Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19 A Randomized Clinical Trial
Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19 A Randomized Clinical Trial
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DOI：
10.1001/jama.2022.2832
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发表时间：
2022-03-14
影响因子：
120.7
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.
老年患者和有合并症的患者感染SARS-CoV-2可能会增加住院和死亡的风险。Sotrovimab是一种中和抗体，用于治疗高危患者，防止COVID-19进展。目的评价索洛维单抗预防轻、中度COVID-19向重症进展的疗效和不良事件。设计、环境和参与者：从2020年8月27日至2021年3月11日，在巴西、加拿大、秘鲁、西班牙和美国的57个地点进行了随机临床试验，包括1057名有症状、轻度至中度COVID-19且至少有1项进展危险因素的非住院患者；随访数据收集至2021年4月8日。干预措施：患者随机（1:1）静脉输注500mg sotrovimab （n = 528）或安慰剂（n = 529）。主要结局和指标：主要结局是在第29天出现COVID-19进展的患者比例（因急性疾病管理或死亡而住院时间持续100 ~ 24小时）；按等级顺序测试了5个次要结局，包括全因急诊就诊、任何时间的急性疾病治疗住院、或第29天死亡，以及进展为需要补充氧气或机械通气的严重或危重呼吸道COVID-19。结果：在预先规定的中期分析中，提前停止入组以评估疗效。在随机分配的1057例患者中（中位年龄为53岁[IQR， 42-62]， 20%为bb0 = 65岁，65%为拉丁裔），sotrovimab组的中位随访时间为103天，安慰剂组的中位随访时间为102天。sotrovimab（6/528[1%]）与安慰剂（30/529[6%]）相比，全因住院时间超过24小时或死亡显著减少(校正相对危险度[RR]， 0.21 [95% CI, 0.09 ~ 0.50]；绝对差异，-4.53%[95% CI, -6.70% ~ -2.37%]
IMPORTANCE Older patients and those with comorbidities who are infected with SARS-CoV-2 may be at increased risk of hospitalization and death. Sotrovimab is a neutralizing antibody for the treatment of high-risk patients to prevent COVID-19 progression.OBJECTIVE To evaluate the efficacy and adverse events of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease.DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial including 1057 nonhospitalized patients with symptomatic, mild to moderate COVID-19 and at least 1 risk factor for progression conducted at 57 sites in Brazil, Canada, Peru, Spain, and the US from August 27, 2020, through March 11, 2021; follow-up data were collected through April 8, 2021.INTERVENTIONS Patients were randomized (1:1) to an intravenous infusion with 500mg of sotrovimab (n = 528) or placebo (n = 529).MAIN OUTCOMES AND MEASURES The primary outcomewas the proportion of patients with COVID-19 progression through day 29 (all-cause hospitalization lasting >24 hours for acute illness management or death); 5 secondary outcomes were tested in hierarchal order, including a composite of all-cause emergency department (ED) visit, hospitalization of any duration for acute illness management, or death through day 29 and progression to severe or critical respiratory COVID-19 requiring supplemental oxygen or mechanical ventilation.RESULTS Enrollment was stopped early for efficacy at the prespecified interim analysis. Among 1057 patients randomized (median age, 53 years [IQR, 42-62], 20% were >= 65 years of age, and 65% Latinx), the median duration of follow-up was 103 days for sotrovimab and 102 days for placebo. All-cause hospitalization lasting longer than 24 hours or death was significantly reduced with sotrovimab (6/528 [1%]) vs placebo (30/529 [6%]) (adjusted relative risk [RR], 0.21 [95% CI, 0.09 to 0.50]; absolute difference, -4.53%[95% CI, -6.70% to -2.37%]; P