Extended follow-up of randomized participants in the INSIGHT START trial

对 INSIGHT START 试验中随机参与者的长期随访

• 批准号: 10198271
• 负责人: James Dennis Neaton
• 金额: $ 451.75万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10198271
• 关键词: 2019-nCoV; AIDS clinical trial group; Biological Specimen Banks; COVID-19; Clinical Treatment; Clinical Trials; Clinical Trials Network; Development; Disease Progression; Enrollment; Grant; Immune response; Infection; Inpatients; Investigation; Lead; Leadership; National Heart, Lung, and Blood Institute; Participant; Patients; Play; Protocols documentation; Randomized; Role; Safety; Therapeutic; Therapeutic Trials; United States Department of Veterans Affairs; Viral; design; drug distribution; follow-up; insight; neutralizing monoclonal antibodies

PROJECT SUMMARY INSIGHT is serving as lead clinical trials network for the development of a master protocol for trials of therapeutic neutralizing monoclonal antibodies (nMAbs) for patients hospitalized with COVID-19. Two NHLBI networks, PETAL and CTSN, the ACTG and Veterans Administration are collaborating with us on the development of the master protocol and will enroll patients in the trial we lead. The master protocol has been reviewed by CSRC and, following that review, the protocol will be submitted to the FDA. There are many nMAbs to study and we anticipate rolling different treatments into this trial over the next 2 years. We anticipate the first nMAb to study will be available to begin the first trial in July 2020. This grant supplement will be used to support the INSIGHT SDMC, 4 INSIGHT ICCs. It will also support subcontracts with our central specimen repository (ABML) and a drug distribution company (PCI Pharma).

项目概要 INSIGHT 是主要临床试验网络，负责开发以下药物的主方案： 对住院患者进行治疗性中和单克隆抗体 (nMAb) 试验 新冠肺炎。两个 NHLBI 网络：PETAL 和 CTSN、ACTG 和退伍军人管理局 正在与我们合作开发主协议并将患者纳入 我们领导的审判。主协议已经中国证监会审核，审核后， 该方案将提交给 FDA。 有许多 nMAb 需要研究，我们预计将不同的治疗方法纳入该试验中 未来2年。我们预计第一个用于研究的 nMAb 将在 2019 年开始首次试验。 2020 年 7 月。这笔补助金将用于支持 INSIGHT SDMC、4 INSIGHT 国际刑事法院。它还将支持与我们的中央样本库 (ABML) 和药物的分包 分销公司（PCI Pharma）。