CoVPN 3501: Eli Lilly (LY3819253) Protocol Funding

摘要： 引起2019年冠状病毒病（COVID-19）的新型病毒SARS-CoV-2是对人类的重大威胁。 公共卫生SARS-CoV-2具有高度传播性，正如目前的大流行所证明的那样， 导致具有临床意义的COVID-19疾病。在严重和危重病例中，SARS-CoV-2感染导致 进行性肺部感染，并发呼吸衰竭，急性呼吸道感染患病率高， 痛苦综合症在所有年龄组中，老年人经历严重COVID-19的风险最大 疾病及其相关并发症（CDC 2020; Grabowski和莫尔2020）。 在全球范围内，有一些关于COVID-19在熟练护理的居民中迅速传播的报告 设施可悲的是，这些疗养院居民也有高相关的发病率和死亡率 （Arons等人，2020; Grabowski和莫尔，2020; Graham等人，2020）。在美国，至少有153，000人 养老院的居民和员工感染了COVID-19疾病，占35%， 国家的死亡人数（Werner et al. 2020）。超过130万美国人住在疗养院（CDC） 2016年，我们迫切需要有效的预防措施。 CoVPN 3501是一项随机、双盲、安慰剂对照、预防性研究，旨在评价 静脉注射mAb LY 3819253预防SARS-CoV-2感染和COVID-19的安全性， 安慰剂预计将随机分配1700-2400例受试者（意向治疗[ITT]人群） 研究干预措施，以便将大约1300名SARS-CoV-2阴性参与者随机分配到 研究的目标是实现约33个事件（在每个小学和关键中学） 端点）。 本研究将评价单克隆抗体（mAb）LY 3819253在 在养老院设施工作人员和居民中预防SARS-CoV-2感染和COVID-19疾病。

Abstract: The novel virus, SARS-CoV-2, which causes Coronavirus Disease – 2019 (COVID-19) is a significant threat to public health. SARS-CoV-2 is both highly transmissible, as is evidenced by the current pandemic, and can lead to clinically significant COVID-19 disease. In severe and critical cases SARS-CoV-2 infection causes progressive pulmonary infection, complicated by respiratory failure, with a high prevalence of acute respiratory distress syndrome. Out of all age groups, older adults have the greatest risk of experiencing severe COVID-19 disease and its associated complications (CDC 2020; Grabowski and Mor 2020). Globally, there are a number of reports of COVID-19 rapidly spreading among the residents of skilled nursing facilities. Sadly, these nursing home residents also have high associated rates of both morbidity and mortality (Arons et al. 2020; Grabowski and Mor 2020; Graham et al. 2020). In the United States (US), at least 153,000 nursing home residents and employees have contracted COVID-19 disease and account for 35% of the country’s deaths (Werner et al. 2020). With more than 1.3 million Americans living in nursing homes (CDC 2016), there is an urgent need for effective, preventative strategies. CoVPN 3501 is a randomized, double-blind, placebo-controlled, prophylaxis study to evaluate the efficacy and safety of the intravenous mAb, LY3819253, in preventing SARS-CoV-2 infection and COVID-19, compared to placebo. It is expected that 1700-2400 participants (intent-to-treat [ITT] population) will be randomly assigned to study intervention such that approximately 1300 SARS-CoV-2 negative participants are randomized in the study with the goal of achieving approximately 33 events (in each of the primary and key secondary endpoints). This study will evaluate the effectiveness and safety of a monoclonal antibody (mAb), LY3819253, in preventing SARS-CoV-2 infection and COVID-19 disease in nursing home facility staff and residents.