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

COVID-19 may increase the risk of developing severe illness among pregnant patients. Several studies have described clinical characteristics and complications among pregnancies with COVID-19, but data on the impact of maternal COVID-19 on adverse infant outcomes is limited. 

This presentation implements the CONSIGN protocol (COVID-19 infection and medicines in pregnancy), as part of an international collaboration across Europe, USA, and Canada, to examine the risk of adverse outcomes in infants delivered by pregnant patients with COVID-19 compared to pregnant patients without COVID-19. It was presented at the 2024 ISPE Annual Meeting.
 

COVID-19 pandemic containment measures in the U.S. resulted in changes in the provision and utilization of health services. Validity of pharmacoepidemiologic studies using claims data from this time may be impacted.

This poster investigates the impact of changing healthcare utilization on ascertainment of study variables by replicating a known positive association using 2018-2022 data. It was presented at the 2024 ISPE Annual Meeting.

This analysis supports the U.S. Food and Drug Administration (FDA)'s participation in the European Medicines Agency (EMA)-funded project, CONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)1 , to understand the natural history of COVID-19 in pregnant patients. For other analyses supporting the CONSIGN protocol, please see Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis and Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis.

The goal of this analysis was to evaluate the prevalence of medication use among pregnant patients with COVID-19 compared to two 1:1 propensity-score matched comparator cohorts and to describe maternal at-risk conditions and the severity of COVID-19 in the Rapid COVID-19 Sentinel Distributed Database (SDD). 

The study period includes data from January 1, 2020 to December 31, 2022. We distributed this request to seven Sentinel Data Partners on June 30, 2023.

This analysis includes two reports:

• Report 1: This report includes pregnant patients without COVID-19 as the comparator cohort (Objective 1b of the COVID-19 pregnancy study protocol).
• Report 2: This report includes non-pregnant patients with COVID-19 as the comparator cohort (objectives 1c and 2b of the COVID-19 pregnancy study protocol).

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

• 1CONSIGN study: COVID-19 infection and medicines in pregnancy- a multinational registry based study. European Network of Centres for Pharmacoepidemiology & Pharmacovigilance. Accessed June 1, 2022. https://catalogues.ema.europa.eu/node/3303/administrative-details

This analysis supports the U.S. Food and Drug Administration (FDA)'s participation in the European Medicines Agency (EMA)-funded project, CONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)1 , to understand the natural history of COVID-19 in pregnant patients. For other analyses supporting the CONSIGN protocol, please see Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis and Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis.

In this request, we completed the following objectives: A) estimated the prevalence of adverse maternal outcomes by trimester of COVID-19 infection and by COVID-19 severity among pregnant patients with COVID-19; B) compared rates of adverse maternal outcomes among pregnant patients with COVID-19 to those without COVID-19 using a 1:1 propensity score (PS)-matched analysis; and C) evaluated the impact of medications used to treat COVID-19 on adverse maternal outcomes by assessing incidence of adverse maternal outcomes among pregnant patients with COVID-19 that had medication use in the 30 days pre-COVID-19 or post-COVID-19 and those not exposed to medications in the 30 days pre- or post-COVID-19.

The study period includes data from January 1, 2020 to November 30, 2023. We distributed this request to seven Sentinel Data Partners on February 8, 2024.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

• 1CONSIGN study: COVID-19 infection and medicines in pregnancy- a multinational registry based study. European Network of Centres for Pharmacoepidemiology & Pharmacovigilance. Accessed June 1, 2022. https://catalogues.ema.europa.eu/node/3303/administrative-details

This analysis supports the U.S. Food and Drug Administration (FDA)'s participation in the European Medicines Agency (EMA)-funded project, CONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)1 , to understand the natural history of COVID-19 in pregnant patients. For other analyses supporting the CONSIGN protocol, please see Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis and Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis.

The goals of this analysis were to complete the following objectives: A) to estimate the prevalence of adverse infant outcomes by trimester of COVID-19 identification and by COVID-19 severity among pregnant patients with COVID-19; B) to compare rates of adverse infant outcomes among pregnant patients with COVID-19 to pregnant patients without COVID-19 using a 1:1 propensity score (PS)-matched analysis; and C) to evaluate the impact of medications used to treat COVID-19 on adverse infant outcomes by assessing incidence of adverse infant outcomes among pregnant patients with COVID-19 that had medication use in the 30 days pre-COVID-19 or post-COVID-19 and those not exposed to medications in the 30 days pre- or post-COVID-19.

The study period includes data from January 1, 2020 to December 31, 2022. We distributed this request to four Sentinel Data Partners on June 30, 2023.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

• 1CONSIGN study: COVID-19 infection and medicines in pregnancy- a multinational registry based study. European Network of Centres for Pharmacoepidemiology & Pharmacovigilance. Accessed June 1, 2022. https://catalogues.ema.europa.eu/node/3303/administrative-details

In this report, we describe the concomitant use of drugs that interact with Paxlovid (nirmatrelvir/ritonavir), a co-packaged oral drug product consisting of nirmatrelvir and ritonavir, among patients treated with nirmatrelvir/ritonavir and patients with an outpatient diagnosis of COVID-19. The main purpose is to estimate the proportion of the nirmatrelvir/ritonavir-eligible population (i.e., adults who are at high risk for development of severe COVID-19) or nirmatrelvir/ritonavir users who are taking concomitant medications that have drug-drug interactions (DDI) with nirmatrelvir/ritonavir.

The study period includes data from December 22, 2021 to December 31, 2022. We distributed this request to six Sentinel Rapid COVID-19 Data Partners on April 3, 2023.

In this report, we described cohorts identified by five diagnosis code‐based algorithms designed to detect COVID-19 in the inpatient (IP) setting. We calculated the positive predictive value (PPV) and sensitivity of each algorithm to compare algorithm performance, using diagnostic nucleic acid amplification (NAA) test laboratory result as our reference standard. This report describes Phase Two of a two‐phase project.

We distributed this request to six Sentinel Data Partners on October 30, 2020. The study period includes data from February 20, 2020 to October 17, 2020.

Automated phenotyping algorithms can reduce development time and operator dependence compared to manually developed algorithms. One such approach, PheNorm, has performed well for identifying chronic health conditions, but its performance for acute conditions is largely unknown. We evaluated PheNorm applied to symptomatic COVID-19 disease to investigate its potential feasibility for rapid phenotyping of acute health conditions.

In this report, we identified individuals with COVID‐19 in the ambulatory and inpatient settings and examined inpatient arterial thrombotic events and inpatient venous thrombotic events among those individuals, as well as all‐cause mortality following an inpatient thrombotic event. This analysis was conducted as a follow‐up to the study described here.

The study period includes data from April 1, 2020 to May 4, 2022. We distributed this request to six Sentinel Data Partners on January 10, 2023. 

All of the code lists for this work have been published previously and can be found in this manuscript. 

The goal of this request was to describe the baseline and clinical characteristics of patients with various stages of COVID-19 and explore whether racial and/or ethnic disparities exist. COVID-19 stages included: tested, tested positive, case, hospitalized, and critically hospitalized.

The study period included data from April 1, 2020 to March 31, 2021. Data from 22 PCORnet Data Marts are included in this report. We distributed this request on June 14, 2022.