IMPACC convalescent data collection, including Patient Reported Outcomes (PROs) and home visit sampling

IMPACC 恢复期数据收集，包括患者报告结果 (PRO) 和家访抽样

• 批准号: 10290547
• 负责人: OFER LEVY
• 金额: $ 212.99万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-25 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10290547
• 关键词: 2019-nCoV; Architecture; Award; Bioinformatics; Biological; Biological Markers; Blood specimen; COVID-19; COVID-19 patient; Case Report Form; China; Clinical; Clinical Data; Clinical Trials; Cohort Studies; Collection; Controlled Clinical Trials; Coughing; Critical Care; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Storage and Retrieval; Diagnostic radiologic examination; Disease; Disease Progression; Enrollment; Ensure; Fever; Genomics; Goals; Home visitation; Hospitalization; Hospitals; Immune response; Immunologics; Immunophenotyping; Infection; Infrastructure; Integration Host Factors; Intervention; Investigation; Kinetics; Label; Laboratories; Lung diseases; Malaise; Measures; Modeling; Monitor; Morbidity - disease rate; Myalgia; National Institute of Allergy and Infectious Disease; Neonatal; Newborn Infant; Nose; Onset of illness; Parents; Patient Outcomes Assessments; Patients; Phenotype; Predisposition; Process; Quality Control; Reagent; Reporting; Research; Resolution; Risk; SARS-CoV-2 infection; Safety; Sampling; Severity of illness; Site; Systems Biology; Therapeutic Agents; Therapeutic Intervention; Time; Training; Vaccines; Viral; Viral Pneumonia; Virus Replication; Virus Shedding; Visit; age group; base; clinical phenotype; clinical research site; cohort; data management; design; digital; evidence base; follow-up; immunogenicity; member; mortality; novel coronavirus; off-label use; older patient; pandemic disease; primary endpoint; quality assurance; respiratory; safety outcomes; sample collection; surveillance study; targeted treatment; vaccine access; working group

IMmunoPhenotyping Assessment in a COVID-19 Cohort (IMPACC): Clinical and Data Coordinating Center (CDCC) Project summary In December 2019, a cluster of respiratory illness in Wuhan, China defined the onset of a global pandemic involving a novel coronavirus (SARS-CoV-2) with associated respiratory disease (COVID-19). There are major research efforts underway to understand SARS-CoV-2 infections and the associated COVID-19 disease. The IMmunoPhenotyping Assessment Covid-19 Cohort (IMPACC) surveillance study is based upon an observational cohort that will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions. The goal of the surveillance study is to identify immunophenotypic and genomic features of COVID-19-related susceptibility and/or progression. The IMPACC Clinical and Data Coordinating Center (CDCC) will provide clinical and data coordination support for the IMPACC study. This includes comprehensive study coordination and project management support across all participating IMPACC clinical and Core laboratory sites, including initial site training and ongoing study support through the completion of study enrollment and follow-up. The CDCC will provide clinical sites with real-time sample tracking and data capture capabilities, including all necessary supplies and reagents for sample collection, electronic case report forms (eCRFs) for data entry, and quality control/quality assurance (QC/QA) processes to ensure high quality sample collection and data capture. Finally, the CDCC will design digital infrastructure components to facilitate data management, data storage, and data analysis of study endpoint and safety data, including interim and final analysis of primary endpoints, ongoing safety and outcome monitoring, and bioinformatics analytic support for secondary/exploratory endpoints.

