Status:
TERMINATED
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
Lead Sponsor:
Pfizer
Conditions:
COVID-19
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief 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 ex...
Eligibility Criteria
Inclusion
- All cohorts: Mild-to-moderate COVID-19 infection confirmed in sample collected ≤5 days prior to enrollment; onset within 5 days prior to enrollment and presence of ≥1 sign/symptom on the day of enrollment.
- 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
- All cohorts: Current need for hospitalization or anticipated need for hospitalization in the clinical opinion of the site investigator.
- 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
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05386472
Start Date
June 22 2022
End Date
May 12 2025
Last Update
July 29 2025
Active Locations (13)
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1
University of Alabama at Birmingham/Center for Women's Reproductive Health
Birmingham, Alabama, United States, 35233
2
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States, 33157
3
Omega Research Debary
DeBary, Florida, United States, 32713
4
Omega Research Orlando
Orlando, Florida, United States, 32808