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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:

FDA’s Official COVID-19 Drugs Page
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

Studies evaluating thrombotic complications with COVID-19 have focused mainly on patients admitted to hospital. In this retrospective cohort study, we measured the 90-day risk of arterial thromboembolism and venous thromboembolism among patients diagnosed with COVID-19 in the ambulatory (i.e., outpatient, emergency department, or institutional) setting during periods before and during covid-19 vaccine availability and compared results to patients with ambulatory diagnosed influenza.

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Data-Driven Automated Classification Algorithms for Acute Health Conditions: Applying PheNorm to COVID-19 Disease

This presentation discusses the development and implementation of portable, automated phenotyping algorithms for use in postmarket safety studies. It was presented at the American Medical Informatics Association 2022 Annual Symposium.

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Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients

This presentation explores the risk of arterial thromboembolism and venous thromboembolism in patients hospitalized with COVID-19 before or during COVID-19 vaccine availability vs patients hospitalized with influenza. It was presented at the Reagan-Udall Foundation (RUF) COVID-19 Evidence Accelerator.

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Racial Differences in U.S. COVID-19 Positivity, Hospitalization, and Mortality

​​​​​This poster examines racial differences in COVID-19 testing, positivity, hospitalization, and mortality during the first year of the pandemic. It was presented as a Spotlight Poster at the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. 

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Systemic Corticosteroids for COVID-19 in U.S. Outpatient Settings

​​​​This presentation examines new systemic corticosteroid use, including clinical and demographic characteristics and utilization patterns, among non-hospitalized patients with COVID-19 from April 2020 - September 2021 in four large U.S. real-world data sources. It was presented at the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. 

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Arterial and Venous Thrombotic Events in Patients with COVID-19 Compared to Influenza

This presentation explores the risk of inpatient arterial and venous thrombotic events in patients with COVID-19 and compared those risks to patients with influenza. It was presented at the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. 

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Characterizing Medication Use Among Pregnancies with COVID-19 in the Sentinel System

​​​​​This presentation discusses the implementation of the CONSIGN study (COVID-19 Infection and Medicines in Pregnancy) to assess the prevalence of medication use and characterize severity and clinical outcomes in pregnancies with COVID-19 compared to those without COVID-19 and reproductive-aged patients with COVID-19. It was presented at the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. 

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Use of Monoclonal Antibodies (mAbs) Under an Emergency Use Authorization (EUA) in Patients with COVID-19 Diagnosis: An Updated Descriptive Analysis

In this report, we examined counts of individuals using the monoclonal antibodies (mAbs) under an Emergency Use Authorization (EUA) in the Rapid Coronavirus-19 Disease (COVID-19) Sentinel Distributed Database (SDD).

The study period includes data from November 1, 2020 to June 30, 2021. We distributed this request to five Sentinel Data Partners on July, 28, 2021.

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Differences in COVID-19 Testing, Positivity, Hospitalization, and Mortality by Race and Ethnicity in the Sentinel Distributed Database: A Descriptive Analysis

In this report we described racial and ethnic differences in COVID-19 testing, positivity, hospitalization, and mortality among individuals in the rapidly refreshed version of the Sentinel Distributed Database (rSDD) designed for COVID-19 analyses, during the first year of the pandemic.

The study period includes data from April 1, 2020 to March 31, 2021. We distributed this request to six Sentinel Data Partners on January 27, 2022.

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Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients

The incidence of arterial thromboembolism and venous thromboembolism in persons with COVID-19 remains unclear. The objective of this study was to measure the 90-day risk of arterial thromboembolism and venous thromboembolism in patients hospitalized with COVID-19 before or during COVID-19 vaccine availability vs patients hospitalized with influenza. The authors conducted a retrospective cohort study of 41,443 patients hospitalized with COVID-19 before vaccine availability (April-November 2020), 44,194 patients hospitalized with COVID-19 during vaccine availability (December 2020-May 2021), and 8,269 patients hospitalized with influenza (October 2018-April 2019) in the US Food and Drug Administration Sentinel System (data from two national health insurers and four regional integrated health systems).

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Title Date
Utilization of Proton Pump Inhibitors (PPIs), Single-Agent H2 Receptor Antagonists (H2RAs), and Famotidine in Patients with Gastroesophageal Reflux Disease (GERD): A Descriptive Analysis
Proton Pump Inhibitors
Trends in Healthcare Utilization During the COVID-19 Pandemic
Dexamethasone Dose for COVID-19 in a Large U.S. Hospital Network From April 2020 to May 2023
Olumiant (baricitinib) and Actemra (tocilizumab)
COVID-19 Outcomes
COVID-19 Patients
Characterization of COVID-19 Vaccine Data in the Sentinel System
Patterns of Prescribing and Dispensing Medicines Among Non-Hospitalized Pregnant Women with COVID-19: a Prospective Meta-Analysis Pooling Findings from Healthcare Databases in Europe and North America
Comparing the Risk of Adverse Infant Outcomes Among Pregnancies with and without COVID-19 in the Sentinel System
COVID-19 Related Changes in Healthcare Utilization Among Insured Persons in the U.S. and its Impact on Pharmacoepidemiologic Research
Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis
Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis
Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis
Concomitant Use of Medications with Drug-Drug Interactions with Nirmatrelvir and Ritonavir Among Patients Treated with Nirmatrelvir and Ritonavir or Patients with COVID-19: A Descriptive Analysis
Validation of Hospitalized COVID-19 Diagnosis Detected from Claims-Based Algorithms: A Descriptive Analysis
Data-driven Phenotyping Algorithms for Acute Health Conditions: Applying PheNorm to COVID-19
Arterial and Venous Thrombotic Events in Patients with COVID-19 in Inpatient and Ambulatory Settings: A Descriptive Analysis
Racial and Ethnic Differences in the Clinical Characteristics of Patients with Various Stages of COVID-19: A Descriptive Analysis
Capture of Long COVID in TriNetX: A Descriptive Analysis
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
Medication Use Among Pregnant Individuals With COVID-19: A Descriptive Analysis
Data-Driven Automated Classification Algorithms for Acute Health Conditions: Applying PheNorm to COVID-19 Disease
Monitoring of Safety and Effectiveness of COVID-19 Therapeutics: Aim 1 Protocol Development
Racial and Ethnic Differences in COVID-19 Treatment and Mortality in TriNetX: A Descriptive Analysis
COVID-19 Hospitalization and Severe COVID-19 Infection Following Proton Pump Inhibitor (PPI) Use in Patients with Gastroesophageal Reflux Disease (GERD): An Inverse Probability of Treatment Weighting Analysis
Racial and Ethnic Differences in Treatment of Hospitalized and Critical COVID-19, January 2021 - April 2022
High Dose Dexamethasone for COVID-19 Not Common in a Large US Hospital Network
Association Between Race and COVID-19 Outcomes in the United States (2020-2021)
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
Data-Driven Automated Classification Algorithms for Acute Health Conditions: Applying PheNorm to COVID-19 Disease
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