ACTIV-6

摘要 严重急性呼吸综合征冠状病毒2(sars-cov-2)是最早出现的一种新型贝塔冠状病毒。 2019年12月，并自那以来引发了一场近一个世纪以来未曾见过的全球大流行 病例数和总死亡率。2020年来，新冠肺炎的治疗取得了进展， 几种疫苗已获得紧急使用授权，用于预防SARS-CoV-2感染。 然而，随着新的变种和不同地区的感染激增，大流行继续演变。 世界，需要一个持续的证据生成平台，特别是在新冠肺炎的口腔治疗方面 门诊环境中的感染。为了解决这一未得到满足的需求，范德比尔特杜克临床研究所 大学医学中心和合作伙伴走到一起，将Activ-6作为平台与大师进行协调 临床试验方案，可作为优先考虑的药物的证据生成系统 其他有安全记录和初步临床疗效证据的适应症 新冠肺炎的治疗。

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.