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）是一个功能强大的 以及集成的临床和转化（C&T）研究基础设施，提高了质量 范德比尔特和长期合作伙伴梅哈里进行的研究的科学严谨性， 美国历史上最古老的黑人健康科学学术机构。卢旺达问题国际法庭将协助 CTSA计划的使命，同时利用内部的独特资源和专业知识， 1）利用卢旺达问题国际法庭强大的协作能力， 团队科学方法，推动跨学科的研究方法， 在研究的所有阶段，向利益相关者提供经过验证的社区参与原则; 2）制定， 实施和传播信息学和数据组织方法， 效率、质量和准备，并将数据收集纳入务实的 试验; 3）确保转化科学的劳动力是多样化的，并具有技能，知识， 和必要的资源，以促进发现的翻译; 4）可衡量地提高 效率，质量和C&T研究的代表性，通过加强和系统 整合支持最高质量研究启动和开展的服务和计划; 5)可衡量地提高多中心临床试验的效率和质量，与 TIC和RIC通过利用集中的监管和法律的协议， 可行性和招聘方法和做法，并创造和传播新的临床 试验设计和方法;以及6）利用独特优势，利用新资源 BioVU和PheWAS指导药物开发和再利用。