Registry to evaluate pregnancy outcomes in women treated for COVID-19
COVID-19 International Drug Pregnancy Registry (COVID-PR)
This study is trying to see how treatments for COVID-19, like certain medications, affect the health of pregnant women and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Pregistry Industry-sponsored |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05013632 on ClinicalTrials.gov |
What this trial studies
The COVID-19 International Drug Pregnancy Registry aims to assess the effects of monoclonal antibodies and antiviral drugs on obstetric, neonatal, and infant outcomes in pregnant women treated for COVID-19. This observational study will collect data from women from the first day of their last menstrual period until the end of their pregnancy, including a 90-day exposure period for monoclonal antibodies. The study will focus on various outcomes such as spontaneous abortion, congenital malformations, and developmental milestones in infants. By gathering this data, the registry seeks to fill the knowledge gap regarding the safety of these treatments during pregnancy.
Who should consider this trial
Good fit: Ideal candidates include pregnant or recently pregnant women aged 18 and older who have experienced mild to severe COVID-19 and have been treated with specific medications.
Not a fit: Patients who are under 18 years of age or who have not received pharmacological treatment for COVID-19 during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide critical safety data that informs treatment decisions for pregnant women with COVID-19.
How similar studies have performed: While there have been studies on COVID-19 treatments, this registry approach focusing specifically on pregnancy outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant or recently pregnant (up to 30 days after the end of pregnancy) at time of enrollment * Age ≥18 years at time of enrollment * With mild to severe COVID-19 during pregnancy * Either * Treated for COVID-19 with at least one of the medications included in Table 1 during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP or * Hospitalized and did not receive any pharmacological treatment specifically indicated for mild, moderate, or severe COVID-19 during pregnancy * Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study * Signed the informed consent form and submitted the baseline module "COVID-19 Medications During This Pregnancy" Exclusion Criteria: ● \<18 years of age
Where this trial is running
Los Angeles, California
- Pregistry — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Cheryl Renz, MD — Pregistry
- Study coordinator: Cheryl Renz, MD
- Email: covid-pr@pregistry.com
- Phone: 18006163791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.