On March 11, 2020, the World Health Organization declared that the rapid spread of the novel coronavirus, SARS-CoV-2, and its associated disease, COVID-19, had become a global pandemic. The ongoing crisis calls for the involvement of clinical research sites (CRSs) to work rapidly and efficiently toward therapeutic and preventative measures to control the epidemic. Our CRS, the Seattle Vaccine Trials Unit (VTU), has vast prior experience conducting observational cohort studies and phase 1-2b clinical trials of preventative HIV vaccines and other HIV prevention modalities. We propose bringing this infrastructure and experience to the field of SARS- CoV-2 clinical research. Our proposal is both to expand the scope of research activity at our CRS and to involve new venues for protocol conduct. Onsite CRS activity will encompass natural history studies of recovered COVID-19 patients, as well as early to late phase vaccine protocols. New venues will be opened and developed in order to effectively conduct COVID-19 research with appropriate infection prevention procedures to prevent SARS-CoV-2 transmission. Such new venues will include temporary structures that will provide capability to conduct clinical research in areas with continued SARS-CoV-2 transmission as specific areas with outbreaks are noted during the course of the epidemic.
The ongoing COVID-19 global health crisis necessitates immediate work toward further understanding the pathogenesis of SARS-CoV-2 infection and development of agents to treat and prevent COVID-19 disease. Our clinical research site will contribute to this effort by expanding our focus from HIV immunology and prevention to the corresponding goals in understanding and preventing SARS-CoV-2 infection and disease. We propose enrolling participants in observational cohorts and in clinical trials of candidate preventive agents, both vaccines and monoclonal antibodies.
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