Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
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DOI：
10.1056/nejmoa2107934
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发表时间：
2021-10-27
影响因子：
158.5
通讯作者：
Shapiro, Adrienne E.
中科院分区：
文献类型：
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作者：
Gupta, Anil;Gonzalez-Rojas, Yaneicy;Shapiro, Adrienne E.
2019冠状病毒病（Covid-19）不成比例地导致老年患者和有基础疾病的患者住院或死亡。Sotrovimab是一种泛肉瘤病毒单克隆抗体，旨在预防高风险患者在疾病早期的进展。方法在这项正在进行的多中心，双盲，3期试验中，我们随机分配，在1：1比率，非住院的有症状的Covid-19患者在这项预先规定的中期分析中，包括583名患者的意向治疗人群，（sotrovimab组291例，安慰剂组292例），sotrovimab组3例患者（1%），安慰剂组21例患者（7%）发生疾病进展导致住院或死亡（相对风险降低，85%; 97.24%置信区间，44 - 96; P=0.002）。在安慰剂组中，5名患者入住重症监护室，其中1名患者在第29天死亡。在868例患者中评估了安全性（sotrovimab组430例，安慰剂组438例）。sotrovimab组和安慰剂组分别有17%和19%的患者报告了不良事件; sotrovimab组的严重不良事件发生率低于安慰剂组（分别为2%和6%的患者）。结论在轻度至中度Covid-19高风险患者中，sotrovimab降低了疾病进展的风险。未发现安全性信号。
BACKGROUNDCoronavirus disease 2019 (Covid-19) disproportionately results in hospitalization or death in older patients and those with underlying conditions. Sotrovimab is a pan-sarbecovirus monoclonal antibody that was designed to prevent progression of Covid-19 in high-risk patients early in the course of disease.METHODSIn this ongoing, multicenter, double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, nonhospitalized patients with symptomatic Covid-19 (24 hours) for any cause or death within 29 days after randomization.RESULTSIn this prespecified interim analysis, which included an intention-to-treat population of 583 patients (291 in the sotrovimab group and 292 in the placebo group), 3 patients (1%) in the sotrovimab group, as compared with 21 patients (7%) in the placebo group, had disease progression leading to hospitalization or death (relative risk reduction, 85%; 97.24% confidence interval, 44 to 96; P=0.002). In the placebo group, 5 patients were admitted to the intensive care unit, including 1 who died by day 29. Safety was assessed in 868 patients (430 in the sotrovimab group and 438 in the placebo group). Adverse events were reported by 17% of the patients in the sotrovimab group and 19% of those in the placebo group; serious adverse events were less common with sotrovimab than with placebo (in 2% and 6% of the patients, respectively).CONCLUSIONSAmong high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified.