COVID-19 International Drug Pregnancy Registry

This study is an international registry looking at the effects of COVID-19 treatments on pregnant women and their babies. Researchers want to understand how antiviral agents and monoclonal antibodies, used to treat mild to severe COVID-19 during pregnancy, impact mothers and their infants. They will track outcomes like complications during pregnancy (obstetric outcomes), issues with the newborn (neonatal outcomes), and the baby's weight for up to one year after birth. You may be able to join if you are a woman aged 18 to 50, are pregnant or recently pregnant (within 30 days after delivery), had mild to severe COVID-19 during pregnancy, and were treated with one of these medications. The study aims to enroll 2000 participants.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 2000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your obstetric, neonatal, and infant outcomes will be measured for up to one year after birth.

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NCT05013632

COVID-19 International Drug Pregnancy Registry

Recruiting
Not specifiedAges 18–50Observational
Pregistry
~2,000 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:Antiviral AgentsMonoclonal antibody

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Obstetric outcomes
Measured over 1 year
+4 more outcomes measured
Covid19
1 sites across 1 states
California1
  • Cheryl Renz, MD · PRINCIPAL_INVESTIGATOR · Pregistry

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Eligibility criteria

Inclusion

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"
  • Obstetric outcomes1 year

    Number of pregnant women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and number of pregnant women in the reference cohorts who experience spontaneous abortion, intrauterine growth restriction, gestational diabetes, gestational hypertension, postpartum hemorrhage, Caesarean delivery.

  • Neonatal outcomes1 year

    Number of newborns of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and number of newborns of pregnant women in the reference cohorts who experience major congenital malformations, low birth weight, small for gestational age, neonatal infections, stillbirth, neonatal death, preterm birth.

  • Infant weight1 year

    Change in weight from birth to 3, 6, 9, and 12 months of age among newborns of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and among newborns of pregnant women in the reference cohorts.

  • Infant developmental milestones1 year

    Change in developmental milestones from baseline at 6, 9, and 12 months based on the tool Caregiver Reported Early Development Instruments among the offspring of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and among the offspring of pregnant women in the reference cohorts.

  • Infant height1 year

    Change in length from birth to 3, 6, 9, and 12 months of age among newborns of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and among newborns of pregnant women in the reference cohorts.