ACTIV-6

摘要 严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 是一种首次出现的新型 β 冠状病毒 2019 年 12 月爆发，此后引发了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，COVID-19 的治疗取得了进展， 多种疫苗已获得紧急使用授权，用于预防 SARS-CoV-2 感染。 然而，疫情仍在继续发展，出现了新的变种，不同地区的感染人数激增。 世界，需要一个持续的证据生成平台，特别是针对 COVID-19 的口服治疗 门诊环境中的感染。为了解决这一未满足的需求，杜克临床研究所、范德比尔特大学 大学医学中心和合作伙伴齐聚一堂，将 ACTIV-6 作为与大师合作的平台 临床试验协议可以作为优先药物重新利用的证据生成系统 具有既定安全记录和临床疗效初步证据的其他适应症 COVID-19 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.