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
基本信息
- 批准号:10205742
- 负责人:
- 金额:$ 80.05万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:2019-nCoVArchitectureAwardBioinformaticsBiologicalBiological MarkersBlood specimenCOVID-19COVID-19 patientCase Report FormChinaClinicalClinical DataClinical TrialsCohort StudiesCollectionControlled Clinical TrialsCoughingCritical CareDataData AnalysesData CollectionData Coordinating CenterData Storage and RetrievalDiagnostic radiologic examinationDiseaseDisease ProgressionEnrollmentEnsureFeverGenomicsGoalsHome visitationHospitalizationHospitalsImmune responseImmunologicsImmunophenotypingInfectionInfrastructureIntegration Host FactorsInterventionInvestigationKineticsLabelLaboratoriesLung diseasesMalaiseMeasuresModelingMonitorMorbidity - disease rateMyalgiaNational Institute of Allergy and Infectious DiseaseNeonatalNewborn InfantNoseOnset of illnessParentsPatient Outcomes AssessmentsPatientsPhenotypePredispositionProcessQuality ControlReagentReportingResearchResolutionRiskSARS-CoV-2 infectionSafetySamplingSeverity of illnessSiteSystems BiologyTherapeutic AgentsTherapeutic InterventionTimeTrainingVaccinesViralViral PneumoniaVirus ReplicationVirus SheddingVisitage groupbaseclinical phenotypeclinical research sitecohortdata managementdesigndigitalevidence basefollow-upimmunogenicitymembermortalitynovel coronavirusoff-label useolder patientpandemic diseaseprimary endpointquality assurancerespiratorysafety outcomessample collectionsurveillance studytargeted treatmentvaccine accessworking group
项目摘要
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('OFER LEVY', 18)}}的其他基金
Immune development in early life (IDEAL) shapes vaccine response, respiratory infectious diseaseand asthma
生命早期的免疫发育 (IDEAL) 影响疫苗反应、呼吸道传染病和哮喘
- 批准号:
10435035 - 财政年份:2022
- 资助金额:
$ 80.05万 - 项目类别:
Project 3: In vitro modeling to define mechanisms of childhood vaccine response, susceptibility to respiratory infectious disease and asthma
项目 3:体外建模以确定儿童疫苗反应、呼吸道传染病和哮喘易感性机制
- 批准号:
10589826 - 财政年份:2022
- 资助金额:
$ 80.05万 - 项目类别:
Project 3: In vitro modeling to define mechanisms of childhood vaccine response, susceptibility to respiratory infectious disease and asthma
项目 3:体外建模以确定儿童疫苗反应、呼吸道传染病和哮喘易感性机制
- 批准号:
10435043 - 财政年份:2022
- 资助金额:
$ 80.05万 - 项目类别:
Immune development in early life (IDEAL) shapes vaccine response, respiratory infectious diseaseand asthma
生命早期的免疫发育 (IDEAL) 影响疫苗反应、呼吸道传染病和哮喘
- 批准号:
10589800 - 财政年份:2022
- 资助金额:
$ 80.05万 - 项目类别:
Administrative Core: IDEAL shapes vaccine response, susceptibility to respiratory infectious disease and asthma
管理核心:IDEAL 影响疫苗反应、呼吸道传染病和哮喘的易感性
- 批准号:
10435036 - 财政年份:2022
- 资助金额:
$ 80.05万 - 项目类别:
Administrative Core: IDEAL shapes vaccine response, susceptibility to respiratory infectious disease and asthma
管理核心:IDEAL 影响疫苗反应、呼吸道传染病和哮喘的易感性
- 批准号:
10589801 - 财政年份:2022
- 资助金额:
$ 80.05万 - 项目类别:
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 - 财政年份:2021
- 资助金额:
$ 80.05万 - 项目类别:
Newborn cohorts to discover and validate biomarkers of neonatal vaccine immunogenicity
新生儿队列发现和验证新生儿疫苗免疫原性的生物标志物
- 批准号:
10323182 - 财政年份:2020
- 资助金额:
$ 80.05万 - 项目类别:
Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity
识别新生儿疫苗免疫原性生物标志物的系统生物学
- 批准号:
10221106 - 财政年份:2020
- 资助金额:
$ 80.05万 - 项目类别:
Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity
识别新生儿疫苗免疫原性生物标志物的系统生物学
- 批准号:
10265669 - 财政年份:2020
- 资助金额:
$ 80.05万 - 项目类别:
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