The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations.
Diego F Wyszynski, Aris T Papageorghiou, Cheryl Renz...
https://pubmed.ncbi.nlm.nih.gov/37973784Actively Recruiting
Age: 18Years - 50Years
FEMALE
ID05013632
COVID-19 International Drug Pregnancy Registry (COVID-PR)
Led by Pregistry · Updated on 2025-09-26
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 infant's 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.
CONDITIONS
Brief Title
COVID-19 International Drug Pregnancy Registry
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant or recently pregnant (up to 30 days after pregnancy ends) at enrollment
- Age 18 years or older at enrollment
- Diagnosed with mild to severe COVID-19 during pregnancy
- Treated with at least one monoclonal antibody or antiviral drug for COVID-19 during pregnancy, or hospitalized for COVID-19 without receiving specific pharmacological treatment
- Resident of a country where study approval or clearance is obtained
- Signed informed consent and completed baseline medication module
You will not qualify if you...
- Younger than 18 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Enrollment can occur during pregnancy or up to 30 days after pregnancy ends via a website.
Monitoring
Duration - From enrollment until the end of pregnancy
Participants provide monthly pregnancy information during pregnancy and birth information if enrolled after pregnancy. Data on COVID-19 symptoms, treatments, and pregnancy outcomes are collected.
Monthly data collection during pregnancy and at end of pregnancy
Long-term Monitoring
Duration - Up to 12 months after birth
Participants provide data on liveborn infants every three months until the infant reaches 12 months of age, including developmental milestones, weight, and height.
Quarterly data collection visits for up to 12 months after birth
Trial Site Locations
Total: 1 location
1
Pregistry
Los Angeles, California, United States, 90045
Actively Recruiting
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Research Team
C
Cheryl Renz, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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