AimsThe PARACOR‐19 randomized controlled trial (RCT) was designed to examine the effects of sacubitril/valsartan on markers of cardiac injury, inflammation, structure, and function among patients who have recovered from acute coronavirus disease 2019 (COVID‐19) infection.Methods and resultsPARACOR‐19 was a single‐centre, double‐blind RCT of patients with cardiovascular risk factors and a history of COVID‐19 infection 4–16 weeks prior to enrolment. Patients were randomized to sacubitril/valsartan (titrated to the maximum dose of 97/103 mg twice daily) versus matching placebo. Co‐primary endpoints were change from baseline to 12 weeks in high‐sensitivity cardiac troponin T (hs‐cTnT) and soluble ST2 (sST2). Exploratory endpoints included change from baseline to 12 weeks in additional circulating biomarkers. Overall, 42 patients were randomized between August 2021 and March 2023 (n = 20 sacubitril/valsartan, n = 22 placebo). Median (25th–75th) time from COVID‐19 diagnosis to enrolment was 67 (48–80) days. Median age was 67 (62–71) years, 48% were female, and 91% were White. Compared with placebo, sacubitril/valsartan did not have a significant effect on the co‐primary endpoints of change from baseline in hs‐TnT and sST2 (all p ≥ 0.29). In exploratory analyses, sacubitril/valsartan led to a 46% greater reduction in N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) and 51% greater reduction in C‐terminal telopeptide of collagen type I (CITP). Permanent drug discontinuation occurred in four patients in the sacubitril/valsartan group and three patients in the placebo group. There were no deaths and one patient was hospitalized in each group.ConclusionIn this pilot RCT of patients who recovered from acute COVID‐19, sacubitril/valsartan did not lower hs‐cTnT or sST2 compared with placebo. Exploratory analyses suggested potential benefits of sacubitril/valsartan on cardiac wall stress and collagen turnover as measured by NT‐proBNP and CITP. Sacubitril/valsartan was well tolerated.Clinical Trial Registration: ClinicalTrials.gov NCT04883528.

中文翻译：

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近期感染 COVID-19 的患者中沙库巴曲/缬沙坦和心血管生物标志物：PARACOR-19 随机临床试验

目的 PARACOR-19 随机对照试验 (RCT) 旨在检查沙库巴曲/缬沙坦对 2019 年急性冠状病毒病 (COVID-19) 感染康复患者心脏损伤标志物、炎症、结构和功能的影响。 方法结果 PARACOR-19 是一项单中心、双盲 RCT，受试者为具有心血管危险因素且入组前 4-16 周有 COVID-19 感染史的患者。患者被随机分配至沙库巴曲/缬沙坦组（每日两次滴定至最大剂量 97/103 mg）与匹配的安慰剂组。共同主要终点是高敏心肌肌钙蛋白 T (hs-cTnT) 和可溶性 ST2 (sST2) 从基线到 12 周的变化。探索性终点包括其他循环生物标志物从基线到 12 周的变化。总体而言，2021 年 8 月至 2023 年 3 月期间，42 名患者被随机分组​​（n= 20 沙库巴曲/缬沙坦，n= 22 安慰剂）。中位数（25-75th）从 COVID-19 诊断到入组的时间为 67 (48–80) 天。中位年龄为 67 (62–71) 岁，48% 为女性，91% 为白人。与安慰剂相比，沙库巴曲/缬沙坦对 hs-TnT 和 sST2 较基线变化的共同主要终点没有显着影响（所有p≥0.29）。在探索性分析中，沙库巴曲/缬沙坦导致 N 端 B 型利钠肽原 (NT-proBNP) 减少 46%，C 端 I 型胶原端肽 (CITP) 减少 51%。沙库巴曲/缬沙坦组的 4 名患者和安慰剂组的 3 名患者发生永久停药。每组均无死亡病例，且有 1 名患者住院。 结论 在这项针对急性 COVID-19 康复患者的试点随机对照试验中，与安慰剂相比，沙库巴曲/缬沙坦并未降低 hs-cTnT 或 sST2。探索性分析表明，通过 NT-proBNP 和 CITP 测量，沙库巴曲/缬沙坦对心壁应力和胶原蛋白周转有潜在益处。沙库巴曲/缬沙坦耐受性良好。临床试验注册：ClinicalTrials.gov NCT04883528。