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，已成为全球大流行的主要原因