Head Safety Science, Epidemiology GlaxoSmithKline Cary, United States
Background: Sotrovimab is used for the treatment of mild-to-moderate COVID-19 in patients are at high risk for progression to severe COVID-19. Pregnancy is one of the underlying conditions that has been associated with higher risk for severe COVID-19. As part of a commitment to monitor sotrovimab’s safety, the COVID-PR was used to collect clinical evidence on usage and safety of sotrovimab in pregnancy.
Objectives: To describe characteristics of pregnant people with COVID-19 treated with sotrovimab
Methods: The COVID-PR is an international, non-interventional, post-marketing cohort study of COVID-19 therapeutics. The study population includes pregnant or recently pregnant people aged ≥18 years, treated with any COVID-19 therapeutic during pregnancy. Self-reported information is collected on COVID-19 symptoms as well as sociodemographic and health characteristics. The study also collects information on obstetric, neonatal, and infant outcomes with a follow-up period of 12 months. In addition, a web-based data collection system requests anonymized medical records. This registry-based study began collecting exposure data on sotrovimab in December 2021.
Results: As of 30 November 2022, 38 study participants treated with sotrovimab during pregnancy were enrolled in the COVID-PR study. The majority were recruited during Omicron variant period. To date, 12 participants reported live births and are under ongoing follow-up. The majority were exposed to sotrovimab in the second trimester (n=17). Most participants were from the United States; participants also enrolled from Germany and Canada. The median age range was 32.5 years (Range: 24-40). Of the 34 participants with reported pre-pregnancy BMI, the majority were overweight or obese with a BMI of 25 or over (n=19). Of the 28 participants with data available, 14 participants reported having at least one medical condition at the onset of pregnancy, with asthma and polycystic ovary syndrome (PCOS) being the most frequently reported conditions.
Conclusions: In addition to pregnancy, many of the people that were treated with sotrovimab also had other underlying medical conditions associated with higher risk for severe COVID-19. Current data is limited to draw any conclusions regarding sotrovimab in pregnancy. The COVID-PR continues to monitor obstetric, neonatal, and infant safety outcomes through 12 months after birth in women treated with sotrovimab.
