Vanderbilt CTU SARS-CoV-2 Supplement

范德比尔特 CTU SARS-CoV-2 补充品

• 批准号: 10166023
• 负责人: David W Haas
• 金额: $ 55.84万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-02 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166023
• 关键词: 2019-nCoV; Academic Medical Centers; Administrative Supplement; Adult; Antibodies; Antigens; Area; Businesses; COVID-19; COVID-19 pandemic; Caring; Clinical Research; Clinical Trials; Collection; Communicable Diseases; Contact Tracing; Coughing; Coupled; Data; Diagnostic tests; Disease; Disease Outbreaks; Ensure; Environment; Epidemic; Epidemiology; Equipment; Evaluation; Fever; Funding; Funding Opportunities; Future; Grant; HIV; Health Personnel; Healthcare; Healthcare Systems; Hour; Household; Individual; Infection; Infection Control; Location; Malaise; Masks; Measures; Medical Records; Morbidity - disease rate; Nasal turbinate bone structure; National Institute of Allergy and Infectious Disease; Nose; Occupational Health; Participant; Patients; Personal Satisfaction; Play; Population; Prevention; Recommendation; Research; Research Activity; Resistance; Resources; Respiratory Tract Infections; Role; Safety; Schedule; Serologic tests; Seroprevalences; Sexually Transmitted Diseases; Shortness of Breath; Site; Social Distance; Specimen; Sputum; Swab; Symptoms; Syndrome; Tennessee; Testing; Therapeutic; Treatment Efficacy; Tuberculosis; U-Series Cooperative Agreements; United States; United States National Institutes of Health; Universities; Vaccines; Visit; Washington; base; clinical research site; common symptom; experience; follow-up; health care service utilization; mortality; operation; pandemic disease; respiratory; response; sample collection; scale up; screening; success

Project Summary Coronavirus disease 2019 (COVID-19) pandemic caused by Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) required a rapid, coordinated response. The pandemic has interfered with many other important endeavors, including NIH-sponsored non-COVID HIV clinical trials. We need robust plans to implement measures to expand SARS-CoV-2, allowing research units to resume studies being conducted on HIV, while maintaining the safety and well-being of participants and staff. To this end, we have developed strategies relying on a combination of testing for active disease, evaluating seroprevalence, and conducting operations in ways that enforce social distancing and utilization of personal protective equipment (PPE). This project is being implemented at the Vanderbilt Therapeutics Clinical Research Site (VT-CRS), and the Washington University Prevention & Therapeutics (WPT) CRS. This strategy will comprise two aims that involve research participants, their household contacts, and staff: Aim 1) To utilize resources obtained through this administrative supplement to expand SARS-CoV-2 testing within the regions of our Clinical Research Sites; and Aim 2) To utilize resources obtained through this administrative supplement to more quickly and fully resume on-site research activities at our Clinical Research Sites. Among the activities to be implemented are universal testing of study participants for infection by SARS-CoV-2 PCR prior to study visits, either by staff during parking lot drive-through visits or self- collected remotely by study participants. At one CRS, testing will also be offered to adult household contacts of study participants. There will be active screening for symptoms of COVID-19. There will be SARS-CoV-2 antibody testing at the beginning and end of the project period, of staff and/or study participants. This project will substantially expanding SARS-CoV-2 testing, and expedite the opening of our NIAID-funded CRSs. In addition, the experience and information gained during this project will inform future strategies to further expand testing and facilitate clinical trials operations.

项目摘要 2019年冠状病毒病（COVID-19）由严重急性呼吸综合症引起的大流行 2（SARS-COV-2）需要快速，协调的响应。大流行干扰了许多其他重要的 努力，包括NIH赞助的非卵巢HIV临床试验。我们需要强大的计划来实施 扩大SARS-COV-2的措施，使研究单位能够恢复对HIV进行的研究，而 保持参与者和员工的安全和福祉。为此，我们制定了依赖的策略 结合进行活性疾病的测试，评估血清阳性和以方式进行操作 强迫个人防护设备（PPE）的社会疏远和利用。这个项目正在 在Vanderbilt Therapeutics临床研究网站（VT-CRS）和华盛顿大学实施 预防与治疗学（WPT）CRS。该策略将包括两个涉及研究参与者的目标 他们的家庭联系和员工：目标1）利用通过此行政补充获得的资源 在我们的临床研究站点的区域内扩展SARS-COV-2测试；目标2）利用资源 通过这种行政补充获得，以更快，更全面地恢复现场研究活动 我们的临床研究站点。在要实施的活动中包括研究参与者的普遍测试 在学习访问之前，SARS-COV-2 PCR感染，无论是在停车场驾车访问还是自我 由研究参与者远程收集。在一个CRS中，还将对成人家庭接触进行测试 研究参与者。将对COVID-19的症状进行积极筛查。将有SARS-COV-2抗体 在项目开始和结束时，员工和/或学习参与者的测试。这个项目将 大大扩展了SARS-COV-2测试，并加快了我们NIAID资助的CRS的开放。另外， 在此项目中获得的经验和信息将为未来的策略提供信息，以进一步扩大测试和 促进临床试验操作。