Sentinel System's COVID-19 Activities
FDA’s Sentinel System engaged in numerous activities to protect and promote public health during the COVID-19 pandemic.
Learn more about this agile response.
Funder: United States Food and Drug Administration (FDA)
PI: Sengwee Darren Toh
Year Initiated: 2020
Project Summary
FDA’s Sentinel System engaged in numerous activities to protect and promote public health during the COVID-19 pandemic, ranging from monitoring the use of drugs, describing the course of COVID-19 illness among hospitalized patients, and evaluating the treatment impact of therapies actively being used under real-world conditions.
The Sentinel System partnered with a range of key collaborators from 2020-2024, including leading scientific experts from academic organizations, HCA Healthcare, the Reagan-Udall Foundation (RUF) for the FDA, and the European Medicines Agency (EMA).
Project Highlights
Three seminal collaborative projects are highlighted from the Sentinel System.
The purpose of this project was to describe the natural history of coagulopathy among COVID-19 patients. The Sentinel Operations Center (SOC) and FDA partnered with leading infectious disease and hematology specialists from the University of Pennsylvania Perelman School of Medicine and the Reagan-Udall Foundation (RUF) Evidence Accelerator to conduct a retrospective cohort study to assess the 90-day risk of arterial thromboembolism and venous thromboembolism in patients hospitalized with COVID-19 before or during COVID-19 vaccine availability, compared to patients hospitalized with influenza. The analysis was implemented within select Sentinel Data Partners with electronic health records (EHR) and claims data.
Results: Hospitalization with COVID-19 both before and during COVID-19 vaccine availability was significantly associated with a higher risk of venous thromboembolism, but not arterial thromboembolism, in comparison to hospitalization with influenza in 2018-2019.
The Sentinel system worked closely with HCA Healthcare on a number of important initiatives, including (though not limited to): monitoring critical drugs and assessing the natural history of disease; examining capture of mechanical ventilation and oxygen use during COVID-19 hospitalization in code-based administrative data versus clinical nursing documentation; and evaluating the treatment and care received by children hospitalized with COVID-19.
This project implemented the following three aims of the CONSIGN protocol:
- To estimate the prevalence of medicines used and compare this among pregnant women with COVID‐19, pregnant women without COVID‐19, and nonpregnant women with COVID‐19.
- To describe severity and clinical outcomes of COVID‐19 disease in pregnant women with COVID‐19, according to treatments received during pregnancy, and compare these data with those of nonpregnant women of reproductive age with COVID‐19.
- To assess and compare the rates of adverse maternal and neonatal outcomes in cohorts of pregnant women with COVID-19 diagnosis in the first, second, or third trimester during pregnancy and pregnant women without COVID-19.
Select Publications
- Treatment and Care Received by Children Hospitalized with COVID-19 in a Large Hospital Network in the United States, February 2020 to September 2021
- Validity of Inpatient Electronic Health Record-Based Measures of Oxygen-Related Therapy in the United States: Lessons Applicable for Studying COVID-19 Endpoints
- Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients
- Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2022
Sentinel's COVID-19 Response
Sentinel's response included monitoring the use of drugs, describing the course of illness among hospitalized patients, and evaluating the treatment impact of therapies actively in use.