Sotrovimab (Xevudy®) Pregnancy Registry The COVID-19 International Drug Pregnancy Registry (COVID-PR) is evaluating the safety of in-hospital or outpatient medical treatment, including Sotrovimab, for mild to severe COVID-19 among pregnant women. The registry prospectively collects information on pregnant women 18 years of age or older who receive treatment for mild to severe COVID-19 at any time during pregnancy or within 90 days prior to the first day of the last menstrual period. The objective of the COVID-PR is to evaluate obstetric, neonatal, and infant outcomes. It includes maternal and offspring follow-up until the infant’s one year of age. Sotrovimab use in COVID-PR will be examined on a yearly basis. Obstetric, neonatal, and infant outcomes will be assessed on an ongoing basis as data becomes available. Registration and participation for the registry can be completed via the website. An eligible person may enroll at any time during pregnancy and up to 30 days after the end of pregnancy. In addition to self-reported information, the web data collection system provides instruction on how participants can upload additional information received from their health care providers. Patient Participation Involves:
Eligibility Criteria: The registry population consists of pregnant women who were treated with in-hospital or outpatient medication, including Sotrovimab, for mild to severe COVID-19 at any time during pregnancy or within 90 days prior to the first day of the last menstrual period. To be eligible to register in the COVID-PR, a person must be:
Contact Information: The study is conducted by : Pregistry, LLC Email: COVID-PR@pregistry.com Enrollment: Pregnant and recently pregnant individuals may go to https://covid-pr.pregistry.com enrol or call 1-800-616-3791 to obtain information about the registry. Target Enrolment:
Study Start Date: November 2021 Estimated Primary Completion date: December 2026 Estimated Completion date: January 2027 Additional information: Complete Prescribing Information is provided in Adobe's Portable Document Format (PDF). To view these documents, you will need Adobe Acrobat Reader; if you do not have it, follow the link below to download a copy. If you are unable to or do not wish to download Acrobat Reader, but still wish to receive complete Prescribing Information, please click here. |
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