International Pregnancy Registry Studying Effects of Monoclonal Antibodies and Antiviral Drugs for COVID-19 in Pregnant Women

What this Trial Is About

Researchers are evaluating the effects of monoclonal antibodies and antiviral drugs used to treat mild, moderate, or severe COVID-19 in pregnant or recently pregnant women. The study aims to understand how these treatments impact outcomes related to pregnancy, newborns, and infants up to one year of age. This observational study collects data internationally to address the lack of safety information about these medications for mothers and their developing babies. Participants include women 18 years and older who were treated with monoclonal antibodies or antiviral drugs during pregnancy, including exposure up to 90 days before the last menstrual period for monoclonal antibodies. The study also compares outcomes with women treated with other COVID-19 therapies or those hospitalized with COVID-19 but not receiving specific antiviral or monoclonal antibody treatments. Enrollment can occur at any point during pregnancy or up to 30 days after pregnancy ends, with follow-up continuing through the infants first year. Women provide detailed information through a web-based system at enrollment, monthly during pregnancy, and at pregnancy end, with additional follow-up every three months until the infant reaches 12 months. Researchers collect data on COVID-19 symptoms, treatments, obstetric and neonatal outcomes, and infant development milestones. Medical records are also requested to verify reported information. The primary outcomes measured include obstetric results, neonatal health, infant weight, height, and developmental milestones at one year. Confidentiality and participant anonymity are strictly maintained throughout the study.

COVID-19 International Drug Pregnancy Registry