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

病例临床试验单元：行政补充 NOSI AI-20-031。

• 批准号: 10166271
• 负责人: BENIGNO RODRIGUEZ
• 金额: $ 60.12万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166271
• 关键词: 2019-nCoV; AIDS clinical trial group; Address; Administrative Supplement; Advertisements; Antiviral Agents; Archives; Biological; Blood; COVID-19; COVID-19 pandemic; China; Clinical Research; Clinical Research Protocols; Clinical Treatment; Clinical Trials; Clinical Trials Unit; Communities; Country; Diagnosis; Disease; Elements; Enrollment; Ensure; Epidemic; Equipment; Funding; Future; Growth; HIV Vaccine Trials Network; HIV prevention trial; Infection; Infrastructure; Institution; Intervention; Laboratories; Leadership; Materials Testing; Measures; Multi-Institutional Clinical Trial; Observational Study; Organ; Participant; Patient Recruitments; Persons; Phase; Positioning Attribute; Prevention; Prevention Research; Prevention strategy; Prevention trial; Preventive Intervention; Procedures; Process; Public Health; Randomized Clinical Trials; Reporting; Research; Research Design; Research Personnel; Research Support; Risk; Sampling; Secure; Ships; Site; Specimen; Testing; Therapeutic Intervention; Time; Treatment Efficacy; United States; Urine; Vaccines; Virus; effective therapy; efficacy trial; follow-up; immunoregulation; improved; novel coronavirus; novel strategies; outreach; pandemic disease; recruit; research study; response; sample collection; treatment research; treatment strategy; treatment trial; virtual

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.

这种补充应用的主要目的是快速增强两者的能力 案例中的国内CRS临床试验单元，以注册和关注COVID-19的参与者预防 和治疗试验，特别着重于增强站点收集，处理的能力 商店，并在疾病的任何阶段从这些参与者中运送纵向生物学标本 过程。提出了以下具体目标来实现这一目标： 特定目标1：扩大CRS的能力以识别新的SARS-COV-2感染并提供参与 在临床试验和观察研究中。有意义地为预防和 治疗试验将是可以进入最近诊断的SARS-COV-2感染者 被提供参与。在这里，我们将增强两个CRS的能力，以获取这些潜力 通过与中央实验室领导建立伙伴关系并扩大对参与者的支持 可以支持扩展测试并在诊断后尽早提供研究的研究人员。 特定目标2：改善CRS基础设施以促进标本收集和纵向跟随 - 在SARS-COV-2感染的研究参与者中。在重新塑造CRS的挑战中 COVID-19试验是访问安全设施和个人保护设备的限制。解决 这个专用保护的外壳将在CASS CRS中建立，专用的PPE将是 在此资金期间的需要时获得了需要的地方，这将是在 预计哪些供应瓶颈将持续存在。 特定目的3：增强处于风险和SARS-COV-2感染者参与临床研究 协议。招募处于风险和感染的参与者参加Covid-19试验将需要新颖 与社区接触并吸引潜在参与者参与临床研究的策略 尽管没有与CRS的现有连接。为了克服这些障碍，我们将奉献精力 从专门的外展协调员到Covid-19-19招聘，并建立在线广告 旨在最大化入学机会的运动。 特定目的4：提高CRS处理和储存生物规格的能力 19个研究参与者。 COVID-19的处理，存储和存档标本的最终障碍 预防和治疗临床试验需要在加工中增强生物安全预防措施 实验室。在这两个CRS中，都将建立增强的BSL-2工作站，并使用专用设备 在需要时，增加了从COVID-19试验中得出的有效标本的处理能力。