COVID-19 International Drug Pregnancy Registry
COVID-19 International Drug Pregnancy Registry (COVID-PR)
Pregistry
2,000 participants
Dec 1, 2021
OBSERVATIONAL
Summary
The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.
Eligibility
Inclusion Criteria8
- 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 Criteria1
- ● <18 years of age
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Antiviral medications indicated for the treatment of mild to severe COVID-19
Monoclonal antibodies indicated for the treatment of mild to severe COVID-19
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05013632