SARS-CoV-2中和抗体LY-CoV555与Covid-19门诊病人。

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陈P, Nirula,海勒B, Gottlieb RL, Boscia J,莫里斯J, Huhn G,卡多纳·J, Mocherla B, Stosor V, Shawa我,亚当斯AC, Van Naarden J,卡斯特KL,沈L,杜兰特米,奥克利G, Schade AE, Sabo J, Patel博士,Klekotka P Skovronsky DM

SARS-CoV-2中和抗体LY-CoV555与Covid-19门诊病人。

郑传经地中海J。2020年10月28日。doi: 10.1056 / NEJMoa2029849。

PubMed ID

33113295 (在PubMed

]

文摘

背景:严重急性呼吸系统综合症冠状病毒(SARS-CoV-2)导致冠状病毒疾病2019 (Covid-19),这是最常见的温和但可以严重,危及生命。Virus-neutralizing单克隆抗体预计减少病毒载量,改善症状,并防止住院治疗。方法:在这个正在进行第二阶段试验涉及与最近被诊断为轻度或中度Covid-19门诊,我们随机选取了452名患者接受单一静脉输液的中和抗体LY-CoV555三种剂量(700毫克,2800毫克,或7000毫克)或安慰剂和评估量化病毒学端点和临床结果。主要结果是改变基线的病毒载量在11天。预先计划的中期分析的结果在9月5日,2020年,这里被报道。结果:临时分析时,观察到的意思是减少从基线日志中病毒载量为整个人口为-3.81,为消除超过99.97%的病毒RNA。为病人LY-CoV555 2800毫克剂量的安慰剂的不同基线的减少为-0.53(95%可信区间(CI), -0.98 - -0.08;P = 0.02),病毒载量低3.4倍。较小的差异从基线观察安慰剂的病人中700毫克剂量(-0.20;95%可信区间,-0.66 - 0.25; P = 0.38) or the 7000-mg dose (0.09; 95% CI, -0.37 to 0.55; P = 0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19-related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group. CONCLUSIONS: In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).

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Bamlanivimab