Initial recruitment approaches for the COVE study
INFECTIOUS DISEASES, RECRUITMENT, ALLERGY
The initial enrollment strategy for the COVE study was designed with input from Moderna, Inc., Operation Warp Speed leadership, and the COVID-19 Prevention Network (CoVPN), the latter of which was formed by the National Institute of Allergy and Infectious Diseases (NIAID) to develop and conduct COVID-19 vaccine and monoclonal antibody phase 3 studies. Further, in accordance with guidance from the FDA (Participants were enrolled from a broad geographic distribution of 99 research study sites in 31 states across the United States, with site selection based on the site’s feasibility to conduct the study, locally high incidence of COVID-19 based on epidemiologic data and predictive modeling, and site proximity to places of high occupational risk (e.g., factory and construction workers or grocers). Study sites were also selected based on each site’s queried ability to enroll diverse and at-risk populations, and discussions with sites indicated their overall awareness and understanding of the importance of this task.The initial enrollment strategy also took into consideration the longstanding barriers to enrollment of Black and Hispanic participants in US clinical trials, with industry and community experts brought in to review the strategy and to monitor enrollment progress. Initially, sites were asked to develop a local enrollment strategy that supported and planned community outreach tactics for their unique location (Initial enrollment strategy of the COVE study and the need for an evolving recruitment approach to achieve equitable representation in study populations. 