A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
NCT ID: NCT05386472
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
25 participants
INTERVENTIONAL
2022-06-22
2025-05-12
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Pregnant women in their second trimester
nirmatrelvir
Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
ritonavir
Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)
Cohort 2
Pregnant women in their third trimester
nirmatrelvir
Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
ritonavir
Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)
Cohort 3
Non-pregnant women
nirmatrelvir
Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
ritonavir
Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)
Interventions
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nirmatrelvir
Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
ritonavir
Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cohorts 1\&2: Expecting single baby; Pregnant in 2nd trimester, 14 0/7 to 27 6/7 weeks of gestational age (Cohort 1) or 3rd trimester, ≥28 0/7 and ≤34 6/7 weeks of gestational 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 the study
Exclusion Criteria
* Cohorts 1\&2: Prior/current major condition or illness of mother/fetus substantially increasing risk of study participation/completion or impacting pregnancy/fetal outcomes in investigator's judgement.
* All cohorts: Current use of any medications that are highly dependent on CYP3A4 for clearance, 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 the current SARSCoV-2 infection.
* All cohorts: Participants with moderate to severe kidney impairment
18 Years
50 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham/Center for Women's Reproductive Health
Birmingham, Alabama, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States
Omega Research Debary
DeBary, Florida, United States
Omega Research Orlando
Orlando, Florida, United States
Santos Research Center
Tampa, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Boeson Research MSO
Missoula, Montana, United States
Origin Health
Missoula, Montana, United States
Maximos Ob/Gyn
League City, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Utah Clinical Neuroscience Center
Salt Lake City, Utah, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05386472
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4671035
Identifier Type: -
Identifier Source: org_study_id
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