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 冠状病毒病2019年(新冠肺炎)由严重急性呼吸系统综合症冠状病毒引起的大流行 2(SARS-CoV-2)需要快速、协调的反应。这场大流行已经干扰了许多其他重要的 努力，包括NIH赞助的非COVID艾滋病毒临床试验。我们需要强有力的计划来实施 扩大SARS-CoV-2的措施，允许研究单位恢复正在进行的关于艾滋病毒的研究，同时 维护参与者和工作人员的安全和福祉。为此，我们制定了依赖于 关于活动性疾病的检测、血清阳性率的评估和手术方式的结合 强制社会距离和个人防护装备(PPE)的使用。这个项目正在进行中 在范德比尔特治疗临床研究网站(VT-CRS)和华盛顿大学实施 预防和治疗(WPT)CRS。这一战略将包括两个涉及研究参与者的目标， 他们的家庭联系人和工作人员：目标1)利用通过本行政补编获得的资源 在我们的临床研究站点范围内扩大SARS-CoV-2检测；以及目标2)利用资源 通过本行政副刊获得，以便更快、更充分地恢复现场研究活动， 我们的临床研究网站。在要实施的活动中，包括对研究参与者进行普遍测试 在研究探访前由工作人员在停车场免下车探访或自助探访时感染SARS-CoV-2 由研究参与者远程收集。在一家CRS，也将向成年家庭接触者提供测试 研究参与者。将对新冠肺炎的症状进行主动筛查。将会有SARS-CoV-2抗体 在项目期开始和结束时对工作人员和/或研究参与者进行测试。这个项目将 大幅扩大SARS-CoV-2测试，并加快开放由NIAID资助的CRSS。此外， 在该项目期间获得的经验和信息将为未来的战略提供参考，以进一步扩大测试和 促进临床试验操作。