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. The SAVE-MORE phase 3 study demonstrates the efficacy of anakinra, an IL-1α/β inhibitor, in patients with COVID-19 and high serum levels of soluble plasminogen activator receptor.
【초록키워드】 COVID-19, Dexamethasone, Randomized controlled trial, coronavirus disease, Coronavirus disease 2019, Efficacy, Respiratory failure, Mortality, Anakinra, suPAR, risk, progression, clinical status, clinical, Efficacy and safety, Placebo, SOFA, receptor, scale, assessment, group, Odds ratio, Hospital stay, Health Organization, soluble urokinase plasminogen activator receptor, World Health Organization, Serum level, increased risk, failure, hazard ratio, 11-point World Health Organization Clinical Progression Scale, adjusted proportional odds, IL-1α/β, IL-1α/β inhibitor, plasma suPAR, SAVE, SAVE-MORE double-blind, WHO-CPS, phase 3 study, decrease, evaluated, receiving, median, adjusted proportional odd, baseline, patients with COVID-19, SAVE-MORE, 【제목키워드】 COVID-19, Treatment, Randomized, phase 3 trial, plasma, receptor, double-blind,