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Principal Investigator: OFER LEVY
Organization: BOSTON CHILDREN'S HOSPITAL
Fiscal Year: 2020
Award: $2,426,447
Funding agency: National Institute of Allergy and Infectious Diseases
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.
Terms: <0-4 weeks old><2019 novel coronavirus><2019-nCoV><Aching muscles><Active Follow-up><Architecture><Award><Bio-Informatics><Bioinformatics><Biological><Biological Markers><Blood Sample><Blood specimen><COVID-19><COVID19><Case Report Form><China><Clinical><Clinical Data><Clinical Trials><CoV emergence><Cohort Studies><Concurrent Studies><Controlled Clinical Trials><Conventional X-Ray><Coughing><Critical Care><Data><Data Analyses><Data Analysis><Data Coordinating Center><Data Coordination Center><Data Storage and Retrieval><Diagnostic Radiology><Diagnostic X-Ray><Diagnostic X-Ray Radiology><Diagnostic radiologic examination><Disease><Disease Progression><Disorder><Engineering / Architecture><Enrollment><Ensure><Fever><Genomics><Goals><Hospital Admission><Hospitalization><Host Factor><Host Factor Protein><Immune response><Immunochemical Immunologic><Immunologic><Immunologic Subtyping><Immunological><Immunological response><Immunologically><Immunologics><Immunophenotyping><Infection><Infrastructure><Integration Host Factors><Intervention><Intervention Strategies><Investigation><Kinetics><Label><Laboratories><Lung diseases><Mainland China><Malaise><Measures><Modeling><Monitor><Morbidity><Morbidity - disease rate><Muscle discomfort><Muscle pain><Muscle pain/fibrositis><Muscle sorenesss><Myalgia><Myalgic><Myodynia><Myoneuralgia><Myosalgia><NIAID><Nasal><Nasal Passages Nose><National Institute of Allergy and Infectious Disease><Neonatal><Newborn Infant><Newborns><Nose><Onset of illness><Parents><Patients><Phenotype><Predisposition><Process><Pulmonary Diseases><Pulmonary Disorder><Pyrexia><Quality Control><Radiography><Reagent><Reporting><Research><Resolution><Respiratory Disease><Respiratory System Disease><Respiratory System Disorder><Respiratory System, Nose, Nasal Passages><Risk><Roentgenography><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Safety><Sampling><Severe acute respiratory syndrome coronavirus 2><Severity of illness><Site><Susceptibility><Systems Biology><Therapeutic Agents><Therapeutic Intervention><Time><Training><Vaccination><Vaccines><Viral><Viral Pneumonia><Viral Shedding><Virus Replication><Virus Shedding><Wuhan coronavirus><X-Ray Imaging><X-Ray Medical Imaging><Xray imaging><Xray medical imaging><active followup><age group><base><bio-markers><biologic marker><biomarker><clinical phenotype><clinical research site><clinical site><cohort><conventional Xray><corona virus disease 2019><coronavirus disease 2019><coronavirus emergence><data interpretation><data management><data retrieval><data storage><design><designing><diagnostic Xray><diagnostic Xray radiology><digital><disease of the lung><disease onset><disease severity><disorder of the lung><disorder onset><elderly patient><emergent CoV><emergent coronavirus><emerging CoV><emerging coronavirus><enroll><evidence base><febrile><febris><follow up><follow-up><followed up><followup><host response><immunogenicity><immunophenotype><immunoresponse><intervention therapy><interventional strategy><lung disorder><mortality><nCoV><new CoV><new coronavirus><newborn child><newborn children><novel CoV><novel coronavirus><off-label application><off-label prescribing><off-label use><older patient><pandemic><pandemic disease><primary end point><primary endpoint><quality assurance><respiratory><safety outcomes><sample collection><specimen collection><surveillance study><targeted drug therapy><targeted drug treatments><targeted therapeutic><targeted therapeutic agents><targeted therapy><targeted treatment><viral multiplication><viral replication><virus multiplication>