ACTIV 6

活性6

基本信息

批准号：
10374695
负责人：
DANIEL K. BENJAMIN
金额：
$ 3849.46万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-17 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10374695
关键词：
2019-nCoV Academic Medical Centers Accident and Emergency department Address Affect Ambulatory Care Benefits and Risks COVID-19 COVID-19 diagnosis COVID-19 pandemic COVID-19 treatment Clinical Clinical Data Clinical Investigator Clinical Research Clinical Trials Clinical trial protocol document Collaborations Data Data Coordinating Center Data Science Data Scientist Early treatment Enrollment Ensure FDA Emergency Use Authorization Generations Geographic Locations Goals Healthcare Systems Hospitals Hybrids Infection Informatics International Leadership Link Methodology Methods Oral Outpatients Participant Patients Pragmatic clinical trial Prevention Principal Investigator Protocols documentation Research Research Institute Research Personnel SARS-CoV-2 infection Safety Site Special Population System United States Vaccination Variant betacoronavirus clinical efficacy cohort data management design drug repurposing experience innovation mortality non-drug novel operation pandemic disease patient engagement response statistics

项目摘要

ABSTRACT Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the oral treatment of COVID-19 infection in the outpatient setting. To address this unmet need the Duke Clinical Research Institute, Vanderbilt University Medical Center and partners are coming together to coordinate ACTIV-6 as a platform with a master clinical trial protocol that can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19.

抽象的严重的急性呼吸综合征冠状病毒2（SARS-COV-2）是一种新型的betacoronavirus，首先出现在2019年12月，此后造成了近一个世纪的全球大流行病例数和总死亡率。在2020年以上，取得了进展，用于治疗Covid-19和几次疫苗已获得紧急使用授权，以预防SARS-COV-2感染。然而，随着新的变种和感染的新变体和不同区域的潮流的发展世界需要一个持续的证据平台，尤其是为了口头待遇在门诊环境中感染。为了解决这个未满足的需求，范德比尔特杜克临床研究所大学医学中心和合作伙伴聚集在一起，将Activ-6作为平台与大师协调临床试验方案可以用作证据生成用于重新使用的优先药物的证据具有既定安全记录和初步证据的其他指示证明了 COVID-19的治疗。