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，已成为导致大流行的主要原因， 呼吸道感染，约15-20%的感染者进展为重度 肺炎，可并发成人呼吸窘迫综合征（ARDS），在1- 3%的感染者死亡。总的来说，由这种病毒引起的呼吸道和全身性疾病是 被称为2019冠状病毒病（COVID-19）。SARS-CoV-2感染还表现为 症状较轻，如咳嗽、喉咙痛和发烧，或无症状 （无症状感染者）。轻度或无症状感染者已被牵连 这种高传染性病毒在社区中的传播。高效、安全、严谨 研究和临床试验对于开发能够治疗和 预防COVID-19感染巴尔的摩-华盛顿-印度临床试验单位（BWI CTU） 支持高质量的艾滋病相关治疗和预防研究在国内两个临床 位于巴尔的摩和华盛顿的研究中心（CRS）。约翰霍普金斯大学临床 研究中心（JHU CRS）和惠特曼步行者Health（WWH）CRS 华盛顿，DC，在抗感染研究方面拥有经验丰富和创新的领导者， 有长期成功的HIV和病毒性肝炎临床研究实施记录。 由JHU和我们的合作机构支持的卫生系统目前提供 为该州一半以上的成年居民提供医疗保险。这包括拥有一个 在该州的每一个主要人口中心，包括大都市， 华盛顿特区的县--该州近一半的病例都发生在那里。这给了我们 前所未有地接触到那些感染或有感染风险的人。JHU也是该中心的所在地 免疫研究，一个著名的资源，临床疫苗的发展， 评价我们已被HPTN和HVTN邀请作为SARS-CoV-2的网站 疫苗和单克隆抗体预防试验。COVID-19临床研究提供了特殊的 挑战超出了为大多数传统传染病临床开发的过程 research.该补充将使我们的研究中心能够准备提供高质量的COVID相关 由DAIDS网络赞助的临床研究，并加强对研究者的保护 以及JHU和WWH的研究参与者。