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Assessment of the Natural History of Coagulopathy in COVID-19

Basic Details
Date Posted
Status
Complete
Health Outcome(s)
arterial thromboembolic events
death
venous thromboembolic events
Description

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 Reagan-Udall Foundation (RUF) Evidence Accelerator Parallel Analysis Workgroup.

Deliverable(s) (3)
Study Synopsis: Natural History of Coagulopathy in COVID-19 Descriptive Assessment of Coagulopathy Among COVID-19 Patients: Feasibility Data Review Assessment of the Natural History of Coagulopathy in COVID-19 Statistical Analysis Plan
Information
Time Period
January 2020 – most current available data (COVID-19 cohort), October 2018 – April 2019 (influenza cohort)
Population / Cohort
COVID-19 positive individuals
Data Source(s)
Select Sentinel Data Partners
Related Links
Related Link(s)
FDA Sentinel System’s Coronavirus (COVID-19) Activities
Publication: Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients
Presentation: Arterial and Venous Thrombotic Events in Patients with COVID-19 Compared to Influenza
Sentinel COVID-19 Evidence Accelerator Series
Risk of Admission to Hospital with Arterial or Venous Thromboembolism Among Patients Diagnosed in the Ambulatory Setting with COVID-19 Compared with Influenza: Retrospective Cohort Study
Presentation: Hospitalized Arterial and Venous Thrombotic Events in Patients Diagnosed in the Ambulatory Setting with COVID-19 Compared to Influenza
Workgroup Leader(s)

Vincent Lo Re, MD, MSCE; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania

Noelle Cocoros, MPH, DSc; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Workgroup Member(s)

Sarah Dutcher, PhD, MS; Brian Kit, MD, MPH; Silvia Perez-Vilar, PharmD, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Meighan Rogers Driscoll, MPH; Maria Kempner; Laura Hou; Jenice Ko; John Connolly, PhD; Andrew Petrone, MPH; Jolene Mosely; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Dena Carbonari, MS; Allyson Pishko, MD, MSCE; Sean Hennessy, PharmD, PhD; Perelman School of Medicine, University of Pennsylvania Philadelphia, PA