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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386472
• Other study ID #: C4671035
• Status: Recruiting
• Phase: Phase 1
• Start date: June 22, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: July 1, 2025
• Est. primary completion date: February 5, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• nirmatrelvir
Nirmatrelvir (tablets) administered by mouth every 12 hours for 5 days (10 doses total)
• ritonavir
Ritonavir (capsules) administered by mouth every 12 hours for 5 days (10 doses total)

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	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	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Beautiful Minds Clinical Research Center	Cutler Bay	Florida
United States	Omega Research Debary	DeBary	Florida
United States	Michigan Center of Medical Research (MICHMER)	Farmington Hills	Michigan
United States	University of Texas Medical Branch	Galveston	Texas
United States	Boeson Research (GTF)	Great Falls	Montana
United States	Great Falls OB-GYN Associates	Great Falls	Montana
United States	Vital Pharma Research	Hialeah	Florida
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Chemidox Clinical Trials	Lancaster	California
United States	Women and Infant Pavilion, Antelope Valley Hospital	Lancaster	California
United States	Maximos Ob/Gyn	League City	Texas
United States	Matrix Clinical Research	Los Angeles	California
United States	Suncoast Research Group	Miami	Florida
United States	Boeson Research MSO	Missoula	Montana
United States	Origin Health	Missoula	Montana
United States	Omega Research Orlando	Orlando	Florida
United States	Abby's Research institute	Phoenix	Arizona
United States	Clinical Research Prime Rexburg	Rexburg	Idaho
United States	University of Utah	Salt Lake City	Utah
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 Clinical Neuroscience Center	Salt Lake City	Utah
United States	University of Utah Hospital	Salt Lake City	Utah
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	Santos Research Center	Tampa	Florida
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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs)		Baseline up through Day 34
Primary	Incidence of TEAEs, SAEs, and AEs leading to discontinuations		Baseline up through end of treatment (Day 5/Day 6)
Secondary	Number of participants with delivery at medical facility		At delivery of the baby
Secondary	Number of participants with delivery at home		At delivery of the baby
Secondary	Number of participants with delivery at other location		At delivery of the baby
Secondary	Number of participants with caesarean section delivery		At delivery of the baby
Secondary	Number of participants with vaginal delivery		At delivery of the baby
Secondary	Number of participants with complications during delivery		At delivery of the baby
Secondary	Number of full-term live deliveries		At delivery of the baby
Secondary	Number of premature live deliveries		At delivery of the baby
Secondary	Number of participants with stillbirths		At delivery of the baby
Secondary	Number of participants with spontaneous abortions		At delivery of the baby
Secondary	Number of participants with induced/elective abortions		At delivery of the baby
Secondary	Number of participants with unknown delivery		At delivery of the baby
Secondary	Number of aborted or stillborn fetuses with abnormal findings upon gross visual inspection		At delivery of the baby
Secondary	Gestational age of newborn infants		At birth
Secondary	Number of neonates with congenital malformation/anomaly or other neonatal problem		At birth
Secondary	Body weight of newborn infants		At birth
Secondary	Body length of newborn infants		At birth
Secondary	Head circumference of newborn infants		At birth
Secondary	Incidence of SAEs in newborn infants		Birth through 24 hours after birth or until Study Day 34 (whichever is later)

External Links

•   To obtain contact information for a study center near you, click here.