Passive Immunity Trial for Our Neighbors (PassITON): A randomized, placebo-controlled multi-site trial of anti-SARS-CoV-2 convalescent plasma to treat hospitalized adults with COVID-19

为我们的邻居进行的被动免疫试验 (PassITON)：一项随机、安慰剂对照的多中心抗 SARS-CoV-2 恢复期血浆试验，用于治疗患有 COVID-19 的住院成人

• 批准号: 10218949
• 负责人: Gordon R Bernard
• 金额: $ 3400万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10218949
• 关键词: 2019-nCoV; Adult; Affect; Agreement; COVID-19; COVID-19 pandemic; Cessation of life; Clinical; Clinical Research; Clinical Trials Design; Collaborations; Communities; Data; Data Collection; Effectiveness; Ensure; Health Sciences; Individual; Infection; Informatics; Inpatients; Institutes; Institution; Knowledge; Legal; Measurable; Medical; Methodology; Methods; Mission; Multi-Institutional Clinical Trial; Passive Immunity; Placebos; Plasma; Randomized; Readiness; Research; Research Infrastructure; Resources; Safety; Science; Translational Research; Translations; United States; Validation; Virus; clinical efficacy; drug development; high risk; improved; mortality risk; multi-site trial; novel; patient subsets; pragmatic trial; programs; randomized placebo-controlled clinical trial; recruit; service programs; skills; translational study

The Vanderbilt Institute for Clinical and Translational Research (VICTR) is a highly functional and integrated clinical and translational (C&T) research infrastructure that has raised the quality and scientific rigor of the research conducted at Vanderbilt and longstanding partner Meharry, the nation's oldest historically black academic health science institution. VICTR will contribute to the mission of the CTSA program while leveraging unique resources and expertise within VICTR's Hub with these aims: 1) Leverage VICTR's strong collaborative energy to enhance team science methodologies that propel transdisciplinary research approaches, and integrate proven community engagement principles to stakeholders for all stages of research; 2) Develop, implement and disseminate informatics and data organization methods to promulgate research efficiency, quality, and preparedness and integrate data collection in the conduct of pragmatic trials; 3) Ensure the translational science workforce is diverse and has the skills, knowledge, and resources necessary to advance translation of discoveries; 4) Measurably improve the efficiency, quality, and representativeness of C&T studies by enhancing and systematically integrating services and programs that support highest quality research initiation and conduct; 5) Measurably improve the efficiency and quality of multi-site clinical trials, in collaboration with the TICs and RICs, by leveraging centralized regulatory and legal agreements, providing rapid feasibility and recruitment methods and practices, and creating and disseminating novel clinical trial designs and methodologies; and 6) Utilize unique strengths leveraging novel resources BioVU and PheWAS to guide drug development and repurposing.

范德比尔特临床和转化研究所（VICTR）是一个高度功能的 以及综合临床和转化（C＆T）研究基础设施，提高了质量 以及在范德比尔特（Vanderbilt）和长期合作伙伴梅哈里（Meharry）进行的研究的科学严谨性， 美国最古老的黑人学术健康科学机构。 Victr将为 CTSA计划的任务同时利用独特的资源和专业知识 Victr的枢纽以这些目的：1）利用Victr的强大协作能量来增强 推动跨学科研究方法并整合的团队科学方法论 验证的社区参与原则向利益相关者的所有研究阶段； 2）发展， 实施并传播信息学和数据组织方法来颁布研究 效率，质量和准备性，并整合务实的数据收集 试验； 3）确保转化科学员工多样化，并具有技能，知识， 以及推进发现翻译所需的资源； 4）可测量地改善 C＆T研究的效率，质量和代表性，通过增强和系统地增强 集成支持最高质量研究启动和行为的服务和计划； 5）与合作 通过利用集中的监管和法律协议，抽动和RICS提供了快速 可行性和招聘方法和实践，并创建和传播新型临床 试验设计和方法论； 6）利用独特的优势利用新的资源 Biovu和Phewas指导药物开发和重新利用。