PPE Request

项目摘要 此应用程序为ACTIV-2 COVID-19临床试验提供PPE，以确保安全进行研究。 ACTIV-2是一项主要方案，用于评价研究药物治疗以下疾病的安全性和有效性： 有症状的非住院成人SARS-CoV-2感染者。它包括第二阶段评价， 无缝过渡到更大规模的III期评估，用于有前途的药物。 该试验是一个随机的，对照的平台，允许在治疗过程中添加和丢弃药物。 在相同的试验基础设施内有效测试新药与安慰剂的研究。当超过 如果同时检测一种新药物，则在可行时将使用相同的安慰剂。 II期评价的主要结局指标是症状持续时间，与结局相似 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。 确定II期药物是否将继续在III期进行评价将在最后一次评估后进行。 随机分配到该药剂或安慰剂组的参与者完成其第28天的II期访视。如果继续，收集的数据 将纳入III期评价。 III期评价是II期试验的延续，对于那些符合进一步研究标准的药物， 评估，并有足够的研究产品可供使用。入组进入III期的药物 将继续进行充分把握度试验，以确定每种试验药物与安慰剂相比的疗效 预防未住院的COVID-19成年患者住院和死亡。

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.