Case Clinical Trials Unit: Administrative Supplement NOSI AI-20-031.

此补充应用程序的主要目标是快速增强两者的能力 病例临床试验单位国内CRSS招募和跟踪新冠肺炎预防参与者 和治疗试验，特别强调加强场地的收集、处理、 在疾病的任何阶段存储、运输来自这些参与者的纵向生物标本 进程。为实现这一目标，提出了以下具体目标： 具体目标1：扩大疾病控制与预防中心的能力，以发现新的SARS-CoV-2感染病例并提供参与 在临床试验和观察性研究中。对预防和预防作出有意义贡献的关键要素 治疗试验将可以接触到最近诊断为SARS-CoV-2感染的人，他们可以 被允许参与。在这里，我们将加强两个社区服务中心的能力，以利用这些潜力 通过与中央实验室领导层建立合作伙伴关系并扩大对 能够支持扩展测试并在诊断后及早参与研究的研究人员。 具体目标2：改善CRS基础设施，以便利标本收集和纵向跟踪-- 感染SARS-CoV-2的研究对象的UP。在重新调整CRSS以进行 新冠肺炎试用是对使用安全设施和个人防护装备的限制。致信地址 在Case CRS将建立专用保护外壳，并将设置专用个人防护设备 在本供资期间需要时购置，这将是期间的关键间隔 这些供应瓶颈预计将持续存在。 具体目标3：加强高危人群和SARS-CoV-2感染者对临床研究的参与 协议。新冠肺炎试验招募高危和感染参与者将需要新颖的 接触社区的策略，并让潜在参与者参与临床研究 尽管目前没有与CRSS的连接。为了克服这些障碍，我们将全力以赴 从外展协调员专门到新冠肺炎招聘，并建立网络广告 最大限度地扩大招生机会的活动。 具体目标4：提高CRS处理和存储来自COVID的生物标本的能力 19名研究对象。处理、存储和归档新冠肺炎标本的最后障碍 预防和治疗临床试验需要在过程中加强生物安全预防措施 实验室。在两个研究站，将建立增强型BSL-2工作站，配备专用设备 需要时，提高高效处理来自新冠肺炎试验的标本的能力。

The primary objective of this supplemental application is to rapidly enhance the ability of the two domestic CRSs in the Case Clinical Trials Unit to enroll and follow participants in COVID-19 prevention and treatment trials, with a particular emphasis on enhancing the sites’ capacity to collect, process, store, and ship longitudinal biological specimens from these participants at any stage of the disease process. The following specific aims are proposed to accomplish this objective: Specific aim 1: To expand CRS capacity to identify new SARS-CoV-2 infections and to offer participation in clinical trials and observational studies. A key element to contribute meaningfully to prevention and treatment trials will be to have access to recently diagnosed persons with SARS-CoV-2 infection who can be offered participation. Here, we will enhance the capacity of the two CRSs to access these potential participants by establishing partnerships with central laboratory leadership and expanding support for research staff who can support expanded testing and offer participation in research early after diagnosis. Specific aim 2: To improve CRS infrastructure to facilitate specimen collection and longitudinal follow- up of SARS-CoV-2 infected study participants. Among the challenges to refashion the CRSs to conduct COVID-19 trials are limitations in access to secure facilities and personal protection equipment. To address this, dedicated protective enclosures will be established at the Case CRS, and dedicated PPE will be acquired where needed for the duration of this funding period, which will be the critical interval during which supply bottlenecks are anticipated to persist. Specific aim 3: To enhance participation of at-risk and SARS-CoV-2-infected persons in clinical research protocols. Recruitment of at-risk and infected participants into COVID-19 trials will require novel strategies to reach out into the community, and to engage potential participants into clinical research despite no existing connection to the CRSs. To overcome these obstacles, we will devote dedicated effort from outreach coordinators specifically to COVID-19 recruitment, and establish online advertisement campaigns to maximize opportunities for enrollment. Specific aim 4: To increase CRS capacity for processing and storage of biological specimens from COVID- 19 research participants. The final barrier to processing, storing, and archiving specimens from COVID-19 prevention and treatment clinical trials is the need for enhanced biosafety precautions in the processing laboratory. At both CRSs, enhanced BSL-2 workstations will be established, with dedicated equipment when needed, to increase the ability to process efficiently specimens derived from COVID-19 trials.