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

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.

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.

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.

​​​​​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. 

​​​​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. 

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. 

​​​​​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. 

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.

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.

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).