The purpose of this clinical trial is to learn about how study medicine (Paxlovid, whichcontains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well asits safety, and the extent to which side effects can be tolerated for treatment ofpregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild ormoderate 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. Wewill study the experiences of people receiving the study medicine. This will help usdecide if the study medicine is safe.All participants will take part in this study for at least 34 days; pregnant participantswill 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 atdelivery. Around 2 to 3 visits and the delivery visit will be done in person (at theclinic 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 becollected on the first 4 to 5 study visits (and at other study visits, if necessary).
Not Provided
Drug: nirmatrelvir
Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
Other Name: PF-07321332
Drug: ritonavir
Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)
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
University of Alabama at Birmingham Women & Infant Center
Birmingham, Alabama, United States
University of Alabama at Birmingham/Center for Women's Reproductive Health
Birmingham, Alabama, United States
Abby's Research institute
Phoenix, Arizona, United States
Chemidox Clinical Trials
Lancaster, California, United States
Women and Infant Pavilion, Antelope Valley Hospital
Lancaster, California, United States
Matrix Clinical Research
Los Angeles, California, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States
Omega Research Debary
DeBary, Florida, United States
Vital Pharma Research
Hialeah, Florida, United States
Suncoast Research Group
Miami, 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
Clinical Research Prime Rexburg
Rexburg, Idaho, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Michigan Center of Medical Research (MICHMER)
Farmington Hills, Michigan, United States
Boeson Research (GTF)
Great Falls, Montana, United States
Great Falls OB-GYN Associates
Great Falls, Montana, United States
Boeson Research MSO
Missoula, Montana, United States
Origin Health
Missoula, Montana, United States
Unified Women's Clinical Research (Administrative Office)
Winston-Salem, North Carolina, United States
Unified Women's Clinical Research - Lyndhurst
Winston-Salem, North Carolina, United States
St. David's Medical Center
Austin, Texas, United States
Tekton Research, Inc.
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Maximos Ob/Gyn
League City, Texas, United States
The University of Texas Health Science Center
San Antonio, Texas, United States
UT Health Medical Arts and Research Center (MARC)
San Antonio, 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
University of Utah
Salt Lake City, Utah, United States
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer