
TODO - 10
SP - 1752+
PB - NATURE PORTFOLIO
SN - 1861-0293
TODO - 10.1038/s41591-021-01499-z
TODO - null
TODO - 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-1 alpha/beta 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.
The SAVE-MORE phase 3 study demonstrates the efficacy of anakinra, an
IL-1 alpha/beta inhibitor, in patients with COVID-19 and high serum
levels of soluble plasminogen activator receptor.
ER -