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

项目总结 Insight是开发主方案的主要临床试验网络 治疗性中和单抗(NMAbs)在慢性阻塞性肺疾病住院患者中的应用 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方案，并将在 我们领导的审判。中国证监会对主协议进行了审查，审查结束后， 该方案将提交给FDA。 有许多nMAb需要研究，我们预计将在这项试验中推出不同的治疗方法 接下来的两年。我们预计第一个要研究的nMAb将在#年开始第一次试验 2020年7月。这项赠款补充将用于支持洞察SDMC，4洞察 ICCS。它还将支持与我们的中央标本库(ABML)和一种药物的分包合同 分销公司(PCIPharma)。

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).