COVID-19 International Drug Pregnancy Registry

NCT05013632 | Recruiting FDA Drug

• 1 other identifier: PR005
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (5)

• Obstetric outcomes

  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.

  1 year

• Neonatal outcomes

  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.

  1 year

• Infant weight

  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.

  1 year

• Infant developmental milestones

  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.

  1 year

• Infant height

  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.

  1 year

Study Arms (3)

Exposed pregnant women

Pregnant or recently pregnant women 18 years of age and older treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 at any time during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.

Drug: Antiviral Agents; Drug: Monoclonal antibody

Active comparator pregnant women

Pregnant women treated with another therapy for mild, moderate, or severe COVID-19

Unexposed pregnant women

Pregnant women hospitalized but not treated with a medication specifically indicated for the treatment of mild, moderate, or severe COVID-19

Interventions

Antiviral Agents DRUG

Antiviral medications indicated for the treatment of mild to severe COVID-19

Also known as: Veklury (remdesivir), Lagevrio (molnupiravir)

Exposed pregnant women

Monoclonal antibody DRUG

Monoclonal antibodies indicated for the treatment of mild to severe COVID-19

Also known as: REGEN-COV (casirivimab/imdevimab), Xevudy (sotrovimab)

Exposed pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Persons assigned gender female at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The exposed study population consists of pregnant or recently pregnant women 18 years of age and older treated with at least one dose of a monoclonal antibody or antiviral drug indicated for COVID-19 from first day of the LMP to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP. The reference groups include pregnant women not exposed to monoclonal antibodies or antiviral drugs and treated with another therapy for mild, moderate, or severe COVID-19 (active comparator) and women who experienced COVID-19 during pregnancy and were hospitalized but were not treated with a medication specifically indicated for mild, moderate, or severe COVID-19 (unexposed comparator), matched by calendar time, country of residence, gestational timing at the time of COVID-19 infection (± 2 weeks), and severity of COVID-19.

You may qualify if:

• 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"

You may not qualify if:

• ● \<18 years of age

Sponsors & Collaborators

• Pregistry: lead

Study Sites (1)

Pregistry

Los Angeles, California, 90045, United States

RECRUITING

Related Publications (1)

• Wyszynski DF, Papageorghiou AT, Renz C, Metz TD, Hernandez-Diaz S. The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations. Drug Saf. 2024 Mar;47(3):195-204. doi: 10.1007/s40264-023-01377-2. Epub 2023 Nov 16.

  PMID: 37973784 DERIVED

Related Links

• COVID-19 International Drug Pregnancy Registry (COVID-PR)

MeSH Terms

Conditions

COVID-19

Interventions

Antiviral Agents; remdesivir; molnupiravir; Antibodies, Monoclonal; casirivimab and imdevimab drug combination; casirivimab; imdevimab; sotrovimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Cheryl Renz, MD

  Pregistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Renz, MD

CONTACT

18006163791; covid-pr@pregistry.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 19, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)