Skip to main content

FDA Sentinel System's Coronavirus (COVID-19) Activities

FDA’s Sentinel System is 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 illness among hospitalized patients, and evaluating the treatment impact of therapies actively being used under real-world conditions. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity and also visit:

Title Date
Data-driven Phenotyping Algorithms for Acute Health Conditions: Applying PheNorm to COVID-19 03/25/2024
Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States
Racial and Ethnic Differences in COVID-19 Treatment and Mortality in TriNetX: A Descriptive Analysis
High Dose Dexamethasone for COVID-19 Not Common in a Large US Hospital Network
Baricitinib or Tocilizumab Use in Hospitalized Patients with a COVID-19 Diagnosis: A Descriptive Analysis
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
Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients
Racial Differences in U.S. COVID-19 Positivity, Hospitalization, and Mortality
Systemic Corticosteroids for COVID-19 in U.S. Outpatient Settings
Arterial and Venous Thrombotic Events in Patients with COVID-19 Compared to Influenza
Characterizing Medication Use Among Pregnancies with COVID-19 in the Sentinel System
Use of Monoclonal Antibodies (mAbs) Under an Emergency Use Authorization (EUA) in Patients with COVID-19 Diagnosis: An Updated Descriptive Analysis
Differences in COVID-19 Testing, Positivity, Hospitalization, and Mortality by Race and Ethnicity in the Sentinel Distributed Database: A Descriptive Analysis
Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients
Hospitalization and Anaphylaxis Following Monoclonal Antibodies (mAb) Use in Patients with COVID-19: A Descriptive Analysis
Use of Monoclonal Antibodies (mAbs) Under an Emergency Use Authorization (EUA) in Patients with COVID-19 Diagnosis: A Descriptive Analysis
Bamlanivimab, Bamlanivimab and Etesevimab, and Casirivimab-Imdevimab Use in Patients with COVID-19: A Descriptive Analysis
Outpatient Corticosteroid Use in Patients With COVID-19: An Updated Descriptive Analysis
Outpatient Corticosteroid Use in Patients With COVID-19: A Descriptive Analysis
Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021
Validation of Diagnosis Codes to Identify Hospitalized COVID-19 Patients in Health Care Claims Data
Racial Differences in COVID-19 Outcomes (2020-2021)
Natural History of Coagulopathy in COVID-19
Strategies for the Use of Real-World Data to Conduct COVID-19-Related Pharmacoepidemiology
Outpatient-Identified COVID-19 and Subsequent Hospitalized Thrombotic Events
Comparing Outcomes in Trial-Eligible vs Real-World COVID-19 Patients: The Case of Invasive Mechanical Ventilation
A COVID‐19‐Ready Public Health Surveillance System: The FDA's Sentinel System
Advancing Scalable Natural Language Processing Approaches for Unstructured Electronic Health Record Data
COVID-19 Pregnancy Study Implementation
Thrombotic Events and Death in Inpatient-Identified COVID-19 Patients
Thrombotic Events in COVID-19 Patients Not Requiring Hospitalization at the Time of Diagnosis
Assessment of the Natural History of Coagulopathy in COVID-19
Master Protocol Development: COVID-19 Natural History
Addition of COVID Laboratory Results Data to the Sentinel Common Data Model (SCDM) and Establishment of a “Freshest Feasible” Rapid COVID-19 Data Resource
HCA COVID-19 Activities: Monitoring of Critical Drugs and Assessment of Natural History of Disease
TriNetX Rapid Querying
COVID MyStudies Mobile App for E-Consent
Validation of Hospitalized COVID-19 Detected from Claims-Based Algorithms
Assessing Sentinel System Capability to Collect and Analyze Medical Countermeasure Data for the FDA Office of Counterterrorism and Emerging Threats (OCET)
Sentinel COVID-19 Evidence Accelerator Series
Near Real-Time Monitoring of Critical Drugs for the Care of Patients with COVID-19
Horizon Scan of Electronic Health Record Databases