International Pregistry Study Examines Treatments Used for COVID-19 During Pregnancy
Assessment of Therapeutics for Pregnant Women with COVID-19 Across 47 Countries with a Variety of Ethnic and Socioeconomic Backgrounds.
LOS ANGELES--(BUSINESS WIRE)--#COVID19--In an article published this month in Pharmacoepidemiology and Drug Safety, Pregistry shares findings from its international study of treatments for COVID-19 used during pregnancy. The article titled “COVID-19 pharmacotherapy utilization patterns during pregnancy: International Registry of Coronavirus Exposure in Pregnancy (IRCEP)” is designed to guide future studies aimed at examining the safety of these treatments when used prenatally. Pregistry is a global leader in the development and conduct of observational studies during pregnancy.
In the study of 5,780 pregnant women with COVID-19 from 47 countries, Pregistry collected information on the utilization of medications to treat COVID-19. Women infected with SARS-CoV-2 during pregnancy are at increased risk of developing severe illness and experience a higher rate of preterm births than pregnant women who are not infected. The use of innovative or repurposed therapies to treat COVID-19 patients is widespread; however, there are very limited data regarding the patterns of use and safety of most of these therapeutics when used during pregnancy. The most frequently used therapeutics include azithromycin, steroids, interferon, chloroquine/hydroxychloroquine, anticoagulants, monoclonal antibodies, and remdesivir.
“While women infected with SARS-CoV-2 may develop severe COVID-19 and require pharmacological treatment, little is known about the safety of these products when used during pregnancy,” said Dr. Diego Wyszynski, Pregistry CEO. “Pregistry’s International Registry of Coronavirus Exposure in Pregnancy – the largest of its kind in the world – tracked utilization of medications for COVID-19 during pregnancy to help guide future studies on the safety of these therapeutics.”
According to research from Pregistry, use of therapies increased with disease severity for most medications. Azithromycin use among participants with severe COVID-19 (27.4%) was markedly higher than among mild cases (6.8%), as was use of anticoagulants (9.1% severe, 1.4% mild), steroids (15.3% severe, 1.2% mild), acetaminophen (49.5% severe, 31.0% mild), and nonsteroidal anti-inflammatory drugs (8.1% severe, 1.7% mild). Differences in drug utilization by country were also observed. Russia accounted for 97.8% of self-reported use of interferon medications, while 52.6% of women who used remdesivir were from the U.S. India had the highest reported use of monoclonal antibodies.
“The almost universal exclusion of pregnant women from clinical trials makes observational studies such as the IRCEP an important tool in gathering the evidence needed to enable informed decision-making,” said Dr. Wyszynski. “We learned through this research that future observational studies will need to consider regional differences, trimester of exposure, and disease severity.”
Pregistry is currently conducting the COVID-19 International Drug Pregnancy Registry (COVID-PR). The objective of the COVID-PR is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP. Pregnant and recently pregnant women who experienced COVID-19 during pregnancy are invited to enroll here.
Read the full article: https://onlinelibrary.wiley.com/doi/10.1002/pds.5440
Pregistry is a global leader in the development and conduct of observational studies to assess the safety of medications and vaccines when used during pregnancy. With over 70 pregnancy specialists, covering a range of clinical, preclinical, safety, regulatory, marketing, and IT needs, the focus is on making sure that both mother and baby are healthy and safe and that prescribers have the information needed to be able to explain the potential benefits and risks of medications during pregnancy. Pregistry also offers pregnant people a safe space to connect with a global community of experts and peers at no cost. To learn more, please visit: https://www.pregistry.com. More Pregistry news can be found at Pregistry.com/News.
Diego Wyszynski, MD, MHS, PhD
Chief Executive Officer
Abigail Baker, MA
Director of Communications