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.

抽象的 该补充将支持 ACTIV-2D ACTIV-2D 是评估研究药物治疗以下疾病的安全性和有效性的主方案 该方案是针对患有 SARS-CoV-2 感染的有症状、非住院成人的 III 期多中心研究。 随机、双盲试验，评估 S-217622 治疗症状的安全性和有效性 感染 SARS-CoV-2 的高危非住院成人。 主要结果是确定研究药物 (S-217622) 是否会阻止复合 研究第 29 天因任何原因住院或因任何原因死亡的终点。 住院 定义为在医院或类似的急症护理机构（包括急诊室或 为满足 2019 年严重冠状病毒病患者的医疗需求而设立的临时设施 (COVID-19) 在 COVID-19 大流行期间。