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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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nirmatrelvir
ritonavir
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), Pediatrics

Eligibility Criteria

0 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Male and female, age 0 to < 18 years, able to swallow
  • 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) and/or absolute neutrophil count < 1000/mm3
  • 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 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

Sites / Locations

  • University of Alabama at Birmingham - School of MedicineRecruiting
  • Phoenix Children's Hospital
  • Arkansas Children's HospitalRecruiting
  • Children's Hospital Los AngelesRecruiting
  • Kaiser PermanenteRecruiting
  • UCLA
  • Children's Hospital of Orange CountyRecruiting
  • Connecticut Children's Medical Center
  • Children's National Medical CenterRecruiting
  • Life Spring Research FoundationRecruiting
  • Clinical Site Partners, Inc.Recruiting
  • Children's Healthcare of Atlanta - Egleston HospitalRecruiting
  • Rophe Adult and Pediatric Medicine/SKYCRNG
  • SKY Clinical Research Network Group-Blake
  • Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
  • University of Chicago Medical CenterRecruiting
  • Norton Children´s HospitalRecruiting
  • Novak Center for Children's HealthRecruiting
  • Louisiana State University Health Sciences ShreveportRecruiting
  • Johns Hopkins HospitalRecruiting
  • Boston Medical CenterRecruiting
  • University of Massachusetts Chan Medical SchoolRecruiting
  • Wayne PediatricsRecruiting
  • Childrens Hospitals and Clinics of MinnesotaRecruiting
  • SKY Clinical Research Network Group-Quinn
  • SKY Integrative Medical Center/SKYCRNG
  • St. Louis Children's HospitalRecruiting
  • Washington UniversityRecruiting
  • Children's Hospital & Medical Center
  • Hackensack University Medical CenterRecruiting
  • Rutgers UniversityRecruiting
  • University of New Mexico Hospital, COVID-19 Research Clinic
  • University of New Mexico Clinical and Translational Science Center
  • Suny University at BuffaloRecruiting
  • Advanced Specialty CareRecruiting
  • Stony Brook Medicine Clinical Research CenterRecruiting
  • Cohen Children's Medical CenterRecruiting
  • Columbia University Irving Medical CenterRecruiting
  • Stony Brook UniversityRecruiting
  • Upstate Health Care CenterRecruiting
  • Crouse Physicians Office BuildingRecruiting
  • SUNY Upstate Medical UniversityRecruiting
  • Upstate Golisano Children's HospitalRecruiting
  • Clinical and Translational Research CenterRecruiting
  • investigational Drug Services Pharmacy, UNC HospitalsRecruiting
  • UNC Children's HospitalRecruiting
  • UNC Global Clinical Research NorthRecruiting
  • University of North Carolina Medical CenterRecruiting
  • Duke Vaccine And Trials UnitRecruiting
  • Duke University - Main Hospital and ClinicsRecruiting
  • UNC Children's RaleighRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • UH Landerbrook Health CenterRecruiting
  • UH Parma Medical CenterRecruiting
  • Oklahoma Childrens Hospital at OU Health
  • University of Oklahoma Health Sciences Center
  • Children's Hospital of Pittsburgh
  • Rhode Island Hospital
  • The Miriam Hospital-Clinical Trials
  • Coastal Pediatric ResearchRecruiting
  • Avera McKennan Hospital & University Health Center
  • Avera Research Institute - Sioux Falls
  • Le Bonheur Children's Hospital
  • Le Bonheur Children's Hospital
  • Texas Children's HospitalRecruiting
  • Biopharma Informatic, LLCRecruiting
  • Consano Clinical Research, LLCRecruiting
  • University of UtahRecruiting
  • Childrens Hospital of The Kings DaughtersRecruiting
  • МHAT "Sveti Ivan Rilski" Gorna OryahovitsaRecruiting
  • Diagnostic-Consultative Center I Lom EOODRecruiting
  • DCC Sveti Georgi EOODRecruiting
  • "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -Recruiting
  • Medical Center-1-Sevlievo EOODRecruiting
  • DCC "Alexandrovska"Recruiting
  • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOODRecruiting
  • Markhot Ferenc Oktatokorhaz es Rendelointezet
  • Debreceni Egyetem Klinikai Kozpont
  • Debreceni Egyetem Klinikai KözpontRecruiting
  • Instituto Nacional de Pediatria
  • Hospital Infantil de Mexico Federico Gomez
  • JM Research SC
  • Eukarya PharmaSite S.C.
  • Tecnologico de Monterrey
  • Kohler & Milstein Research S.A. De C.V.
  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
  • Unidad de Atención Médica e Investigación en Salud
  • Centenario Hospital Miguel Hidalgo
  • Sociedad de Metabolismo y Corazon
  • Arké SMO S.A de C.V
  • Sociedad de Metabolismo y Corazon S.C.
  • San Miguel MedicalRecruiting
  • Worthwhile Clinical TrialsRecruiting
  • CRISMO Research CentreRecruiting
  • Botho Ke Bontle Health ServicesRecruiting
  • Ndlovu Research Centre
  • Limpopo Clinical Research InitiativeRecruiting
  • St. George's Hospital
  • University College London Hospital
  • King's College Hospital
  • Imperial College Healthcare NHS Trust
  • Royal Manchester Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 nirmatrelvir/ritonavir

