4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
3rd Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
Nat Med. 2021 Oct;27(10):1752-1760. doi: 10.1038/s41591-021-01499-z. Epub 2021 Sep 3.
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, 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.
早期可溶性尿激酶型纤溶酶原激活物受体（suPAR）血清水平升高提示 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 anakinra（一种 IL-1α/β 抑制剂）在 594 例 COVID-19 患者中的疗效和安全性，这些患者的血浆 suPAR≥6ng/ml，85.9%（n=510）正在接受地塞米松治疗。在第 28 天，与安慰剂相比，anakinra 使临床状况恶化（通过 11 分制世界卫生组织临床进展量表（WHO-CPS）评估）的调整后的优势比为 0.36（95%置信区间为 0.26-0.50）。安慰剂和 anakinra 组在第 28 天从基线的 WHO-CPS 中位数分别下降了 3 点和 4 点（比值比（OR）=0.40，P<0.0001）；第 7 天从基线的Sequential Organ Failure Assessment（SOFA）评分中位数分别下降了 0 点和 1 点（OR=0.63，P=0.004）。28 天死亡率降低（风险比=0.45，P=0.045），住院时间缩短。
