SARS-CoV-2 testing at the Seattle Vaccine and Prevention CRS (30331)

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Project Summary/Abstract 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.