SARS-CoV-2 testing at the Seattle Vaccine and Prevention CRS (30331)

项目摘要/摘要 2020年3月11日，世界卫生组织宣布，新型冠状病毒的迅速传播， SARS-CoV-2及其相关疾病新冠肺炎已经成为一种全球大流行。持续的危机呼唤 临床研究网站(CRSS)的参与，以快速有效地实现治疗和 控制疫情的预防性措施。我们的CRS，西雅图疫苗试验单位(VTU)，有大量的前科 开展预防性HIV疫苗的观察性队列研究和1-2b期临床试验的经验 以及其他艾滋病毒预防方式。我们建议将这种基础设施和经验带到SARS领域- CoV-2临床研究。我们的建议既是为了扩大CRS的研究活动范围，也是为了让 礼仪行为的新场所。现场CRS活动将包括对恢复的自然历史的研究 新冠肺炎患者，以及早期到晚期疫苗接种方案。将开设和开发新的场馆 为了有效地开展新冠肺炎研究，制定适当的感染预防程序，以预防 SARS-CoV-2传播。这样的新场馆将包括临时结构，将提供 在SARS-CoV-2持续传播的地区进行临床研究，因为特定的暴发地区 在疫情过程中被注意到。

Project Summary/Abstract On March 11, 2020, the World Health Organization declared that the rapid spread of the novel coronavirus, SARS-CoV-2, and its associated disease, COVID-19, had become a global pandemic. The ongoing crisis calls for the involvement of clinical research sites (CRSs) to work rapidly and efficiently toward therapeutic and preventative measures to control the epidemic. Our CRS, the Seattle Vaccine Trials Unit (VTU), has vast prior experience conducting observational cohort studies and phase 1-2b clinical trials of preventative HIV vaccines and other HIV prevention modalities. We propose bringing this infrastructure and experience to the field of SARS- CoV-2 clinical research. Our proposal is both to expand the scope of research activity at our CRS and to involve new venues for protocol conduct. Onsite CRS activity will encompass natural history studies of recovered COVID-19 patients, as well as early to late phase vaccine protocols. New venues will be opened and developed in order to effectively conduct COVID-19 research with appropriate infection prevention procedures to prevent SARS-CoV-2 transmission. Such new venues will include temporary structures that will provide capability to conduct clinical research in areas with continued SARS-CoV-2 transmission as specific areas with outbreaks are noted during the course of the epidemic.