EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease

January 30, 2024 updated by: Pfizer

A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE

The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19).

The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.

Study Overview

Status

Suspended

Conditions

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Gorna Oryahovitsa, Bulgaria, 5100
        • МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa
      • Lom, Bulgaria, 3600
        • Diagnostic-Consultative Center I Lom EOOD
      • Plovdiv, Bulgaria, 4000
        • DCC Sveti Georgi EOOD
      • Ruse, Bulgaria, 7002
        • "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
      • Sevlievo, Bulgaria, 5400
        • Medical Center-1-Sevlievo EOOD
      • Sofia, Bulgaria, 1431
        • DCC "Alexandrovska"
      • Vratsa, Bulgaria, 3000
        • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
      • Debrecen, Hungary, 04032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Klinikai Kozpont
    • Heves
      • Eger, Heves, Hungary, 3300
        • Markhot Ferenc Oktatokorhaz es Rendelointezet
      • Aguascalientes, Mexico, 20259
        • Centenario Hospital Miguel Hidalgo
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazon
      • Veracruz, Mexico, C.P. 91900
        • Sociedad de Metabolismo y Corazon S.C.
      • Veracruz, Mexico, 91910
        • Arké SMO S.A de C.V
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 04530
        • Instituto Nacional de Pediatria
      • Mexico City, Distrito Federal, Mexico, 06720
        • Hospital Infantil de Mexico Federico Gomez
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • JM Research SC
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64718
        • Eukarya Pharmasite S.C.
    • Nuevo LEÓN
      • Monterrey, Nuevo LEÓN, Mexico, 64710
        • Tecnologico de Monterrey
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Kohler & Milstein Research S.A. De C.V.
    • Yucatán
      • Merida, Yucatán, Mexico, 97130
        • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
      • Mérida, Yucatán, Mexico, 97000
        • Unidad de Atencion Medica e Investigacion en Salud
      • Trujillo Alto, Puerto Rico, 00976
        • San Miguel Medical
    • Gauteng
      • Benoni, Gauteng, South Africa, 1500
        • Worthwhile Clinical Trials
      • Germiston, Gauteng, South Africa, 1401
        • CRISMO Research Centre
      • Pretoria, Gauteng, South Africa, 0184
        • Botho Ke Bontle Health Services
    • Limpopo
      • Dennilton, Limpopo, South Africa, 0470
        • Ndlovu Research Centre
      • Thabazimbi, Limpopo, South Africa, 0380
        • Limpopo Clinical Research Initiative
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust
      • Manchester, United Kingdom, M13 9WL
        • Royal Manchester Children's Hospital
    • England
      • London, England, United Kingdom, SW17 0QT
        • St. George's Hospital
    • London, CITY OF
      • London, London, CITY OF, United Kingdom, NW1 2PG
        • University College London Hospital
      • London, London, CITY OF, United Kingdom, SE5 9RL
        • King's College Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham - School of Medicine
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Los Angeles, California, United States, 90095
        • UCLA
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Miami, Florida, United States, 33130
        • Life Spring Research Foundation
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta - Egleston Hospital
      • Union City, Georgia, United States, 30291
        • SKY Clinical Research Network Group-Blake
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Novak Center for Children's Health
      • Louisville, Kentucky, United States, 40202
        • Norton Children´s Hospital
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Louisiana State University Health Sciences Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Chan Medical School
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne Pediatrics
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Childrens Hospitals and Clinics of Minnesota
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • SKY Clinical Research Network Group-Quinn
      • Ridgeland, Mississippi, United States, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Children's Hospital & Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Clinical and Translational Science Center
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Hospital, COVID-19 Research Clinic
    • New York
      • Buffalo, New York, United States, 14203
        • SUNY University at Buffalo
      • Commack, New York, United States, 11725
        • Advanced Specialty Care
      • East Setauket, New York, United States, 11733
        • Stony Brook Medicine Clinical Research Center
      • New Hyde Park, New York, United States, 11040
        • Cohen Children's Medical Center
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • Stony Brook, New York, United States, 11794-8111
        • Stony Brook University
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Upstate Golisano Children's Hospital
      • Syracuse, New York, United States, 13202
        • Upstate Health Care Center
      • Syracuse, New York, United States, 13210
        • Crouse Physicians Office Building
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Medical Center
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Children's Hospital
      • Chapel Hill, North Carolina, United States, 27514
        • Clinical and Translational Research Center
      • Chapel Hill, North Carolina, United States, 27514
        • investigational Drug Services Pharmacy, UNC Hospitals
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Global Clinical Research North
      • Durham, North Carolina, United States, 27705
        • Duke Vaccine and Trials Unit
      • Durham, North Carolina, United States, 27710
        • Duke University - Main Hospital and Clinics
      • Raleigh, North Carolina, United States, 27607
        • UNC Children's Raleigh
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Mayfield Heights, Ohio, United States, 44124
        • UH Landerbrook Health Center
      • Parma, Ohio, United States, 44129
        • UH Parma Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-4637
        • Oklahoma Childrens Hospital at OU Health
      • Oklahoma City, Oklahoma, United States, 73104-5008
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02904
        • The Miriam Hospital-Clinical Trials
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Coastal Pediatric Research
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera McKennan Hospital & University Health Center
      • Sioux Falls, South Dakota, United States, 57108
        • Avera Research Institute - Sioux Falls
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Le Bonheur Children's Hospital
      • Memphis, Tennessee, United States, 38105
        • Le Bonheur Children's Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • McAllen, Texas, United States, 78503
        • Biopharma Informatic, LLC
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Childrens Hospital of The Kings Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Male and female, age 0 to < 18 years, able to swallow for some participants
  • Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment
  • Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified COVID-19 signs/symptoms present at enrollment
  • Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Exclusion Criteria:

