Abstract：
This exploratory analysis of the double-blind, phase 3, SCORPIO-SR trial assessed the effect of ensitrelvir in preventing post coronavirus disease 2019 (COVID-19) condition (PCC). Patients with mild-to-moderate COVID-19 were randomized (1:1:1) within 120 h of symptom onset; received 5-day oral ensitrelvir 125 mg (375 mg on day 1), 250 mg (750 mg on day 1), or a matching placebo once daily; and were assessed for the severity of typical PCC symptoms using a self-administered questionnaire. In total, 341, 317, and 333 patients were assessed in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively (mean age, 35.6-36.5 years; men, 53.3%-58.3%). On days 85, 169, and 337, ensitrelvir 125-mg treatment showed 32.7% (95% confidence interval [CI]: -30.6, 66.1), 21.5% (95% CI: -37.3, 55.6), and 24.6% (95% CI: -43.7, 60.9) reductions versus placebo, respectively, in the risk of any of the 14 acute-phase COVID-19 symptoms (at least one mild, moderate, or severe symptom with general health not returning to the usual level). Ensitrelvir 250-mg treatment showed 10.9% (95% CI: -67.0, 52.8), 9.5% (95% CI: -56.6, 48.0), and 30.6% (95% CI: -36.2, 65.5) risk reductions versus placebo on days 85, 169, and 337, respectively. Risk reductions were observed in any of the 4 neurological symptoms and were more pronounced among patients with high acute-phase symptom scores at baseline and among those with a baseline body mass index ≥25 kg/m2. Ensitrelvir treatment in the acute phase of COVID-19 may reduce the risk of various symptoms associated with PCC. TRIAL REGISTRATION NUMBER: jRCT2031210350.
摘要：
这种双盲的探索性分析,3期，SCORPIO-SR试验评估了ensitrelvir预防2019年冠状病毒病（COVID-19）后病情（PCC）的效果。轻度至中度COVID-19患者在症状发作后120小时内被随机分配（1：1：1）；接受5天口服ensitrelvir125mg（第1天375mg），250毫克（第1天750毫克），或匹配的安慰剂每天一次;并使用自编问卷评估典型PCC症状的严重程度。总的来说,341、317和333名患者接受了ensitrelvir125-mg的评估，ensitrelvir250-mg,和安慰剂组，分别(平均年龄，35.6-36.5岁；男性，53.3%-58.3%）。在第85、169和337天，ensitrelvir125-mg治疗显示32.7％（95％置信区间[CI]：-30.6，66.1），21.5%（95%CI：-37.3，55.6），与安慰剂相比，减少了24.6%(95%CI：-43.7，60.9)，分别,在14种急性期COVID-19症状中的任何一种的风险中(至少一种轻度，中度,或严重症状，一般健康状况未恢复到通常水平）。Ensitrelvir250-mg治疗显示10.9%（95%CI：-67.0,52.8），9.5%（95%CI：-56.6，48.0），在第85,169和337天,与安慰剂相比,风险分别降低了30.6%(95%CI:-36.2,65.5).在4种神经系统症状中的任何一种中观察到风险降低，并且在基线时急性期症状评分较高的患者和基线体重指数≥25kg/m2的患者中更为明显。在COVID-19急性期使用Ensitrelvir治疗可能会降低与PCC相关的各种症状的风险。试用登记号：jRCT2031210350。
