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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
Racial and Ethnic Differences in COVID-19 Treatment and Mortality in TriNetX: A Descriptive Analysis

The goal of this analysis was to describe COVID-19 therapeutic treatment and death among patients who were hospitalized with COVID-19 and among patients with severe COVID-19, stratified by racial and ethnic group in the TriNetX platform. In addition to describing these groups overall, we also described the subset of each group with evidence of vaccination against COVID-19. 

This analysis contains four reports: 

  • Report 1: The study period includes data from January 1, 2021 to April 30, 2021 and contains data from 36 health care organizations (HCOs), provided through the TriNetX Live™ platform in their USA Network. The query was run on June 21, 2022.
  • Report 2: The study period includes data from May 1, 2021 to August 31, 2021 and contains data from 36 HCOs, provided through the TriNetX Live™ platform in their USA Network. The query was run on June 13, 2022.
  • Report 3: The study period includes data from September 1, 2021 to December 31, 2021 and contains data from 36 HCOs, provided through the TriNetX Live™ platform in their USA Network. The query was run on June 30, 2022.
  • Report 4: The study period includes data from January 1, 2022 to April 30, 2022 and contains data from 36 HCOs, provided through the TriNetX Live™ platform in their USA Network. The query was run on July 12, 2022.
Details
Baricitinib or Tocilizumab Use in Hospitalized Patients with a COVID-19 Diagnosis: A Descriptive Analysis

The objective of this request was to identify patients of all ages with evidence of baricitinib or tocilizumab use in the hospital setting, with and without a COVID-19 diagnosis and/or COVID-19 positive lab. We also assessed evidence of concomitant use of remdesivir with baricitinib and systemic corticosteroids with tocilizumab.

The study period includes data from April 1, 2020 to March 31, 2021. We distributed this request to 22 National Patient-Centered Clinical Research Network (PCORnet) DataMarts on September 21, 2021.

Details
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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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. 

Details
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.

Details
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.

Details
Title Date
Racial and Ethnic Differences in COVID-19 Treatment and Mortality in TriNetX: A Descriptive Analysis
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