GSK Pregnancy Registries

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:

  • Voluntary participant registration
  • Willing to complete the initial screening questionnaire
  • Completion of monthly web-based follow-up questionnaires before and after delivery, as well as one phone interview up to the infant’s one year of age

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:

  • 18 years of age or older at the time of enrolment (includes patients that may have received Sotrovimab at the age of 17 but are 18 by the time of enrolment)
  • Currently pregnant or given birth within 30 days
  • Consent provided by the pregnant woman for her participation
  • Residing in any country where Sotrovimab is marketed
  • Received at least one dose of treatment for COVID-19 during pregnancy in a hospital or clinic
  • Able to read and understand the online instructions, be willing to sign the informed consent and to enter the answers to some basic questions about your health

Contact Information:

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:

Exposed cohort 200
Active comparator cohort 200
Unexposed comparator cohort 200

Study Start Date: November 2021

Estimated Primary Completion date: December 2026

Estimated Completion date: January 2027

Additional information:

  • https://covid-pr.pregistry.com/Treatment/Sotrovimab

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