Clincosm LogoSign in Get a demo

A Study to Learn About the Study Medicine (Called Nirmatrelvir/Ritonavir) in Pregnant Women With Mild or Moderate COVID-19.

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05386472
Collaborator
(none)
45
Enrollment
19
Locations
3
Arms
13.7
Anticipated Duration (Months)
2.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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 pregnant 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 (10 doses total). We will examine the experiences of people receiving the study medicine. This will help us determine 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 7-8 visits and, if pregnant, a visit at delivery. 2-3 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 an in-person visit is necessary as determined by the investigator. Blood samples will be collected on the first 4-5 study visits (and at other study visits, if necessary). Some blood samples may be taken by participants themselves.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
(Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 22, 2022
Anticipated Primary Completion Date :
Jan 27, 2023
Anticipated Study Completion Date :
Aug 12, 2023

Arms and Interventions

Arm Intervention/Treatment
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)

    Outcome Measures

    Primary Outcome Measures

    1. Apparent Oral Clearance (CL/F) [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.]

    2. Apparent Volume of Distribution (Vz/F) [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.]

    3. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [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.]

    4. Maximum Observed Plasma Concentration (Cmax) [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.]

    5. Plasma Decay Half-Life (t1/2) [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.]

    6. Observed Plasma Trough Concentration (Ctrough) [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.]

    7. Incidence of Treatment Emergent Adverse Events (TEAEs) [Baseline up through Day 34]

    8. Incidence of TEAEs, SAEs, and AEs leading to discontinuations [Baseline up through end of treatment (Day 5/Day 6)]

    Secondary Outcome Measures

    1. Number of participants with delivery at medical facility [At delivery of the baby]

    2. Number of participants with delivery at home [At delivery of the baby]

    3. Number of participants with delivery at other location [At delivery of the baby]

    4. Number of participants with caesarean section delivery [At delivery of the baby]

    5. Number of participants with vaginal delivery [At delivery of the baby]

    6. Number of participants with complications during delivery [At delivery of the baby]

    7. Number of full-term live deliveries [At delivery of the baby]

    8. Number of premature live deliveries [At delivery of the baby]

    9. Number of participants with stillbirths [At delivery of the baby]

    10. Number of participants with spontaneous abortions [At delivery of the baby]

    11. Number of participants with induced/elective abortions [At delivery of the baby]

    12. Number of participants with unknown delivery [At delivery of the baby]

    13. Number of aborted or stillborn fetuses with abnormal findings upon gross visual inspection [At delivery of the baby]

    14. Gestational age of newborn infants [At birth]

    15. Number of neonates with congenital malformation/anomaly or other neonatal problem [At birth]

    16. Body weight of newborn infants [At birth]

    17. Body length of newborn infants [At birth]

    18. Head circumference of newborn infants [At birth]

    19. Incidence of SAEs in newborn infants [Birth through 24 hours after birth or until Study Day 34 (whichever is later)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chemidox Clinical Trials Lancaster California United States 93534
    2 Women and Infant Pavilion, Antelope Valley Hospital Lancaster California United States 93534
    3 Matrix Clinical Research Los Angeles California United States 90057
    4 Beautiful Minds Clinical Research Center Cutler Bay Florida United States 33157
    5 Omega Research Debary DeBary Florida United States 32713
    6 Vital Pharma Research Hialeah Florida United States 33016
    7 Suncoast Research Group Miami Florida United States 33135
    8 Omega Research Orlando Orlando Florida United States 32808
    9 Santos Research Center Tampa Florida United States 33615
    10 Clinical Research Prime Idaho Falls Idaho United States 83404
    11 Clinical Research Prime Rexburg Rexburg Idaho United States 83440
    12 Michigan Center of Medical Research (MICHMER) Farmington Hills Michigan United States 48334
    13 Boeson Research Missoula Montana United States 59804
    14 Origin Health Missoula Montana United States 59804
    15 Unified Women's Clinical Research (Administrative Office) Winston-Salem North Carolina United States 27103
    16 Unified Women's Clinical Research - Lyndhurst Winston-Salem North Carolina United States 27103
    17 St. David's Medical Center Austin Texas United States 78705
    18 Tekton Research, Inc. Austin Texas United States 78705
    19 University of Texas Medical Branch Galveston Texas United States 77555

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05386472
    Other Study ID Numbers:
    • C4671035
    First Posted:
    May 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pfizer
    Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
    Pregnancy
    Paxlovid
    Nirmatrelvir
    Additional relevant MeSH terms:
    COVID-19
    Ritonavir

    Study Results

    No Results Posted as of Aug 23, 2022