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.
The COVID-19 pandemic is a rapidly growing unmet medical need that has resulted in the infection of 3.1 million and the death of 132,000 individuals in the United States; yet only two therapies have demonstrated clinical efficacy against this virus to date and only in subsets of patients, thus making it imperative to identify additional treatment options, particularly for hospitalized inpatients whom are at the highest risk of mortality. Anti-SARS- CoV-2 convalescent plasma treatment offers an accessible and practical form of therapy for COVID-19; however, its clinical benefits lack scientific validation. The purpose of this project is to assess the clinical safety and effectiveness of anti-SARS-CoV-2 plasma in inpatient adults affected by COVID-19 via an expeditious and scientifically rigorous placebo-controlled randomized clinical trial.
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