Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients.
Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients.
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DOI：
10.1056/nejmoa2116846
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发表时间：
2022-01-27
期刊：
影响因子：
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通讯作者：
GS-US-540-9012 (PINETREE) Investigators
中科院分区：
文献类型：
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作者：
Gottlieb RL;Vaca CE;Paredes R;Mera J;Webb BJ;Perez G;Oguchi G;Ryan P;Nielsen BU;Brown M;Hidalgo A;Sachdeva Y;Mittal S;Osiyemi O;Skarbinski J;Juneja K;Hyland RH;Osinusi A;Chen S;Camus G;Abdelghany M;Davies S;Behenna-Renton N;Duff F;Marty FM;Katz MJ;Ginde AA;Brown SM;Schiffer JT;Hill JA;GS-US-540-9012 (PINETREE) Investigators
Remdesivir改善了因2019年中重度冠状病毒病（Covid-19）住院患者的临床结局。在有症状的、未住院的、疾病进展风险高的新冠肺炎患者中使用瑞德西韦是否会阻止住院治疗尚不确定。我们进行了一项随机、双盲、安慰剂对照试验，受试者为在过去7天内出现症状且至少有一个疾病进展风险因素（年龄≥60岁、肥胖或某些并存疾病）的非住院COVID-19患者。患者被随机分配接受静脉Remdesivir（第1天200 mg，第2天和第3天100 mg）或安慰剂。主要疗效终点为第28天的COVID-19相关住院或全因死亡的复合终点。主要安全性终点是任何不良事件。次要终点是第28天前COVID-19相关医疗就诊或任何原因死亡的复合终点。共有562名接受随机分组并接受至少一剂remdesivir或安慰剂的患者被纳入分析：remdesivir组279名患者和安慰剂组283名患者。平均年龄为50岁，47.9%的患者为女性，41.8%为西班牙裔或拉丁裔。最常见的并存疾病是糖尿病（61.6%）、肥胖（55.2%）和高血压（47.7%）。Remdesivir组有2名患者（0.7%）发生与COVID-19相关的住院或全因死亡，安慰剂组有15名患者（5.3%）发生与COVID-19相关的住院或全因死亡（风险比，0.13; 95%置信区间[CI]，0.03至0.59; P=0.008）。到第28天，Remdesivir组246名患者中共有4名（1.6%）和安慰剂组252名患者中有21名（8.3%）接受了与Covid-19相关的医疗就诊（风险比，0.19; 95%CI，0.07至0.56）。截至第28天，无患者死亡。Remdesivir组42.3%的患者和安慰剂组46.3%的患者发生不良事件。在新冠肺炎进展高风险的非住院患者中，3天疗程的Remdesivir具有可接受的安全性，住院或死亡风险比安慰剂低87%。（由吉利德科学公司资助; PINETREE ClinicalTrials.gov编号，NCT 04501952; EudraCT编号，2020-003510-12。）
Remdesivir improves clinical outcomes in patients hospitalized with moderate-to-severe coronavirus disease 2019 (Covid-19). Whether the use of remdesivir in symptomatic, nonhospitalized patients with Covid-19 who are at high risk for disease progression prevents hospitalization is uncertain. We conducted a randomized, double-blind, placebo-controlled trial involving nonhospitalized patients with Covid-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions). Patients were randomly assigned to receive intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3) or placebo. The primary efficacy end point was a composite of Covid-19–related hospitalization or death from any cause by day 28. The primary safety end point was any adverse event. A secondary end point was a composite of a Covid-19–related medically attended visit or death from any cause by day 28. A total of 562 patients who underwent randomization and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group. The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx. The most common coexisting conditions were diabetes mellitus (61.6%), obesity (55.2%), and hypertension (47.7%). Covid-19–related hospitalization or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.03 to 0.59; P=0.008). A total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a Covid-19–related medically attended visit by day 28 (hazard ratio, 0.19; 95% CI, 0.07 to 0.56). No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group. Among nonhospitalized patients who were at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo. (Funded by Gilead Sciences; PINETREE ClinicalTrials.gov number, NCT04501952; EudraCT number, 2020-003510-12.)