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

SARS-CoV-2是一种冠状病毒，已成为大流行的主要原因 呼吸道感染，大约15%-20%的感染者进展到严重 肺炎可并发成人呼吸窘迫综合征(ARDS)，在1- 3%的感染者死亡。总体而言，这种病毒引起的呼吸道和系统性疾病 称为冠状病毒病2019(新冠肺炎)。SARS-CoV-2感染也表现为 症状较轻，如咳嗽、喉咙痛、发烧或无症状 (无症状感染)。有轻微或无症状感染的人已被牵连 这种高度传染性的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治疗癌症的干预措施至关重要 预防新冠肺炎感染。巴尔的摩-华盛顿-印度临床试验中心(BWI CTU) 支持国内两家临床医院开展高质量的艾滋病毒相关治疗和预防研究 巴尔的摩和华盛顿的研究站点(CRS)。约翰霍普金斯大学临床 巴尔的摩的研究网站(JHU CRS)和惠特曼·沃克健康(WWH)CRS 华盛顿特区在抗感染研究和创新方面拥有丰富的经验和创新的领导者 有长期和成功的艾滋病毒和病毒性肝炎临床研究实施记录。 由JHU和我们的伙伴机构支持的卫生系统目前提供 覆盖该州一半以上的成年居民的医疗保险。这包括拥有一个 在该州的每个主要人口中心都有实体存在，包括大都市 华盛顿特区的县--该州近一半的病例发生在那里。这给了我们 史无前例地接触到感染这种疾病或有感染风险的人。JHU也是该中心的所在地 对于免疫研究，一个著名的临床疫苗开发和 评估。我们已受香港公共卫生署和人类传播网的邀请，作为SARS-CoV-2的现场。 疫苗和单抗预防试验。新冠肺炎临床研究提供特殊 超越为大多数传统传染病临床开发的流程的挑战 研究。这一补充将允许我们的网站准备提供与COVID相关的高质量 DAIDS网络赞助的临床研究，并加强对研究人员的保护 以及JHU和WWH的研究参与者。

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.