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

Stopped early · Phase 1

Conditions studied: COVID-19

In brief

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).

Key facts

Study ID

NCT05386472

Run by

Pfizer

People needed

25

Starts

2022-06-22

Expected to finish

2025-05-12

Last updated by the study team

2025-07-29

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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