COVID-19 队列中的免疫表型评估 (IMPACC)：临床和数据协调 中心（CDC） 项目概要 2019 年 12 月，中国武汉发生的一系列呼吸道疾病引发了全球大流行 涉及一种伴有相关呼吸道疾病 (COVID-19) 的新型冠状病毒 (SARS-CoV-2)。主要有 正在进行的研究工作旨在了解 SARS-CoV-2 感染和相关的 COVID-19 疾病。这 IMmunoPhenotyping Assessment Covid-19 Cohort (IMPACC) 监测研究基于一项观察性研究 将与生物采样协调收集详细的临床、实验室和放射学数据的队列 血液和呼吸道分泌物以及鼻腔分泌物中的病毒脱落。监测研究的目标是 确定与 COVID-19 相关的易感性和/或进展的免疫表型和基因组特征。 IMPACC临床和数据协调中心（CDCC）将提供临床和数据协调支持 用于 IMPACC 研究。这包括全面的研究协调和项目管理支持 所有参与 IMPACC 临床和核心实验室站点，包括初始站点培训和持续研究支持 通过完成研究登记和随访。 CDCC 将为临床中心提供实时 样品跟踪和数据采集能力，包括样品所需的所有用品和试剂 收集、用于数据输入的电子病例报告表 (eCRF) 以及质量控制/质量保证 (QC/QA) 确保高质量样本采集和数据采集的流程。最后，CDCC 将设计数字 基础设施组件，以促进研究终点的数据管理、数据存储和数据分析 安全数据，包括主要终点的中期和最终分析、持续的安全性和结果监测， 以及对次要/探索性终点的生物信息学分析支持。

项目成果

Antimicrobial peptide LL-37 and recombinant human mannose-binding lectin express distinct age- and pathogen-specific antimicrobial activity in human newborn cord blood in vitro.

抗菌肽 LL-37 和重组人甘露糖结合凝集素在体外人新生儿脐带血中表现出独特的年龄和病原体特异性抗菌活性。

• 发表时间: 2018
• 作者: Scheid, Annette;Li, Ning;Jeffers, Carleen;Borriello, Francesco;Joshi, Sweta;Ozonoff, Al;Pettengill, Matthew;Levy, Ofer
• 通讯作者: Levy, Ofer

Microphysiologic Human Tissue Constructs Reproduce Autologous Age-Specific BCG and HBV Primary Immunization in vitro.

微生理人体组织构建体在体外复制自体年龄特异性 BCG 和 HBV 初次免疫。

• 发表时间: 2018
• 作者: Sanchez;Stevens, Chad R;Bettencourt, Ian A;Flynn, Peter J;Schmitz;Metser, Gil;Hamm, David;Jensen, Kristoffer J;Benn, Christine;Levy, Ofer
• 通讯作者: Levy, Ofer

OMIC Technologies and Vaccine Development: From the Identification of Vulnerable Individuals to the Formulation of Invulnerable Vaccines.

OMIC 技术和疫苗开发：从识别弱势个体到配制无害疫苗。

• 发表时间: 2019
• 作者: Cotugno, Nicola;Ruggiero, Alessandra;Santilli, Veronica;Manno, Emma Concetta;Rocca, Salvatore;Zicari, Sonia;Amodio, Donato;Colucci, Manuela;Rossi, Paolo;Levy, Ofer;Martinon;Pollard, Andrew J;Palma, Paolo
• 通讯作者: Palma, Paolo

Neonatal monocytes demonstrate impaired homeostatic extravasation into a microphysiological human vascular model.

新生儿单核细胞表现出受损的稳态外渗到微生理人体血管模型中。

• 发表时间: 2020-10-20
• 影响因子: 4.6
• 作者: Sanchez;Morrocchi, Elena;Cooney, Mitchell;Soni, Dheeraj;Khatun, Rahima;Palma, Paolo;Dowling, David J;Levy, Ofer
• 通讯作者: Levy, Ofer

Preparing for Life: Plasma Proteome Changes and Immune System Development During the First Week of Human Life.

为生命做好准备：人类生命第一周的血浆蛋白质组变化和免疫系统发育。

• 发表时间: 2020
• 作者: Bennike, Tue Bjerg;Fatou, Benoit;Angelidou, Asimenia;Diray;Falsafi, Reza;Ford, Rebecca;Gill, Erin E;van Haren, Simon D;Idoko, Olubukola T;Lee, Amy H;Ben;Pomat, William S;Shannon, Casey P;Smolen, Kinga K;Tebbutt, Scott
• 通讯作者: Tebbutt, Scott