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: 10205742
• 负责人: OFER LEVY
• 金额: $ 80.05万
• 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: 2021-01-28 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10205742
• 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.

新冠肺炎队列中的免疫表型评估：临床和数据协调 中心(CDCC) 项目总结 2019年12月，武汉呼吸道疾病聚集性疫情，中国定义了一场全球大流行的爆发 涉及一种新的冠状病毒(SARS-CoV-2)并伴随呼吸道疾病(新冠肺炎)。有主要的 了解SARS-CoV-2感染和相关的新冠肺炎疾病的研究工作正在进行中。这个 免疫表型评估新冠肺炎队列(IMPACC)监测研究基于观察性 将结合生物采样收集详细的临床、实验室和放射学数据的队列 血液和呼吸道分泌物以及鼻分泌物中的病毒脱落。监督研究的目标是 确定新冠肺炎相关易感性和/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的研究。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 通过完成招生录取和后续学习。CDCC将为临床站点提供实时 样本跟踪和数据捕获能力，包括所有必要的样本供应品和试剂 收集、用于数据输入的电子案例报告表格(ECRF)和质量控制/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将设计数字化 基础设施组件，以促进研究终点和数据的数据管理、数据存储和数据分析 安全数据，包括对主要终点的临时和最终分析、持续的安全和结果监测， 以及为次要/探索性终端提供生物信息学分析支持。