Clinical Core

临床核心

基本信息

批准号：
10216759
负责人：
Monica Kraft
金额：
$ 56.13万
依托单位：
UNIVERSITY OF ARIZONA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-21 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10216759
关键词：
Administrative Supplement Adult Respiratory Distress Syndrome Allergic inflammation Applications Grants Arizona Aspirate substance Asthma Biological Biological Markers Biology Blood Vessels Brain COVID-19 COVID-19 pandemic Cessation of life Clinical Clinical Course of Disease Clinical Data Cohort Studies Communities Coronavirus Country Data Data Collection Decision Making Disease Disease Progression Edema Enrollment FDA approved Failure Family Functional disorder Gastrointestinal tract structure Goals Grant Heart Heterogeneity Hospitalization Image Immune Immune System Diseases Immune response Immunologics Immunology Immunophenotyping Individual Infection Inflammation Inflammatory Inpatients Institution Intervention Kidney Knowledge Laboratories Liver Lung Middle East Respiratory Syndrome Molecular Profiling Natural Immunity Organ Parents Pathogenesis Pathway interactions Patient Care Patients Peripheral Blood Mononuclear Cell Pharmacotherapy Research Resolution Risk Factors Sampling Serum Severe Acute Respiratory Syndrome Specimen System Test Result Therapeutic Universities Viral Pathogenesis Virus Virus Diseases Whole Blood asthma exacerbation cohort combat cytokine demographics drug development effective therapy endotracheal immunological status improved innate immune mechanisms innovation molecular marker mortality novel novel coronavirus pandemic disease parent grant pathogen precision medicine recruit sample collection screening

项目摘要

PROJECT SUMMARY The Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2)-driven coronavirus disease 2019 (COVID-19) pandemic has fundamentally changed our world, country, community and families. In patients who die of COVID-19, activation of evolutionarily-conserved inflammatory cascades results in massive increases in circulating levels of inflammatory cytokines producing vascular leak, edema of multiple critical organ (lung, kidneys, heart, brain, liver, GI tract), ultimately leading to multi-organ dysfunction including acute respiratory distress syndrome (ARDS). There is lack of deep understanding regarding the risk factors for and biology of COVID-19. The pandemic has also dramatically highlighted the multiple unmet needs in the care for patients with SARS-CoV-2 infection including the lack of validated biomarkers, and of effective FDA-approved pharmacotherapies. Accordingly, this Administrative Supplement seeks to further our understanding through immunophenotyping patients who develop COVID-19. We will provide clinical data and sample collection/processing from a cohort of SARS-CoV-2 patients enrolled in Tucson, Arizona. The clinical data and samples will be transmitted to the central cores that are assigned by the Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC) study with the overarching objectives to better understand the pathogenesis of COVID-19 disease and to identify immunological pathways that can be used to inform us on how to combat this disease. In Specific Aim 1, we will recruit and provide clinical data (demographics, clinical laboratory test results and imaging results, clinical course) longitudinally from patients hospitalized with COVID- 19 infection to the designated IMPACC cores in order to establish correlation with immune status and disease progression. In Specific Aim 2, we will provide biological specimens (serum, whole blood, PBMCs, nasopharyngeal samples, endotracheal aspirates) from patients hospitalized with COVID-19 infection to the designated cores in order to characterize the immunophenotypes and the immune status and response to infection. This supplement supports the University of Arizona's participation in IMPACC to facilitate screening and enrollment of inpatients with COVID-19. The proposed supplement research is within the scope of parent U19 grant entitled “Dysfunction of Innate Immunity in Asthma” (1U19AI125357). In summary, the IMPACC study coordinates a national, multi-institution consortium, collecting detailed clinical data and biologic samples from hospitalized COVID-19 infected individuals, with the goal of identifying immune signatures/molecular biomarkers associated with clinical disease course. These data will allow the prioritization of clinical interventions and therapeutic decision making.

项目概要严重急性呼吸系统综合症相关冠状病毒 2 (SARS-CoV-2) 驱动的 2019 年冠状病毒病（COVID-19）大流行从根本上改变了我们的世界、国家、社区和家庭。随着 COVID-19 的死亡，进化上保守的炎症级联的激活导致炎症细胞因子的循环水平导致血管渗漏、多个关键器官（肺、肾脏、心脏、大脑、肝脏、胃肠道），最终导致多器官功能障碍，包括急性呼吸系统疾病人们对窘迫综合征（ARDS）的危险因素和生物学缺乏深入的了解。 COVID-19 大流行还极大地凸显了患者护理方面的多种未满足的需求。 SARS-CoV-2 感染，包括缺乏经过验证的生物标志物以及 FDA 批准的有效生物标志物因此，本行政补充文件旨在通过药物疗法寻求进一步的理解。我们将提供临床数据和样本，对患有 COVID-19 的患者进行免疫表型分析。收集/处理来自亚利桑那州图森市的一组 SARS-CoV-2 患者的临床数据和样本将被传输到由免疫表型评估指定的中央核心 COVID-19 队列 (IMPACC) 研究的总体目标是更好地了解发病机制 COVID-19 疾病并确定免疫学途径，可用于告诉我们如何在具体目标 1 中，我们将招募并提供临床数据（人口统计、临床数据）。实验室测试结果和影像学结果、临床病程）纵向来自住院的新冠肺炎患者 19 感染指定的 IMPACC 核心，以建立与免疫状态和疾病的相关性在具体目标 2 中，我们将提供生物样本（血清、全血、PBMC、来自住院的 COVID-19 感染患者的鼻咽样本、气管内抽吸物）指定的核心，以表征免疫表型以及免疫状态和反应该补充材料支持亚利桑那大学参与 IMPACC 以促进筛查。拟议的补充研究属于家长的范围。 U19 拨款题为“哮喘先天免疫功能障碍”(1U19AI125357) 总之，IMPACC 研究。协调一个全国性的多机构联盟，收集详细的临床数据和生物样本住院的 COVID-19 感染者，目的是识别免疫特征/分子生物标志物这些数据将有助于确定临床干预措施的优先顺序和治疗决策。