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

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ClinicalTrials.gov Identifier: NCT05013632
Recruitment Status : Recruiting
First Posted : August 19, 2021
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Pregistry

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.

Condition or disease Intervention/treatment
Covid19 Drug: Antiviral Agents Drug: Monoclonal antibody

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 International Drug Pregnancy Registry (COVID-PR)
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : September 30, 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Antiviral medications indicated for the treatment of mild to severe COVID-19
Other Names:
  • Veklury (remdesivir)
  • Lagevrio (molnupiravir)

Drug: Monoclonal antibody
Monoclonal antibodies indicated for the treatment of mild to severe COVID-19
Other Names:
  • REGEN-COV (casirivimab/imdevimab)
  • Xevudy (sotrovimab)

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



Primary Outcome Measures :
  1. Obstetric outcomes [ Time Frame: 1 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.

  2. Neonatal outcomes [ Time Frame: 1 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.

  3. Infant weight [ Time Frame: 1 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.

  4. Infant developmental milestones [ Time Frame: 1 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.

  5. Infant height [ Time Frame: 1 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Persons assigned gender female at birth.
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05013632


Contacts
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Contact: Diego Wyszynski, MD, MHS, PhD 18006163791 covid-pr@pregistry.com

Locations
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United States, California
Pregistry Recruiting
Los Angeles, California, United States, 90045
Contact: Diego Wyszynski, MD, MHS, PhD         
Principal Investigator: Diego Wyszynski, MD, MHS, PhD         
Sponsors and Collaborators
Pregistry
Investigators
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Principal Investigator: Diego Wyszynski, MD, MHS, PhD Pregistry
Additional Information:
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Responsible Party: Pregistry
ClinicalTrials.gov Identifier: NCT05013632    
Other Study ID Numbers: PR005
First Posted: August 19, 2021    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Remdesivir
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antiviral Agents
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action