PPE Request

个人防护装备要求

• 批准号: 10293979
• 负责人: Judith S. Currier
• 金额: $ 93.54万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-24 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10293979
• 关键词: Adult; COVID-19; COVID-19 detection; Cessation of life; Clinical Trials; Data; Drops; Enrollment; Ensure; Evaluation; Hospitalization; Influenza; Infrastructure; Investigation; New Agents; Outcome; Outcome Measure; Outpatients; Participant; Phase; Placebos; Protocols documentation; RNA; Randomized; SARS-CoV-2 infection; Safety; Symptoms; Testing; Visit; nasopharyngeal swab; phase 2 testing; phase 3 testing; phase II trial; prevent; primary outcome; symptom treatment

Project Summary This application provides PPE for the ACTIV-2 COVID-19 clinical trial to ensure safe study conduct. ACTIV-2 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. It includes a Phase II evaluation, with a seamless transition into a larger Phase III evaluation for promising agents. The trial is a randomized, controlled platform that allows agents to be added and dropped during the course of the study for efficient testing of new agents against placebo within the same trial infrastructure. When more than one new agent is being tested concurrently, the same placebo will be used, when feasible. The primary outcome measures in the Phase II evaluation will be duration of symptoms, similar to the outcome used for outpatient influenza studies, detection of SARS-CoV-2 RNA by nasopharyngeal (NP) swab, and safety. Determination of whether a Phase II agent will continue to be evaluation in Phase III will be made after the last participant randomized to that agent or placebo completes their day 28 Phase II visit. If continued, data collected from participants enrolled in Phase II will be included in the Phase III evaluation. The Phase III evaluation is a continuation of the Phase II trial, for those agents that meet criteria for further evaluation and for which sufficient study product is available. Enrollment of those agents advancing to Phase III will continue for a fully powered trial to determine the efficacy of each investigational agent compared to placebo to prevent hospitalization and death in non-hospitalized adults with COVID-19.

项目概要 该应用程序为 ACTIV-2 COVID-19 临床试验提供个人防护装备，以确保研究的安全进行。 ACTIV-2 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 有症状、非住院的 SARS-CoV-2 感染成人。它包括第二阶段评估， 对有前途的药物无缝过渡到更大规模的 III 期评估。 该试验是一个随机、受控的平台，允许在试验过程中添加和删除药物。 该研究旨在在同一试验基础设施内有效测试新药与安慰剂的对比。当超过 正在同时测试一种新药物，如果可行，将使用相同的安慰剂。 第二阶段评估的主要结果指标将是症状的持续时间，类似于结果 用于门诊流感研究、通过鼻咽 (NP) 拭子检测 SARS-CoV-2 RNA 以及安全性。 将在最后一次评估后确定是否继续在第三阶段评估第二阶段药物 随机接受该药物或安慰剂的参与者完成第 28 天的 II 期访视。如果继续，收集的数据 参加第二阶段的参与者将被纳入第三阶段的评估中。 III 期评估是 II 期试验的延续，对于那些符合进一步标准的药物 评估并且有足够的研究产品可用。进入 III 期的药物的注册 将继续进行全面试验，以确定每种研究药物与安慰剂相比的功效 防止患有 COVID-19 的非住院成人住院和死亡。