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).

项目总结