Freilich Daniel, Victory Jennifer, Jenkins Paul, Gadomski Anne
Bassett Medical Center, 1 Atwell Rd, Cooperstown, NY, 13326, USA.
Bassett Research Institute, 1 Atwell Rd, Cooperstown, NY, 13326, USA.
Contemp Clin Trials Commun. 2022 Oct;29:100968. doi: 10.1016/j.conctc.2022.100968. Epub 2022 Jul 20.
To assess the efficacy and safety of losartan for COVID-19 patients.
COVIDMED was a double-blinded, placebo-controlled platform RCT. Enrollees were randomized to standard care plus hydroxychloroquine, lopinavir/ritonavir, losartan, or placebo. Hydroxychloroquine and lopinavir/ritonavir arms were discontinued early. We report losartan data vs. combined (lopinavir-ritonavir and placebo) and prespecified placebo-only controls. The primary endpoint was the mean COVID-19 Ordinal Severity Score (COSS) slope of change. Slow enrollment prompted early termination.
Fourteen patients were included in our final analysis (losartan [N = 9] vs. control [N = 5] [lopinavir/ritonavir [N = 2], placebo [N = 3]]). Most baseline parameters were balanced. Losartan treatment was not associated with a difference in mean COSS slope of change vs. combined (p = 0.4) or placebo-only control (p = 0.05) (trend favoring placebo). 60-day mortality and overall AE/SAE rates were insignificantly higher with losartan.
In this small RCT in hospitalized COVID-19 patients, losartan did not improve outcome and was associated with adverse safety signals.
评估氯沙坦对新冠肺炎患者的疗效和安全性。
COVIDMED是一项双盲、安慰剂对照的平台随机对照试验。参与者被随机分配至标准治疗加羟氯喹、洛匹那韦/利托那韦、氯沙坦或安慰剂组。羟氯喹组和洛匹那韦/利托那韦组提前终止。我们报告氯沙坦组与联合组（洛匹那韦-利托那韦组和安慰剂组）以及预先设定的仅安慰剂对照组的数据。主要终点是新冠肺炎序贯严重程度评分（COSS）变化的平均斜率。入组缓慢导致试验提前终止。
14名患者纳入我们的最终分析（氯沙坦组[N = 9] vs. 对照组[N = 5][洛匹那韦/利托那韦组[N = 2]，安慰剂组[N = 3]]）。大多数基线参数平衡。氯沙坦治疗与联合组（p = 0.4）或仅安慰剂对照组（p = 0.05）相比，在COSS变化平均斜率上无差异（趋势有利于安慰剂）。氯沙坦组60天死亡率和总体不良事件/严重不良事件发生率略高。
在这项针对住院新冠肺炎患者的小型随机对照试验中，氯沙坦未改善预后，且与不良安全信号相关。
