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

项目主任/首席研究员(最后、第一、中间)：埃德加·特纳·奥弗顿 摘要： 阿拉巴马州CRS密切参与了阿拉巴马州新冠肺炎疫情的应对工作。我们的研究 团队目前参与了当地反应的多个组成部分，包括新冠肺炎测试 用于流行病学的诊断、抗体检测以及治疗和预防治疗的发展， 新冠肺炎患者的接触者追踪，新冠肺炎患者的门诊和住院管理，员工 在我们的医护人员中预防新冠肺炎的卫生倡议，扩大了社区检测 (特别是对边缘人群)，在我们机构内部和外部提供教育 社区，以及阿拉巴马州领先的研究倡议。在我们努力使曲线变平的同时 为了减轻我们州的新冠肺炎疾病，我们迫切需要额外的资源，包括额外的人员配备， 用于聚合酶链式反应和抗体检测的额外检测能力，以及完成这项工作的试剂。这 增刊为我们的团队提供了实现这些目标所需的资源。 对于这项提议，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 实践者加入我们的团队。以他们的经验水平，他们将在提案的几个方面提供协助， 包括在社区和研究研究中扩大检测，识别急性和恢复期患者 同时进行聚合酶链式反应检测和抽血，以促进对病毒动力学的了解，以及 新冠肺炎患者宿主反应的演变。数据和病毒学和血清学样本将提供关键 深入了解新冠肺炎在阿拉巴马州农村和城市环境中的分布和自然历史。 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 对疾病的严重程度有影响。目前，我们在城市以外进行的测试非常少 而且对我们的农村地区了解很少。 Heath博士与Barbara Van Der Pol博士和她的分子诊断学实验室合作，增加检测 我们机构和整个阿拉巴马州的能力。他们的实验室团队有能力进行 每天额外进行200次聚合酶链式反应检测。我们将利用此实验室基础设施来增强测试 那些无法来到我们城市中心的考场的人。此外，希思博士的实验室已经 扩大能力，开发敏感、特异的抗体检测方法，以确定自然病史的特征 更重要的是，为拯救生命的血浆捐献确定捐赠者。这些举措还将 通知在康复中的新冠肺炎患者中寻找保护代理并搜索 疫苗诱导的免疫力，以及单抗。 OMB编号0925-0001/0002(批准的第03/2020版至2023年2月28日)续页格式页

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