COVID-19 International Drug Pregnancy Registry

Launched by PREGISTRY · Aug 17, 2021

Keywords

ClinConnect Summary

The COVID-19 International Drug Pregnancy Registry (COVID-PR) is a clinical trial that aims to study the effects of certain medications on pregnant women who have COVID-19. Specifically, it looks at how treatments like monoclonal antibodies and antiviral drugs impact the health of both the mother and her baby from the start of the pregnancy to childbirth. The study is important for understanding the safety and outcomes of these treatments during pregnancy.

To participate in this trial, women must be at least 18 years old and either currently pregnant or have been pregnant within the last 30 days. They should have experienced mild to severe COVID-19 during their pregnancy and have received specific treatments for it, or they must have been hospitalized without receiving those treatments. Participants will need to sign a consent form and provide some information about their medication use during pregnancy. This study is currently recruiting participants and is taking place in locations approved by ethics committees to ensure the safety and rights of those involved.

Gender

FEMALE

Eligibility 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