PPE Request

项目摘要 该应用程序为ACTV-2新冠肺炎临床试验提供个人防护设备，以确保研究的安全进行。 ACTV-2是一种主方案，用于评估用于治疗慢性粒细胞白血病的研究药物的安全性和有效性 有症状的非住院成人感染SARS-CoV-2。它包括第二阶段评估，其中包括 为有前途的代理商无缝过渡到更大的第三阶段评估。 该试验是一个随机的受控平台，允许在治疗过程中添加和删除代理 在相同的试验基础设施内对新药物与安慰剂进行有效测试的研究。当超过 一种新的药物正在同时进行测试，如果可行，将使用相同的安慰剂。 第二阶段评估中的主要结果指标将是症状持续时间，类似于结果 用于门诊流感研究，鼻咽拭子检测SARS-CoV-2RNA，以及安全性。 第二阶段药物是否将在第三阶段继续接受评估的决定将在最后一次评估之后做出 随机服用该制剂或安慰剂的参与者完成了他们第28天的第二阶段访问。如果继续，收集的数据 来自第二阶段登记的参与者将被纳入第三阶段评估。 第三阶段评估是第二阶段试验的继续，适用于符合进一步 评估以及有足够的研究产品可供使用。注册进入第三阶段的代理 将继续进行全功率试验，以确定每种研究药物与安慰剂相比的疗效 预防非住院成人新冠肺炎患者住院和死亡。

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.