IMPACC convalescent data collection, including Patient Reported Outcomes (PROs) and home visit sampling

Levy, Ofer

Abstract

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.

Public Health Relevance

The primary objective for this study is to describe the relationship between specific immunologic assessments and severity of illness in hospitalized patients with COVID-19, controlling for the illness onset, concurrent participation in clinical trials or off-label use of investigational (or approved) therapeutic agents for COVID-19.