Cohort 2 nirmatrelvir/ritonavir

Cohort 3 nirmatrelvir/ritonavir

Cohort 4 nirmatrelvir/ritonavir

Cohort 5 nirmatrelvir/ritonavir

Arm Description

nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg ≥12 to <18 years ≥6 to <12 years

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

nirmatrelvir/ritonavir ≥2 to <6 years

nirmatrelvir/ritonavir ≥1 month (≥28 days) to <2 years

nirmatrelvir/ritonavir <1 month (<28 days) old

Outcomes

Primary Outcome Measures

Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
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.
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
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.
Cohort 3: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
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)
Cohort 3: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
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)
Cohort 4-5: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
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)
Cohort 4-5: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
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)
Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
Incidence of Adverse Events (AEs) leading to discontinuations.
Number of participants with change from Baseline in Vital Signs

Secondary Outcome Measures

Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
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.
Proportion of participants with COVID-19 related hospitalization or death from any cause
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.
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
Frequency of responses to visual questionnaire on taste.

Full Information

First Posted
February 25, 2022
Last Updated
October 13, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05261139
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
July 3, 2027 (Anticipated)
Study Completion Date
July 3, 2027 (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
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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.

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), Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 nirmatrelvir/ritonavir
Arm Type
Experimental
Arm Description
nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg ≥12 to <18 years ≥6 to <12 years
Arm Title
Cohort 2 nirmatrelvir/ritonavir
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 3 nirmatrelvir/ritonavir
Arm Type
Experimental
Arm Description
nirmatrelvir/ritonavir ≥2 to <6 years
Arm Title
Cohort 4 nirmatrelvir/ritonavir
Arm Type
Experimental
Arm Description
nirmatrelvir/ritonavir ≥1 month (≥28 days) to <2 years
Arm Title
Cohort 5 nirmatrelvir/ritonavir
Arm Type
Experimental
Arm Description
nirmatrelvir/ritonavir <1 month (<28 days) old
Intervention Type
Drug
Intervention Name(s)
nirmatrelvir
Intervention Description
PF-07321332
Intervention Type
Drug
Intervention Name(s)
ritonavir
Intervention Description
ritonavir
Primary Outcome Measure Information:
Title
Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Description
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.
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
Title
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Description
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.
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
Title
Cohort 3: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Description
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)
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
Title
Cohort 3: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Description
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)
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
Title
Cohort 4-5: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Description
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)
Time Frame
Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
Title
Cohort 4-5: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Description
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)
Time Frame
Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
Title
Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.
Time Frame
From Baseline up through Day 34
Title
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
Time Frame
From Baseline up through Day 34
Title
Incidence of Adverse Events (AEs) leading to discontinuations.
Time Frame
From Baseline up through Day 34
Title
Number of participants with change from Baseline in Vital Signs
Time Frame
From Baseline up through Day 34
Secondary Outcome Measure Information:
Title
Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
Description
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.
Time Frame
Baseline, Day 4, 5, 6, 10, 14 and 28
Title
Proportion of participants with COVID-19 related hospitalization or death from any cause
Description
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.
Time Frame
From Baseline through Day 28
Title
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
Description
Frequency of responses to visual questionnaire on taste.
Time Frame
At baseline only for tablets and after each dose for powder formulation

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4671026
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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