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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
(Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		Pregnant women in their second trimester
  • Drug: nirmatrelvir
    Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
    Other names:
    • PF-07321332
  • Drug: ritonavir
    Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)
Experimental
Cohort 2 		Pregnant women in their third trimester
  • Drug: nirmatrelvir
    Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
    Other names:
    • PF-07321332
  • Drug: ritonavir
    Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)
Experimental
Cohort 3 		Non-pregnant women
  • Drug: nirmatrelvir
    Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
    Other names:
    • PF-07321332
  • Drug: ritonavir
    Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)

Recruiting Locations

University of Alabama at Birmingham Women & Infant Center
Birmingham, Alabama 35233

University of Alabama at Birmingham/Center for Women's Reproductive Health
Birmingham, Alabama 35233

Abby's Research institute
Phoenix, Arizona 85031

Chemidox Clinical Trials
Lancaster, California 93534

Women and Infant Pavilion, Antelope Valley Hospital
Lancaster, California 93534

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Michigan Center of Medical Research (MICHMER)
Farmington Hills, Michigan 48334

Unified Women's Clinical Research (Administrative Office)
Winston-Salem, North Carolina 27103

Unified Women's Clinical Research - Lyndhurst
Winston-Salem, North Carolina 27103

St. David's Medical Center
Austin, Texas 78705

Tekton Research, Inc.
Austin, Texas 78705

University of Texas Medical Branch
Galveston, Texas 77555

University of Utah
Salt Lake City, Utah 84108

University of Utah
Salt Lake City, Utah 84112

University of Utah Clinical Neuroscience Center
Salt Lake City, Utah 84132

University of Utah Hospital
Salt Lake City, Utah 84132

University of Utah
Salt Lake City, Utah 84132

More Details

NCT ID
NCT05386472
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.