UCLA AIDS Prevention and Treatment Clinical Trials Unit

项目摘要 去年12月，一种此前不为人知的贝塔冠状病毒引起的新型肺炎出现在武汉中国 2019年。该病毒与严重急性呼吸综合征冠状病毒(SARS CoV-1)密切相关，后者 导致2003年爆发，并已被命名为SARS-CoV-2。由SARS-CoV-2引起的人类疾病是 叫做新冠肺炎。 在目前的SARS-CoV-2疫情期间，已知病例的发病率迅速增加，以至于在 2020年1月5日确诊59例，1月20日278例，1月26日2118例， 根据各种国际卫生组织的数据，截至2020年2月25日，超过8万例病例和2700例死亡 报告机构。因此，在2020年1月30日，《国际卫生条例》紧急情况 世界卫生组织(世卫组织)委员会宣布新冠肺炎疫情为公共卫生 国际关注的紧急情况。2020年1月31日，美国卫生与公众服务部 宣布美国进入公共卫生紧急状态。截至2020年3月21日，共有297,090例 新冠肺炎，包括美国的22,177例，导致全球总计12,755人死亡。 尽管采取了隔离措施，SARS-CoV-2仍在继续传播(1)。疫情预测和建模表明 这些数字将继续上升(2)。 目前，还没有针对新冠肺炎的特效抗病毒疗法。几乎没有进行过治疗研究。 因为大多数人类冠状病毒毒株都会导致自限性疾病，而护理是支持性的。在SARS-CoV-1之后 在2002-2003年被发现并引起全球大规模疫情后，人们对这一发展越来越感兴趣 特定的治疗剂。SARS-CoV-1患者接受皮质类固醇、1型干扰素药物、 恢复期血浆、利巴韦林、洛比那韦或利托那韦；除利巴韦林外，许多这些药物在体外都有 支持其疗效的临床前数据(3-11)。自2002-2003年SARS-CoV-1爆发以来，新的 针对病毒进入蛋白、蛋白酶、聚合酶和甲基转移酶的治疗药物已经被 经过测试；然而，在临床试验中，没有一种药物被证明是有效的(12-19)。最近发布的新闻稿 而非同行评审的信息表明，对SARS-CoV-2患者的部分患者具有潜在的疗效，但这 仍需以同行评审的格式进行审查并提交，并具有足够的粒度以用于临床 很有影响力。 鉴于SARS-CoV-2感染的持续传播和缺乏特定的抗病毒治疗，该项目将 支持更多的测试和研究以确定感染SARS-CoV-2的人，并支持基础设施以 安全创新地加大对SARS-CoV-2治疗和预防的检测和研究 环境。

Project Summary A novel pneumonia caused by a previously unknown betacoronavirus emerged in Wuhan, China, in December 2019. The virus is closely related to the severe acute respiratory syndrome coronavirus (SARS CoV-1), which led to an outbreak in 2003, and has been named SARS-CoV-2. The human disease caused by SARS-CoV-2 is called COVID-19. During the current SARS-CoV-2 outbreak, the incidence of known cases has rapidly increased such that, on January 5, 2020, there were 59 confirmed cases, 278 cases on January 20, 2118 cases on January 26, and more than 80,000 cases and 2700 deaths as of February 25, 2020, according to various international health reporting agencies. As a result, on January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the COVID-19 outbreak a Public Health Emergency of International Concern. On January 31, 2020, the US Department of Health and Human Services declared a public health emergency in the United States. As of March 21, 2020, there are 297,090 cases of COVID-19, including 22,177 cases in the United States (US), resulting in a total of 12,755 deaths globally. Despite quarantine measures, SARS-CoV-2 continues to spread (1). Outbreak forecasting and modeling suggest that these numbers will continue to rise (2). At present, there is no specific antiviral therapy for COVID-19. Few treatment studies have been conducted because most human CoV strains cause self-limited disease, and care is supportive. After SARS-CoV-1 was identified in 2002-2003 and caused a large global outbreak, there was an increased interest in the development of specific therapeutic agents. SARS-CoV-1 patients were treated with corticosteroids, type 1 IFN agents, convalescent plasma, ribavirin, and lopinavir or ritonavir; except for ribavirin, many of these agents have in vitro pre-clinical data that support their efficacy (3-11). Since the SARS-CoV-1 outbreak in 2002-2003, new therapeutic agents targeting viral entry proteins, proteases, polymerases, and methyltransferases have been tested; however, none of them has been shown to be efficacious in clinical trials (12-19). Recent press-release and non-peer reviewed information suggests potential efficacy for a subset of SARS-CoV-2 patients, but this remains to be reviewed and presented in peer-reviewed formats with sufficient granularity to be clinically impactful. Given the continued spread of and lack of specific antiviral therapy for SARS-CoV-2 infection, this project will support additional testing and research to identify persons with SARS-CoV-2, and support infrastructure to increase testing and conduct research on SARS-CoV-2 therapeutics and prevention in a safe and innovative environment.