Clinical Core

临床核心

• 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
• 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

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.

项目摘要 2019年严重急性呼吸综合征相关冠状病毒2（SARS-CoV-2）驱动的冠状病毒疾病 2019冠状病毒病疫情从根本上改变了我们的世界、国家、社区和家庭。的患者 死于COVID-19，激活进化保守的炎症级联反应导致 炎性细胞因子的循环水平产生血管渗漏，多个关键器官（肺， 肾、心脏、脑、肝、胃肠道），最终导致多器官功能障碍，包括急性呼吸道疾病， 窘迫综合征（ARDS）。目前，人们对糖尿病的风险因素和生物学缺乏深入的了解。 2019冠状病毒病。这一流行病还突出表明，在照顾病人方面存在着多种未得到满足的需求 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 药物治疗因此，本行政补充材料旨在通过以下方式加深我们的理解： 对新冠肺炎患者进行免疫分型。我们将提供临床数据和样本 从亚利桑那州图森市登记的SARS-CoV-2患者队列中收集/处理。的临床资料及 样本将被传送到免疫表型评估分配的中心核心， COVID-19队列（IMPACC）研究，总体目标是更好地了解发病机制 并确定免疫途径，可用于告知我们如何 对抗这种疾病。在具体目标1中，我们将招募并提供临床数据（人口统计学、临床 实验室检查结果和影像学结果、临床病程）， 19感染指定的IMPACC核心，以建立与免疫状态和疾病的相关性 进展在具体目标2中，我们将提供生物样本（血清、全血、PBMC、 鼻咽样本，气管内抽吸物），从COVID-19感染住院患者到 指定的核心，以表征免疫表型和免疫状态， 感染该补充材料支持亚利桑那大学参与IMPAC，以促进筛查 以及新冠肺炎住院患者的登记。建议的补充研究在母公司范围内 U19资助，题为“哮喘中先天免疫功能障碍”（1U 19 AI 125357）。总之，IMPAC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 与临床病程相关。这些数据将有助于确定临床干预措施的优先次序， 治疗决策