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

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.