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

项目主任/主要研究者（最后，第一，中间）：奥弗顿，埃德加特纳 摘要： 亚拉巴马CRS密切参与了亚拉巴马COVID-19疫情的应对工作。我们的研究 该团队目前参与了当地应对措施的多个组成部分，包括COVID-19检测， 诊断、流行病学抗体检测以及治疗和预防疗法的开发， COVID-19患者接触者追踪，COVID-19患者的门诊和住院管理，员工 在我们的医护人员中开展预防COVID-19的健康举措，扩大社区检测 （特别是对边缘化群体），在我们机构内部和外部提供教育， 社区，以及领先的研究计划在亚拉巴马州。在我们努力使曲线变平， 为了减轻我们州的COVID-19疾病，我们迫切需要额外的资源，包括额外的人员配备， PCR和抗体检测的额外检测能力，以及完成这项工作的试剂。这 补充为我们的团队提供了实现这些目标所需的资源。 对于这一建议，我们将通过以下项目加强我们正在进行的努力。我们要增加两名护士 实践者对我们的团队。凭借他们的经验水平，他们将在提案的几个方面提供帮助， 包括在社区和研究中扩大测试，识别急性和康复期患者 进行PCR检测和抽血，以促进对病毒动力学的理解，以及 COVID-19患者宿主反应的演变。这些数据、病毒学和血清学样本将提供关键的 深入了解亚拉巴马农村和城市环境中COVID-19的分布和自然历史。 此外，这些数据将有助于更好地了解宿主-病毒相互作用和宿主因素， 有助于疾病的严重性。目前，我们在城市以外进行的测试很少 我们对农村的了解很少。 博士希思与芭芭拉货车德尔波尔博士和她的分子诊断实验室合作， 为我们的机构和亚拉巴马，在整个能力。他们的实验室团队有能力执行一项 每天增加200次PCR检测。我们将利用这一实验室基础设施， 那些无法来到我们城市中心的测试点的人。此外，希思博士的实验室 扩大开发敏感、特异性抗体检测方法的能力，以确定自然史的特征 更重要的是，确定捐献者以挽救生命。这些举措也将 通知在康复期COVID-19患者中寻找保护替代者， 疫苗引发的免疫力，以及单克隆抗体。 OMB编号0925-0001/0002（修订版03/2020批准至02/28/2023）页码继续格式页码

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