What: Two studies whose goals are to prevent infection in those who are exposed to a person with COVID-19 and to prevent need for hospitalization in those who already have the infection, but are not sick enough to be in the hospital.
Why: Effective prevention and treatment of COVID-19 will eliminate severe disease, help patients feel better sooner and reduce viral transmission. Currently, there are no therapies known to achieve this. Transfer of convalescent plasma (CP) from a person who has recovered from infection to others who are at risk for or already have infection may be such a therapy. CP is an established form of therapy and has been used in other epidemics. Additionally, it is a relatively low-cost product that can be produced and sourced locally, which is important for US and global responses to this pandemic.
How: We will perform a randomized controlled study for prevention of infection in 150 people who had a high-risk exposure to someone with COVID-19 and a second randomized control trial for treatment in 1344 people with early infection. In both studies, plasma containing high levels of antibody against SARS-CoV-2 virus will be compared with control plasma that does not contain antibodies to the virus.
Who: This is a highly collaborative multidisciplinary project that is engaging multiple members of the Johns Hopkins community and colleagues across the country in the task of responding to the COVID-19 pandemic. Key team members have included leadership of the Clinical and Translational Science Award (CTSA) Program at Johns Hopkins and nationally, as well national experts in transfusion medicine (Evan Bloch and Aaron Tobian), microbiology (Arturo Casadevall and Andy Pekosz), immunology (Justin Bailey, Andrea Cox) infectious diseases (David Thomas) and critical care/anesthesia.
Where: As the sponsor, JHU is taking the national lead by coordinating other clinical trial centers across the country to run the studies at dozens of locations across the U.S. These include large academic research centers, community-based hospital programs and medical facilities serving American Indians. Selection of those centers focused on their ability to conduct the trial safely, effectively and expeditiously and a is focusing on regions that are being hit hard by COVID-19.