  • History of or need for hospitalization for the medical treatment of COVID-19
  • Total bilirubin >=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
  • Receiving dialysis or have known moderate to severe renal impairment
  • Suspected or confirmed concurrent active systemic infection other than COVID-19
  • History of hypersensitivity or other contraindication to any of the components of the study intervention
  • Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or strong inducers of cytochrome P450 (CYP)3A4
  • Has received or is expected to receive antibody treatment, antiviral treatment or convalescent COVID-19 plasma
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the study follow up
  • Females who are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 3 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir

≥2 to <6 years

PF-07321332
ritonavir
Experimental: Cohort 1 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total).

Weight ≥40 kg

  1. ≥12 to <18 years
  2. ≥6 to <12 years
PF-07321332
ritonavir
Experimental: Cohort 2 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years
PF-07321332
ritonavir
Experimental: Cohort 4 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir

≥1 month (≥28 days) to <2 years

PF-07321332
ritonavir
Experimental: Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir <1 month (<28 days) old
PF-07321332
ritonavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post dose

Pharmacokinetic (PK) sample(s) for Cohorts 1-2 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (10 to 13 total PK samples for Cohort 1 and 10 samples for Cohort 2).

Day 1: 1 hour-post dose by Tasso device and venous blood Day 4: pre-dose (Tasso) Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post AM dose (Tasso); for Cohort 1 pre-dose, and 1, 2 hours post AM dose venous samples in approximately 10 participants.

Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post dose
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post dose

Pharmacokinetic (PK) sample(s) for Cohorts 1-2 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (10 to 13 total PK samples for Cohort 1 and 10 samples for Cohort 2).

Day 1: 1 hour-post dose by Tasso device and venous blood Day 4: pre-dose (Tasso) Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post AM dose (Tasso); for Cohort 1 pre-dose, and 1, 2 hours post AM dose venous samples in approximately 10 participants.

Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post dose
Cohort 3: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 2: 2-8 hours post dose; Day 3: 2-8 hours post dose; Day 4: 2-8 hours post dose; Day 5: PK pre-dose and post-dose 1 to 3 hours

PK sample(s) Cohort 3 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (7 total samples)

Day 1: 1 hour-post dose Tasso and venous blood. Day 2: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 3: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 4: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 5: PK pre-dose and post-dose between 1 to 3 hours (Tasso)

Day 1: 1 hour-post dose; Day 2: 2-8 hours post dose; Day 3: 2-8 hours post dose; Day 4: 2-8 hours post dose; Day 5: PK pre-dose and post-dose 1 to 3 hours
Cohort 3: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 2: 2-8 hours post dose; Day 3: 2-8 hours post dose; Day 4: 2-8 hours post dose; Day 5: PK pre-dose and post-dose 1 to 3 hours

PK sample(s) Cohort 3 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (7 total samples)

Day 1: 1 hour-post dose Tasso and venous blood. Day 2: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 3: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 4: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 5: PK pre-dose and post-dose between 1 to 3 hours (Tasso)

Day 1: 1 hour-post dose; Day 2: 2-8 hours post dose; Day 3: 2-8 hours post dose; Day 4: 2-8 hours post dose; Day 5: PK pre-dose and post-dose 1 to 3 hours
Cohort 4-5: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours

PK sample(s) Cohorts 4-5 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (4 total samples)

Day 1: 1 hour-post dose Tasso and 1 venous blood. Day 5: PK pre-dose and post-dose AM between 3 to 5 hours (Tasso)

Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
Cohort 4-5: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours

PK sample(s) Cohorts 4-5 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (4 total samples)

Day 1: 1 hour-post dose Tasso and 1 venous blood. Day 5: PK pre-dose and post-dose AM between 3 to 5 hours (Tasso)

Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.
Time Frame: From Baseline up through Day 34
From Baseline up through Day 34
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
Time Frame: From Baseline up through Day 34
From Baseline up through Day 34
Incidence of Adverse Events (AEs) leading to discontinuations.
Time Frame: From Baseline up through Day 34
From Baseline up through Day 34
Number of participants with change from Baseline in Vital Signs
Time Frame: From Baseline up through Day 34
From Baseline up through Day 34

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with COVID-19 related hospitalization or death from any cause
Time Frame: From Baseline through Day 28
To evaluate the efficacy of nirmatrelvir/ritonavir for the treatment of COVID-19 in nonhospitalized symptomatic pediatric participants with COVID-19 who are at increased risk of progression to severe disease.
From Baseline through Day 28
Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
Time Frame: Baseline, Day 4, 5, 6, 10, 14 and 28
To evaluate the change in viral loads in pediatric participants from birth to <18 years of age with COVID-19 who are at risk of progression to severe disease.
Baseline, Day 4, 5, 6, 10, 14 and 28
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
Time Frame: At baseline only for tablets and after each dose for powder formulation
Frequency of responses to visual questionnaire on taste.
At baseline only for tablets and after each dose for powder formulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Estimated)

July 3, 2027

Study Completion (Estimated)

July 3, 2027

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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