A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19

Last updated: July 24, 2025
Sponsor: Pfizer
Overall Status: Terminated

Phase

1

Condition

Covid-19

Treatment

nirmatrelvir

ritonavir

Clinical Study ID

NCT05386472
C4671035
  • Ages 18-50
  • Female

Study Summary

The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild or moderate COVID-19.

This study is seeking participants who:

  • are expecting a healthy baby and are in their second or third trimester pregnancy and have mild or moderate COVID-19

  • are not pregnant and have mild or moderate COVID-19.

All participants in this study will take Paxlovid by mouth every 12 hours for 5 days. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe.

All participants will take part in this study for at least 34 days; pregnant participants will take part until their delivery, so that the study duration may be up to 6 months, depending on their delivery date.

During this time, participants will have 7to 8 visits and, if pregnant, a visit at delivery. Around 2 to 3 visits and the delivery visit will be done in person (at the clinic or at the participant's home). The other 5 visits may be done over the phone, unless in-person visit is necessary as decided by the doctor. Blood samples will be collected on the first 4 to 5 study visits (and at other study visits, if necessary).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All cohorts: Mild-to-moderate COVID-19 infection confirmed in sample collected ≤5days prior to enrollment; onset within 5 days prior to enrollment and presence of ≥1sign/symptom on the day of enrollment.

  • Cohorts 1&2: Expecting single baby; Pregnant in 2nd trimester, 14 0/7 to 27 6/7weeks of gestational age (Cohort 1) or 3rd trimester, ≥28 0/7 and ≤34 6/7 weeks ofgestational age (Cohort 2), by ultrasound.

  • All cohorts: Otherwise healthy participants who are determined by medical history,physical examination, and clinical judgment to be appropriate for inclusion in thestudy

Exclusion

Exclusion Criteria:

  • All cohorts: Current need for hospitalization or anticipated need forhospitalization in the clinical opinion of the site investigator.

  • Cohorts 1&2: Prior/current major condition or illness of mother/fetus substantiallyincreasing risk of study participation/completion or impacting pregnancy/fetaloutcomes in investigator's judgement.

  • All cohorts: Current use of any medications that are highly dependent on CYP3A4 forclearance, and which are contraindicated in combination with nirmatrelvir/ritonavir.

  • All cohorts: Has received or is expected to receive monoclonal antibody treatment,convalescent COVID-19 plasma, or anti-viral treatment (eg, molnupiravir) for thecurrent SARSCoV-2 infection.

  • All cohorts: Participants with moderate to severe kidney impairment

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: nirmatrelvir
Phase: 1
Study Start date:
June 22, 2022
Estimated Completion Date:
May 12, 2025

Connect with a study center

  • University of Alabama at Birmingham Women & Infant Center

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Alabama at Birmingham/Center for Women's Reproductive Health

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Abby's Research institute

    Phoenix, Arizona 85031
    United States

    Site Not Available

  • Chemidox Clinical Trials

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Women and Infant Pavilion, Antelope Valley Hospital

    Lancaster, California 93534
    United States

    Site Not Available

  • Matrix Clinical Research

    Los Angeles, California 90057
    United States

    Site Not Available

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida 33157
    United States

    Site Not Available

  • Omega Research Debary

    DeBary, Florida 32713
    United States

    Site Not Available

  • Vital Pharma Research

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Suncoast Research Group

    Miami, Florida 33135
    United States

    Site Not Available

  • Omega Research Orlando

    Orlando, Florida 32808
    United States

    Site Not Available

  • Santos Research Center

    Tampa, Florida 33615
    United States

    Site Not Available

  • Clinical Research Prime

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Clinical Research Prime Rexburg

    Rexburg, Idaho 83440
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Michigan Center of Medical Research (MICHMER)

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Boeson Research (GTF)

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Great Falls OB-GYN Associates

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Boeson Research

    Missoula, Montana 59804
    United States

    Site Not Available

  • Boeson Research MSO

    Missoula, Montana 59804
    United States

    Site Not Available

  • Origin Health

    Missoula, Montana 59804
    United States

    Site Not Available

  • Unified Women's Clinical Research (Administrative Office)

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Unified Women's Clinical Research - Lyndhurst

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • St. David's Medical Center

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Tekton Research, Inc.

    Austin, Texas 78705
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • Maximos Ob/Gyn

    League City, Texas 77573
    United States

    Site Not Available

  • The University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • UT Health Medical Arts and Research Center (MARC)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Utah Clinical Neuroscience Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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