Alabama Clinical Trials Unit - Administrative Supplement: SARS-CoV-2 Testing

Program Director/Principal Investigator (Last, First, Middle): Overton, Edgar Turner Abstract: The Alabama CRS is intimately involved in the response to the Alabama COVID-19 epidemic. Our research team is currently involved in multiple components of the local response, including COVID-19 testing for diagnosis, antibody testing for epidemiology and for the development of therapeutic and preventive therapies, contact tracing of COVID-19 patients, outpatient and inpatient management of COVID-19 patients, employee health initiatives to prevent COVID-19 among our healthcare workers, expanded testing in the community (particularly to marginalized populations), providing education both within our institution and to the outside community, as well as leading research initiatives in the state of Alabama. In our efforts to flatten the curve and mitigate COVID-19 disease in our state, we desperately need additional resources, including additional staffing, additional testing capacity for both PCR and antibody testing, and reagents to complete that work. This supplement provides our team the very resources needed to achieve these aims. For this proposal, we will augment our ongoing efforts with the following projects. We are adding two nurse practitioners to our team. With their level of experience, they will assist with several aspects of the proposal, including expanded testing in community and for research studies, identifying acute and convalescent patients to perform both PCR testing and blood draws to facilitate an understanding of viral kinetics, as well as the evolution of host responses in COVID-19 patients. The data and virologic and serologic samples will provide key insight in to the distribution and natural history of COVID-19 among both rural and urban settings in Alabama. Additionally, these data will inform a greater understanding of the host-viral interaction and host factors that contribute to severity of disease. Currently, we have very little testing being performed outside of the urban centers and have very little understanding of our rural areas. Dr. Heath has partnered with Dr. Barbara Van Der Pol and her molecular diagnostics lab to increase testing capacity for our institution and Alabama, at large. Their laboratory team have the capacity to perform an additional 200 PCR tests per day. We will leverage this laboratory infrastructure to enhance testing for populations that are unable to come to testing sites in our urban centers. In addition, Dr. Heath's lab has expanded capacity to develop sensitive, specific antibody testing approaches to characterize the natural history of disease, and more importantly to identify donors for life-saving plasma donation. These initiatives will also inform the search for surrogates of protection among convalescent COVID-19 patients and the search for vaccine-elicited immunity, as well as monoclonal antibodies. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page Continuation Format Page