CCTSI Participation in the National COVID Cohort Collaborative (N3C)

PROJECT SUMMARY/Abstract: This application is being submitted by the Colorado Clinical and Translational Sciences Institute (CCTSI; UL1TR002535) in response to NOT-TR-20-028, Clinical and Translational Science Award (CTSA) ProgramApplications to Address 2019 Novel Coronavirus (COVID-19) Public Heath Need, and PA-18-591, AdministrativeSupplements to Existing NIH Grants and Cooperative Agreements.The COVID-19 pandemic has had unprecedented global impact. In some patients, SARS-CoV-2 infection leadsto pneumonia, hyperinflammation, hypoxemic respiratory failure, acute respiratory distress syndrome, multipleorgan dysfunction syndrome, and death. Although rapid advances have been made in identifying risk factors forsevere COVID-19, there are currently no FDA-approved SARS-CoV-2 vaccines and only one emergency FDA-approved therapeutic (remdesivir). Most U.S. reports of COVID-19 clinical characteristics, treatments, andoutcomes have been from a single hospital or health system or have presented only summary statistics obtainedusing a federated query design. Progress in this field is significantly impaired by the lack of a large,centralized multi-center, row-level, high-granularity clinical data resource with which to develop and testhypotheses and develop novel predictive and diagnostic computational tools. Therefore, there is an urgent publichealth need to build such a centralized resource.The Specific Aims for this UL1 Administrative Supplement are: 1. Build a deep and adaptive COVID-19 ClinicalData Mart. We will leverage the CCTSI Informatics Core and our enterprise data warehouse to create a COVID-19 Data Mart that will include rich clinical data extracted from the electronic health records of large adult andpediatric health systems. We will harmonize the Data Mart to N3C's preferred common data model, theObservational Medical Outcomes Partnership (OMOP) model. 2. Share CCTSI COVID-19 case and controldata with N3C. We will secure appropriate regulatory approvals and data transfer agreements and securelytransfer harmonized COVID-19 data to N3C. 3. Co-Lead N3C Clinical Scenarios and Analytics. As one of theonly practicing ICU physicians in the CTSA Informatics Enterprise Committee, the CCTSI Informatics CoreDirector, Dr. Tellen Bennett, will play a key role in N3C by engaging other clinician-scientists and leadingprioritization and execution of clinical analyses. Taken together, these efforts will accelerate clinical and datascience research toward the development of better therapeutic regimens and predictive and diagnostic tools inCOVID-19.