The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit (BWI CTU)

约翰·霍普金斯大学巴尔的摩-华盛顿-印度临床试验中心 (BWI CTU)

• 批准号: 10165945
• 负责人: Charles W. Flexner
• 金额: $ 46.07万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-25 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10165945
• 关键词: 2019-nCoV; AIDS clinical trial group; Acute; Address; Adult; Adult Respiratory Distress Syndrome; Anti-Infective Agents; Azithromycin; Baltimore; COVID-19; Cessation of life; Clinical; Clinical Research; Clinical Trials; Clinical Trials Support Unit; Clinical Trials Unit; Code; Collaborations; Communicable Diseases; Communities; Community Health Education; Community Outreach; Conduct Clinical Trials; Consent; Coronavirus; Coughing; County; Disease; Education; Elderly; Ensure; Environment; Equipment; Fever; Grant; HIV; HIV Vaccine Trials Network; Health; Health system; High Prevalence; Home environment; Hospitalization; Human Subject Research; Hydroxychloroquine; Immune response; Immunization; India; Infection; Infection Control; Infrastructure; Inpatients; Institution; Laboratories; Lower Respiratory Tract Infection; Medical; Medicine; Monoclonal Antibodies; Outpatients; Participant; Patient Recruitments; Patients; Persons; Pneumonia; Population; Prevention; Prevention Research; Prevention trial; Procedures; Process; Research; Research Personnel; Resources; Risk; Safety; Site; Sore Throat; Support System; Symptoms; Techniques; Testing; Therapeutic; Training; Universities; Vaccines; Viral hepatitis; Virus; Visit; Walkers; Washington; clinical research site; community setting; coronavirus disease; design; experience; flexibility; high risk; implementation research; infection risk; innovation; interest; investigator training; member; metropolitan; outpatient facility; outreach; pandemic disease; pathogen; prevent; recruit; respiratory; therapy development; treatment research; vaccine development; vaccine evaluation

SARS-CoV-2 is a coronavirus that has emerged as a major cause of pandemic upper and lower respiratory tract infection, progressing in approximately 15-20% of infected persons to severe pneumonia that can be complicated by adult respiratory distress syndrome (ARDS) and, in 1- 3% of infected persons, death. Collectively, respiratory and systemic illness due to this virus is referred to as Coronavirus Disease 2019 (COVID-19). SARS-CoV-2 infection also manifests with relatively mild symptoms such as cough, sore throat, and fever, or with no symptoms (asymptomatic infection). Persons with a mild or asymptomatic infection have been implicated in the spread of this highly infectious virus in the community. Efficient, safe, and rigorous research and clinical trials are essential to the development of interventions that can treat and prevent COVID-19 infection. The Baltimore-Washington-India Clinical Trials Unit (BWI CTU) supports high quality HIV-related treatment and prevention research at two domestic Clinical Research Sites (CRS's) in Baltimore and Washington. The Johns Hopkins University Clinical Research Site (JHU CRS) in Baltimore, and the Whitman Walker Health (WWH) CRS in Washington, DC, have highly experienced and innovative leaders in anti-infective research and have a long and successful record of HIV and viral hepatitis clinical research implementation. The health systems that are supported by JHU and our partner institutions currently provide medical coverage for more than half of all adult residents in the state. This includes having a physical presence in every major population center in the state, including the metropolitan Washington, DC, counties -- where nearly half of the state's cases have occurred. This gives us unprecedented access to those with or at risk of this infection. JHU is also home to the Center for Immunization Research, a renowned resource for clinical vaccine development and evaluation. We have been invited by the HPTN and HVTN to serve as a site for SARS-CoV-2 vaccine and monoclonal antibody prevention trials. COVID-19 clinical research provides special challenges beyond the processes developed for most traditional infectious diseases clinical research. This supplement will allow our sites to prepare to offer high quality COVID-related clinical research sponsored by DAIDS Networks, and enhance the protection of investigators and research participants at JHU and WWH.

SARS-COV-2是一种冠状病毒，已成为大流行上层和下部的主要原因 呼吸道感染，大约15-20％的感染者发展为严重 成人呼吸窘迫综合征（ARDS）可能使肺炎复杂化，在1-中 3％的感染者，死亡。由于这种病毒而导致的呼吸和全身性疾病是 被称为2019年冠状病毒病（COVID-19）。 SARS-COV-2感染也表现出来 患有相对轻度的症状，例如咳嗽，喉咙痛和发烧，或没有症状 （无症状感染）。患有轻度或无症状感染的人已涉及 在社区中这种高度感染性病毒的传播中。高效，安全和严格 研究和临床试验对于可以治疗和 预防19号感染。巴尔的摩 - 华盛顿 - 印度临床试验单元（BWI CTU） 支持两个国内临床的高质量HIV相关治疗和预防研究 巴尔的摩和华盛顿的研究地点（CRS）。约翰·霍普金斯大学临床 巴尔的摩的研究网站（JHU CRS）和Whitman Walker Health（WWH）CRS 华盛顿特区，在反感染研究方面拥有经验丰富且创新的领导者 拥有艾滋病毒和病毒肝炎临床研究实施的长期记录。 JHU和我们的合作伙伴机构目前提供的卫生系统目前提供 该州所有成年居民中有一半以上的医疗保险。这包括有一个 包括大都市在内的每个主要人口中心的物理存在 华盛顿特区，县 - 近一半的案件发生了。这给了我们 前所未有的访问那些感染风险或有风险的人。 JHU也是中心的家 用于免疫研究，是一种著名的临床疫苗开发资源 评估。 HPTN和HVTN邀请我们作为SARS-COV-2的站点 疫苗和单克隆抗体预防试验。 COVID-19临床研究提供了特殊 除了针对大多数传统传染病开发的过程之外的挑战临床 研究。这种补充剂将允许我们的网站准备提供高质量相关的相关性 由DAIDS网络赞助的临床研究，并增强了研究人员的保护 以及JHU和WWH的研究参与者。