Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/

领导和运营中心（LOC）、艾滋病临床试验组（ACTG）；

• 批准号: 10594377
• 负责人: Judith S. Currier
• 金额: $ 7150万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-21 至 2023-05-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10594377
• 关键词: 2019-nCoV; AIDS clinical trial group; Accident and Emergency department; Address; Adult; COVID-19; COVID-19 outbreak; COVID-19 pandemic; Cessation of life; Double-blind trial; Health; Health care facility; Hospitalization; Hospitals; Hour; Immune response; Immunity; Institutes; Investigation; Lead; Leadership; Medical; Phase; Population; Protocols documentation; Randomized; Risk; SARS-CoV-2 infection; Safety; acute care; high risk; operation; prevent; primary outcome; severe COVID-19; symptom treatment

Abstract This supplement will support ACTIV-2D ACTIV-2D is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with SARS-CoV-2 infection. The protocol is a phase III multicenter, randomized, double blind trial to evaluate the safety and efficacy of S-217622 for the treatment of symptomatic high-risk non-hospitalized adults with SARS-CoV-2 infection. The primary outcome is to determine if the investigational agent (S-217622) will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study Day 29. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe coronavirus disease 2019 (COVID-19) during the COVID-19 pandemic.

摘要 本补充资料将支持ACTV-2D Activ-2D是一种主方案，用于评估研究药物治疗慢性粒细胞白血病的安全性和有效性。 有症状的非住院成人感染SARS-CoV-2。该协议是第三阶段多中心， 随机双盲试验评价S-217622治疗对症的安全性和有效性 感染SARS-CoV-2的高危非住院成年人。 主要结果是确定调查剂(S-217622)是否会阻止复合体 研究第29天前因任何原因住院或因任何原因死亡的终点。住院治疗 被定义为在医院或类似的急性护理机构，包括急诊室或≥24小时的急性护理 为满足2019年严重冠状病毒感染者的医疗需求而设立的临时设施 (新冠肺炎)新冠肺炎大流行期间。