Back to resultsA Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
Primary Purpose
COVID-19
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
nirmatrelvir
ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), Pregnancy, Paxlovid, Nirmatrelvir
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham Women & Infant CenterRecruiting
- University of Alabama at Birmingham/Center for Women's Reproductive HealthRecruiting
- Abby's Research instituteRecruiting
- Chemidox Clinical TrialsRecruiting
- Women and Infant Pavilion, Antelope Valley HospitalRecruiting
- Matrix Clinical Research
- Beautiful Minds Clinical Research Center
- Omega Research Debary
- Vital Pharma Research
- Suncoast Research Group
- Omega Research Orlando
- Santos Research Center
- Clinical Research PrimeRecruiting
- Clinical Research Prime RexburgRecruiting
- Michigan Center of Medical Research (MICHMER)Recruiting
- Boeson Research (GTF)
- Great Falls OB-GYN Associates
- Boeson Research MSO
- Origin Health
- Unified Women's Clinical Research (Administrative Office)Recruiting
- Unified Women's Clinical Research - LyndhurstRecruiting
- St. David's Medical CenterRecruiting
- Tekton Research, Inc.Recruiting
- University of Texas Medical BranchRecruiting
- Maximos Ob/GynRecruiting
- University of UtahRecruiting
- University of UtahRecruiting
- University of Utah Clinical Neuroscience CenterRecruiting
- University of Utah HospitalRecruiting
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Pregnant women in their second trimester
Pregnant women in their third trimester
Non-pregnant women
Outcomes
Primary Outcome Measures
Apparent Oral Clearance (CL/F)
Apparent Volume of Distribution (Vz/F)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Maximum Observed Plasma Concentration (Cmax)
Plasma Decay Half-Life (t1/2)
Observed Plasma Trough Concentration (Ctrough)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of TEAEs, SAEs, and AEs leading to discontinuations
Secondary Outcome Measures
Number of participants with delivery at medical facility
Number of participants with delivery at home
Number of participants with delivery at other location
Number of participants with caesarean section delivery
Number of participants with vaginal delivery
Number of participants with complications during delivery
Number of full-term live deliveries
Number of premature live deliveries
Number of participants with stillbirths
Number of participants with spontaneous abortions
Number of participants with induced/elective abortions
Number of participants with unknown delivery
Number of aborted or stillborn fetuses with abnormal findings upon gross visual inspection
Gestational age of newborn infants
Number of neonates with congenital malformation/anomaly or other neonatal problem
Body weight of newborn infants
Body length of newborn infants
Head circumference of newborn infants
Incidence of SAEs in newborn infants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05386472
Brief Title
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
Official Title
A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF ORALLY ADMINISTERED NIRMATRELVIR/RITONAVIR IN PREGNANT WOMEN WITH MILD-TO-MODERATE COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
March 7, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), Pregnancy, Paxlovid, Nirmatrelvir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
(Open Label)
Allocation
Non-Randomized
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Pregnant women in their second trimester
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Pregnant women in their third trimester
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Non-pregnant women
Intervention Type
Drug
Intervention Name(s)
nirmatrelvir
Other Intervention Name(s)
PF-07321332
Intervention Description
Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
Intervention Type
Drug
Intervention Name(s)
ritonavir
Intervention Description
Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)
Primary Outcome Measure Information:
Title
Apparent Oral Clearance (CL/F)
Time Frame
Day 1: 1-3 hour post-dose; Day 3: 4-8 hour post-dose; Day 4: 8 to less than 12 hour post dose; Day 5: 2-4 hour, 6-8 hour, 10 to less than 12 hour post dose.
Title
Apparent Volume of Distribution (Vz/F)
Time Frame
Day 1: 1-3 hour post-dose; Day 3: 4-8 hour post-dose; Day 4: 8 to less than 12 hour post dose; Day 5: 2-4 hour, 6-8 hour, 10 to less than 12 hour post dose.
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time Frame
Day 1: 1-3 hour post-dose; Day 3: 4-8 hour post-dose; Day 4: 8 to less than 12 hour post dose; Day 5: 2-4 hour, 6-8 hour, 10 to less than 12 hour post dose.
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Day 1: 1-3 hour post-dose; Day 3: 4-8 hour post-dose; Day 4: 8 to less than 12 hour post dose; Day 5: 2-4 hour, 6-8 hour, 10 to less than 12 hour post dose.
Title
Plasma Decay Half-Life (t1/2)
Time Frame
Day 1: 1-3 hour post-dose; Day 3: 4-8 hour post-dose; Day 4: 8 to less than 12 hour post dose; Day 5: 2-4 hour, 6-8 hour, 10 to less than 12 hour post dose.
Title
Observed Plasma Trough Concentration (Ctrough)
Time Frame
Day 1: 1-3 hour post-dose; Day 3: 4-8 hour post-dose; Day 4: 8 to less than 12 hour post dose; Day 5: 2-4 hour, 6-8 hour, 10 to less than 12 hour post dose.
Title
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame
Baseline up through Day 34
Title
Incidence of TEAEs, SAEs, and AEs leading to discontinuations
Time Frame
Baseline up through end of treatment (Day 5/Day 6)
Secondary Outcome Measure Information:
Title
Number of participants with delivery at medical facility
Time Frame
At delivery of the baby
Title
Number of participants with delivery at home
Time Frame
At delivery of the baby
Title
Number of participants with delivery at other location
Time Frame
At delivery of the baby
Title
Number of participants with caesarean section delivery
Time Frame
At delivery of the baby
Title
Number of participants with vaginal delivery
Time Frame
At delivery of the baby
Title
Number of participants with complications during delivery
Time Frame
At delivery of the baby
Title
Number of full-term live deliveries
Time Frame
At delivery of the baby
Title
Number of premature live deliveries
Time Frame
At delivery of the baby
Title
Number of participants with stillbirths
Time Frame
At delivery of the baby
Title
Number of participants with spontaneous abortions
Time Frame
At delivery of the baby
Title
Number of participants with induced/elective abortions
Time Frame
At delivery of the baby
Title
Number of participants with unknown delivery
Time Frame
At delivery of the baby
Title
Number of aborted or stillborn fetuses with abnormal findings upon gross visual inspection
Time Frame
At delivery of the baby
Title
Gestational age of newborn infants
Time Frame
At birth
Title
Number of neonates with congenital malformation/anomaly or other neonatal problem
Time Frame
At birth
Title
Body weight of newborn infants
Time Frame
At birth
Title
Body length of newborn infants
Time Frame
At birth
Title
Head circumference of newborn infants
Time Frame
At birth
Title
Incidence of SAEs in newborn infants
Time Frame
Birth through 24 hours after birth or until Study Day 34 (whichever is later)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant and non-pregnant females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Women & Infant Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Alabama at Birmingham/Center for Women's Reproductive Health
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Abby's Research institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85031
Country
United States
Individual Site Status
Recruiting
Facility Name
Chemidox Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Women and Infant Pavilion, Antelope Valley Hospital
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Matrix Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Beautiful Minds Clinical Research Center
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omega Research Debary
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Terminated
Facility Name
Vital Pharma Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Omega Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Terminated
Facility Name
Santos Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Prime Rexburg
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Center of Medical Research (MICHMER)
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research (GTF)
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Great Falls OB-GYN Associates
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Boeson Research MSO
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Terminated
Facility Name
Origin Health
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Terminated
Facility Name
Unified Women's Clinical Research (Administrative Office)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Unified Women's Clinical Research - Lyndhurst
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Name
Maximos Ob/Gyn
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah Clinical Neuroscience Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4671035
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
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