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Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial 期刊论文

编号：

8C41A0F922063CA91F9F59DC58B02B21
作者：

Luetkemeyer, Anne F.^[1] Chew, Kara W.^[2] Lacey, Stuart^[3] Hughes, Michael D.^[4] Harrison, Linda J.^[4] Daar, Eric S.^[5] Eron, Joseph^[6] Fletcher, Courtney V.^[7] Greninger, Alexander L.^[8] Hessinger, Diane^[9] Li, Jonathan Z.^[10] Mailhot, David^[9] Wohl, David^[6] Chayakulkeeree, Methee^[11] Accini Mendoza, Jose Luis^[12] Elistratova, Polina^[13] Makinde, Oluwaseun^[13] Morgan, Gareth^[14] Portsmouth, Simon^[13] Uehara, Takeki^[15] Smith, Davey^[16] Currier, Judith S.^[2]
语种：

英文
期刊：

CLINICAL INFECTIOUS DISEASES ISSN：1058-4838 2025 年 ; 2025 FEB 17
疾病分类：

新型冠状病毒肺炎
关键词：

COVID-19 ensitrelvir high risk symptom resolution viral rebound
摘要：

Background. Ensitrelvir, a severe acute respiratory syndrome coronavirus-2 main protease inhibitor, has demonstrated clinical and virologic efficacy in previous studies. Methods. In this global phase 3 trial, nonhospitalized adults with mild-to-moderate coronavirus disease 2019 (COVID-19) and symptom onset within 5 days were randomized (1:1) to receive once-daily ensitrelvir (375 mg day 1, 125 mg days 2-5) or blinded matching placebo. The primary endpoint was the restricted mean time to sustained (>= 2 days) resolution of 15 COVID-19 symptoms, recorded in participant daily diaries, through day 29 in participants starting treatment within 3 days after symptom onset. Virologic efficacy and safety were assessed. Results. Of 2093 participants, 1888 started treatment within 3 days after symptom onset. Mean time to symptom resolution was 12.5 and 13.1 days with ensitrelvir and placebo, respectively (difference, -0.6 days; 95% confidence interval, -1.38 to 0.19; P = .14). On day 4, ensitrelvir reduced least-squares mean RNA by 0.72 log10 copies/mL more than placebo (95% confidence interval, 0.55-0.90). Among those with positive viral cultures at enrollment, 274/287 (95.5%) ensitrelvir-treated versus 210/280 (75.0%) placebo-treated participants had negative cultures on day 4. RNA rebound was similar (<1.5%) between groups. The proportion of participants with >= 1 adverse event was similar with ensitrelvir (61.5%) and placebo (60.6%). No treatment-related serious adverse events or deaths occurred. Three (0.3%) ensitrelvir-treated and 1 (0.1%) placebo-treated participants had COVID-19-related hospitalizations by day 29. Conclusions. Despite the evidence of antiviral activity with ensitrelvir, this trial did not demonstrate a significant difference in time to sustained symptom resolution.
推荐引用方式
GB/T 7714：

Luetkemeyer Anne F.,Chew Kara W.,Lacey Stuart, et al. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial [J].CLINICAL INFECTIOUS DISEASES,2025.
APA：

Luetkemeyer Anne F.,Chew Kara W.,Lacey Stuart,Hughes Michael D.,&Currier Judith S..(2025).Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial .CLINICAL INFECTIOUS DISEASES.
MLA：

Luetkemeyer Anne F., et al. "Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial" .CLINICAL INFECTIOUS DISEASES(2025).
数据来源自科睿唯安Web of Science核心合集
入库时间：

2025/3/11 16:02:12
更新时间：

2025/3/11 16:02:12

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