Assessment of the Natural History of Coagulopathy in COVID-19

The purpose of this project is to describe the natural history of coagulopathy among COVID-19 patients. Activities include development of a study synopsis to assess the risks of arterial and venous thromboembolic events, and related death, among COVID-19 patients, assessment of feasibility, and implementation of the study synopsis within select Sentinel Data Partners with electronic health records (EHR) and claims data. The Sentinel Operations Center (SOC) and FDA are partnering with leading infectious disease and hematology specialists from the University of Pennsylvania Perelman School of Medicine on this activity. The workgroup is actively engaging with the FDA Reagan Udall Foundation (RUF) Evidence Accelerator Parallel Analysis Workgroup.