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.

项目总结 严重急性呼吸综合征相关冠状病毒2型(SARS-CoV-2)驱动的冠状病毒病2019 (新冠肺炎)疫情从根本上改变了我们的世界、国家、社区和家庭。在患者中 新冠肺炎死亡，进化保守的炎症级联反应激活导致 炎症细胞因子循环水平导致血管渗漏、多个重要器官(肺、 肾、心、脑、肝、胃肠道)，最终导致包括急性呼吸道在内的多器官功能障碍 窘迫综合征(ARDS)。目前对糖尿病的危险因素和生物学缺乏深入的了解。 新冠肺炎。这场大流行还极大地突显了患者护理方面的多种未得到满足的需求 SARS-CoV-2感染，包括缺乏有效的生物标志物和FDA批准的有效生物标志物 药物疗法。因此，本行政副刊旨在通过以下方式加深我们的理解 患新冠肺炎的患者的免疫表型。我们将提供临床数据和样本 收集/处理来自亚利桑那州图森市登记的SARS-CoV-2患者队列。临床资料和临床资料 样本将被传输到由免疫表型评估分配的中央核心 新冠肺炎队列研究的首要目标是更好地了解发病机制 并找出可用来告知我们如何 与这种疾病作斗争。在具体目标1中，我们将招募并提供临床数据(人口学、临床 实验室检查结果和成像结果，临床病程)纵向来自COVID住院患者- 19感染指定的IMPACC核心，以建立与免疫状态和疾病的相关性 进步。在具体目标2中，我们将提供生物标本(血清、全血、外周血单核细胞、 从新冠肺炎感染住院患者的鼻咽样本、气管内抽吸物)到 指定的核心，以表征免疫表型以及免疫状态和对 感染。本附录支持亚利桑那大学参与IMPACC，以促进筛查 以及新冠肺炎患者的住院人数。建议的补充研究在家长的范围内 U19题为“哮喘的天然免疫功能障碍”的赠款(1U19AI125357)。总而言之，IMPACC的研究 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 住院的新冠肺炎感染者，目标是识别免疫特征/分子生物标志物 与临床病程有关。这些数据将使临床干预和 治疗性决策。