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

本补充申请的主要目的是迅速提高这两种能力， 病例临床试验部门的国内CRS，以招募和跟踪COVID-19预防的参与者 和治疗试验，特别强调加强网站的能力，收集，处理， 在疾病的任何阶段储存和运送这些参与者的纵向生物标本 过程为实现这一目标，提出了以下具体目标： 具体目标1：扩大CRS的能力，以确定新的SARS-CoV-2感染，并提供参与 在临床试验和观察性研究中。有效促进预防和 治疗试验将有机会获得最近确诊的SARS-CoV-2感染者， 提供参与。在这里，我们将加强两个CRS的能力，以利用这些潜力 通过与中心实验室领导层建立伙伴关系并扩大对 研究人员可以支持扩大测试，并在诊断后早期参与研究。 具体目标2：改善CRS基础设施，以促进标本采集和纵向跟踪- 感染SARS-CoV-2的研究参与者。在改造CRS以进行 COVID-19试验限制了获得安全设施和个人防护设备的机会。解决 为此，将在案例CRS处建立专用的防护罩，并将 在本供资期内根据需要进行采购，这将是 预计供应瓶颈将持续存在。 具体目标3：加强高危和SARS-CoV-2感染者参与临床研究 协议.招募高危和受感染的参与者参加COVID-19试验将需要新的 深入社区并吸引潜在参与者参与临床研究的策略 尽管与CRS没有任何联系为了克服这些障碍，我们将致力于 从外展协调员到COVID-19招募，并建立在线广告 最大限度地提高入学机会的活动。 具体目标4：提高CRS处理和储存COVID生物标本的能力- 19名研究人员。处理、储存和存档COVID-19标本的最后障碍 预防和治疗的临床试验是需要加强生物安全防范措施的处理 实验室在两个中央登记系统，将建立配备专用设备的增强型BSL-2工作站 在需要时，提高有效处理COVID-19试验样本的能力。

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.