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Principal Investigator: OFER LEVY
Organization: BOSTON CHILDREN'S HOSPITAL
Fiscal Year: 2021
Award: $800,481
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 corona virus><2019 novel coronavirus><2019-nCoV><Aching muscles><Active Follow-up><Architecture><Award><Bio-Informatics><Bioinformatics><Biological><Biological Markers><Blood Sample><Blood specimen><COVID infected patient><COVID patient><COVID positive patient><COVID-19><COVID-19 infected patient><COVID-19 infection><COVID-19 patient><COVID-19 positive patient><COVID-19 virus><COVID19><COVID19 infection><COVID19 patient><COVID19 positive patient><COVID19 virus><CV-19><CV19><Case Report Form><China><Clinical><Clinical Data><Clinical Trials><CoV emergence><CoV-2><CoV2><Cohort Studies><Collection><Concurrent Studies><Controlled Clinical Trials><Conventional X-Ray><Coughing><Critical Care><Data><Data Analyses><Data Analysis><Data Collection><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><Home visitation><Hospital Admission><Hospitalization><Hospitals><Host Factor><Host Factor Protein><House Call><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><Patient Outcomes Assessments><Patient Reported Measures><Patient Reported Outcomes><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 corona virus 2><SARS-CoV-2><SARS-CoV-2 infected patient><SARS-CoV-2 infection><SARS-CoV-2 patient><SARS-CoV-2 positive patient><SARS-CoV2><SARS-CoV2 infection><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Safety><Sampling><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome related corona virus 2><Severity of illness><Site><Susceptibility><Systems Biology><Therapeutic Agents><Therapeutic Intervention><Time><Training><Vaccines><Viral><Viral Pneumonia><Viral Shedding><Virus Replication><Virus Shedding><Visit><Wuhan coronavirus><X-Ray Imaging><X-Ray Medical Imaging><Xray imaging><Xray medical imaging><access to vaccination><access to vaccines><active followup><age group><base><bio-markers><biologic marker><biomarker><clinical phenotype><clinical research site><clinical site><cohort><conventional Xray><corona virus disease 2019><corona virus emergence><coronavirus disease 2019><coronavirus disease 2019 infected patient><coronavirus disease 2019 infection><coronavirus disease 2019 patient><coronavirus disease 2019 positive patient><coronavirus disease 2019 virus><coronavirus disease infected patient><coronavirus disease patient><coronavirus disease positive patient><coronavirus emergence><coronavirus patient><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 corona virus><emergent coronavirus><emerging CoV><emerging corona virus><emerging coronavirus><enroll><evidence base><febrile><febris><follow up><follow-up><followed up><followup><hCoV19><home visit><host response><immune system response><immunogenicity><immunophenotype><immunoresponse><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><intervention therapy><interventional strategy><lung disorder><member><mortality><nCoV><nCoV2><new CoV><new corona virus><new coronavirus><newborn child><newborn children><novel CoV><novel corona virus><novel coronavirus><off-label application><off-label prescribing><off-label use><older patient><pandemic><pandemic disease><patient infected with COVID><patient infected with COVID-19><patient infected with SARS-CoV-2><patient infected with coronavirus disease><patient infected with coronavirus disease 2019><patient infected with severe acute respiratory syndrome coronavirus 2><patient with COVID><patient with COVID-19><patient with COVID19><patient with SARS-CoV-2><patient with coronavirus disease><patient with coronavirus disease 2019><patient with severe acute respiratory distress syndrome coronavirus 2><primary end point><primary endpoint><quality assurance><respiratory><safety outcomes><sample collection><severe acute respiratory syndrome coronavirus 2 infected patient><severe acute respiratory syndrome coronavirus 2 patient><severe acute respiratory syndrome coronavirus 2 positive patient><specimen collection><surveillance study><targeted drug therapy><targeted drug treatments><targeted therapeutic><targeted therapeutic agents><targeted therapy><targeted treatment><vaccination access><vaccination availability><vaccine access><vaccine availability><viral multiplication><viral replication><virus multiplication><work group><working group>