IMmunoPhenotyping Assessment in a COVID-19 Cohort (IMPACC): Clinical and Data Coordinating Center (CDCC)

IMmunoPhenotyping Assessment in a COVID-19 Cohort (IMPACC): Clinical and Data CoordinatingCenter (CDCC)Project summaryIn December 2019, a cluster of respiratory illness in Wuhan, China defined the onset of a global pandemicinvolving a novel coronavirus (SARS-CoV-2) with associated respiratory disease (COVID-19). There are majorresearch efforts underway to understand SARS-CoV-2 infections and the associated COVID-19 disease. TheIMmunoPhenotyping Assessment Covid-19 Cohort (IMPACC) surveillance study is based upon an observationalcohort that will collect detailed clinical, laboratory, and radiographic data in coordination with biologic samplingof blood and respiratory secretions and viral shedding in nasal secretions. The goal of the surveillance study isto 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 supportfor the IMPACC study. This includes comprehensive study coordination and project management support acrossall participating IMPACC clinical and Core laboratory sites, including initial site training and ongoing study supportthrough the completion of study enrollment and follow-up. The CDCC will provide clinical sites with real-timesample tracking and data capture capabilities, including all necessary supplies and reagents for samplecollection, 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 digitalinfrastructure components to facilitate data management, data storage, and data analysis of study endpoint andsafety data, including interim and final analysis of primary endpoints, ongoing safety and outcome monitoring,and bioinformatics analytic support for secondary/exploratory endpoints.