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 lowerrespiratory tract infection, progressing in approximately 15-20% of infected persons to severepneumonia 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 isreferred to as Coronavirus Disease 2019 (COVID-19). SARS-CoV-2 infection also manifestswith 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 implicatedin the spread of this highly infectious virus in the community. Efficient, safe, and rigorousresearch and clinical trials are essential to the development of interventions that can treat andprevent COVID-19 infection. The Baltimore-Washington-India Clinical Trials Unit (BWI CTU)supports high quality HIV-related treatment and prevention research at two domestic ClinicalResearch Sites (CRS's) in Baltimore and Washington. The Johns Hopkins University ClinicalResearch Site (JHU CRS) in Baltimore, and the Whitman Walker Health (WWH) CRS inWashington, DC, have highly experienced and innovative leaders in anti-infective research andhave 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 providemedical coverage for more than half of all adult residents in the state. This includes having aphysical presence in every major population center in the state, including the metropolitanWashington, DC, counties -- where nearly half of the state's cases have occurred. This gives usunprecedented access to those with or at risk of this infection. JHU is also home to the Centerfor Immunization Research, a renowned resource for clinical vaccine development andevaluation. We have been invited by the HPTN and HVTN to serve as a site for SARS-CoV-2vaccine and monoclonal antibody prevention trials. COVID-19 clinical research provides specialchallenges beyond the processes developed for most traditional infectious diseases clinicalresearch. This supplement will allow our sites to prepare to offer high quality COVID-relatedclinical research sponsored by DAIDS Networks, and enhance the protection of investigatorsand research participants at JHU and WWH.