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
Hospitalization and Anaphylaxis Following Monoclonal Antibodies (mAb) Use in Patients with COVID-19: A Descriptive Analysis 07/14/2022
Use of Monoclonal Antibodies (mAbs) Under an Emergency Use Authorization (EUA) in Patients with COVID-19 Diagnosis: A Descriptive Analysis 06/24/2022
Bamlanivimab, Bamlanivimab and Etesevimab, and Casirivimab-Imdevimab Use in Patients with COVID-19: A Descriptive Analysis 06/14/2022
Outpatient Corticosteroid Use in Patients With COVID-19: An Updated Descriptive Analysis 06/02/2022
Outpatient Corticosteroid Use in Patients With COVID-19: A Descriptive Analysis 06/01/2022
Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021 04/08/2022
Validation of Diagnosis Codes to Identify Hospitalized COVID-19 Patients in Health Care Claims Data 12/16/2021
A Comparison of Race and Ethnicity in COVID-19 Testing, Hospitalization, and Mortality 12/08/2021
Strategies for the Use of Real-World Data to Conduct COVID-19-Related Pharmacoepidemiology 08/25/2021
Outpatient-Identified COVID-19 and Subsequent Hospitalized Thrombotic Events 08/23/2021
Comparing Outcomes in Trial-Eligible vs Real-World COVID-19 Patients: The Case of Invasive Mechanical Ventilation 08/23/2021
A COVID‐19‐Ready Public Health Surveillance System: The FDA's Sentinel System 04/02/2021
Advancing Scalable Natural Language Processing Approaches for Unstructured Electronic Health Record Data 02/26/2021
COVID-19 Pregnancy Study Implementation 02/24/2021
Thrombotic Events and Death in Inpatient-Identified COVID-19 Patients 12/21/2020
Thrombotic Events in COVID-19 Patients Not Requiring Hospitalization at the Time of Diagnosis 11/24/2020
Assessment of the Natural History of Coagulopathy in COVID-19 10/21/2020
Master Protocol Development: COVID-19 Natural History 10/13/2020
Addition of COVID Laboratory Results Data to the Sentinel Common Data Model (SCDM) and Establishment of a “Freshest Feasible” Rapid COVID-19 Data Resource 09/14/2020
HCA COVID-19 Activities: Monitoring of Critical Drugs and Assessment of Natural History of Disease 07/22/2020
TriNetX Rapid Querying 06/05/2020
COVID MyStudies Mobile App for E-Consent 06/01/2020
Validation of Hospitalized COVID-19 Detected from Claims-Based Algorithms 05/31/2020
Assessing Sentinel System Capability to Collect and Analyze Medical Countermeasure Data for the FDA Office of Counterterrorism and Emerging Threats (OCET) 05/14/2020
Sentinel COVID-19 Evidence Accelerator Series 05/13/2020
Near Real-Time Monitoring of Critical Drugs for the Care of Patients with COVID-19 04/20/2020
Horizon Scan of Electronic Health Record Databases 04/07/2020