ACTIV-6

摘要 严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是一种新型β冠状病毒， 在2019年12月，从那以后，就造成了近世纪来从未有过的全球大流行， 病例数和总死亡率。2020年，COVID-19的治疗取得了进展， 几种疫苗已获得紧急使用授权，用于预防SARS-CoV-2感染。 然而，这一大流行病继续演变，在世界不同地区出现了新的变种和感染激增。 需要一个持续的证据生成平台，特别是用于COVID-19的口服治疗 门诊感染为了解决这一未满足的需求，范德比尔特的杜克临床研究所 大学医学中心和合作伙伴正在共同协调ACTIV-6作为一个平台， 临床试验方案，可以作为证据生成系统，用于优先药物的重新用途， 具有已确立的安全性记录和临床疗效初步证据的其他适应症 治疗COVID-19。

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.