UCLA AIDS Prevention and Treatment Clinical Trials Unit

加州大学洛杉矶分校艾滋病预防和治疗临床试验单位

• 批准号: 10166309
• 负责人: Judith S. Currier
• 金额: $ 30万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-03 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166309
• 关键词: 2019-nCoV; Acquired Immunodeficiency Syndrome; Adrenal Cortex Hormones; Antiviral Therapy; Area; COVID-19; Caring; Cessation of life; China; Clinical; Clinical Data; Clinical Treatment; Clinical Trials; Clinical Trials Unit; Development; Disease; Disease Outbreaks; Domiciles; Emergency Situation; Environment; Guidelines; Health; Homelessness; Immunocompromised Host; In Vitro; Incidence; Individual; Infection; Infrastructure; Interferons; International; Link; Lopinavir; Los Angeles; Measures; Methyltransferase; Modeling; Names; Nose; Patients; Peer Review; Peptide Hydrolases; Persons; Plasma; Pneumonia; Polymerase; Population; Press Releases; Prevention; Proteins; Quarantine; Regulation; Reporting; Research; Resources; Ribavirin; Ritonavir; SARS coronavirus; Self Administration; Swab; Testing; Therapeutic; Therapeutic Agents; United States; United States Dept. of Health and Human Services; Viral; Virus; World Health Organization; housing instability; human coronavirus; human disease; innovation; interest; novel; novel therapeutics; pre-clinical; public health emergency; standard of care; targeted treatment

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.

项目摘要 12月在中国武汉出现了以前未知的Betacoronavirus引起的一种新颖的肺炎 2019年。该病毒与严重的急性呼吸综合征冠状病毒（SARS COV-1）密切相关，该病毒 导致2003年爆发，并被评为SARS-COV-2。由SARS-COV-2引起的人类疾病是 称为Covid-19。 在当前的SARS-COV-2爆发期间，已知病例的发病率迅速增加，以至于以至于 2020年1月5日，有59例确认案件，1月20日的2118案件，1月26日，以及 根据各种国际卫生，截至2020年2月25日，超过80,000例和2700例死亡 报告机构。结果，2020年1月30日，《国际卫生法规》紧急情况 世界卫生组织（WHO）委员会宣布Covid-19爆发为公共卫生 紧急国际关注。 2020年1月31日，美国卫生与公共服务部 在美国宣布公共卫生紧急情况。截至2020年3月21日，有297,090例 Covid-19，包括美国（美国）的22,177例案件，全球总共死亡12,755例。 尽管采取了隔离措施，SARS-COV-2仍在继续扩散（1）。爆发预测和建模建议 这些数字将继续上升（2）。 目前，Covid-19还没有特定的抗病毒疗法。很少进行治疗研究 因为大多数人类COV菌株会引起自限性疾病，并且护理是支持的。 SARS-COV-1之后 在2002年至2003年确定，并引起了大量全球爆发，对发展的兴趣增加了 特定的治疗剂。 SARS-COV-1患者用皮质类固醇治疗1型IFN药物， 康复等离子体，利巴韦林和洛匹那韦或利托那韦；除利巴韦林外，其中许多药物具有体外 支持其功效的临床前数据（3-11）。自2002 - 2003年SARS-COV-1爆发以来 靶向病毒入口蛋白，蛋白酶，聚合酶和甲基转移酶的治疗剂已经是 测试；但是，在临床试验中，它们都没有被证明是有效的（12-19）。最近的新闻发布 未审查的信息提出了SARS-COV-2患者子集的潜在功效，但这 仍有待审查和以同行评审的格式进行审查和呈现 有影响力。 鉴于SARS-COV-2感染的特定抗病毒疗法的持续传播和缺乏特异性疗法，该项目将 支持其他测试和研究，以确定具有SARS-COV-2的人，并支持基础架构 在安全和创新的情况下增加测试并进行有关SARS-COV-2治疗剂和预防的研究 环境。