Actively Recruiting

Phase 3
Age: 0Years - 17Years
All Genders
NCT05261139

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

Led by Pfizer · Updated on 2025-07-17

160

Participants Needed

73

Research Sites

229 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Who Can Participate

Age: 0Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female participants aged 0 to under 18 years, able to swallow for some participants
  • Confirmed SARS-CoV-2 infection within 72 hours before enrollment
  • Initial onset of COVID-19 symptoms within 5 days before enrollment with at least one symptom present at enrollment
  • At least one characteristic or underlying medical condition increasing risk for severe COVID-19 illness
Not Eligible

You will not qualify if you...

  • History of or current need for hospitalization for COVID-19 treatment
  • Total bilirubin level 2 times or more above the upper limit of normal (except for Gilbert's syndrome)
  • Receiving dialysis or having known moderate to severe kidney impairment
  • Suspected or confirmed active systemic infection other than COVID-19
  • History of allergy or contraindication to any component of the study medicine
  • Current or expected use of medications highly dependent on CYP3A4 for clearance or strong CYP3A4 inducers
  • Have received or expect to receive antibody treatment, antiviral treatment, or convalescent COVID-19 plasma for COVID-19
  • Currently participating in another interventional clinical study with an investigational drug or device, including for COVID-19
  • Female participants who are pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 73 locations

1

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Active, Not Recruiting

2

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Active, Not Recruiting

3

Kaiser Permanente

Los Angeles, California, United States, 90027

Active, Not Recruiting

4

UCLA David Geffen School of Medicine

Los Angeles, California, United States, 90095

Not Yet Recruiting

5

UCLA

Los Angeles, California, United States, 90095

Not Yet Recruiting

6

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Active, Not Recruiting

7

Life Spring Research Foundation

Miami, Florida, United States, 33130

Actively Recruiting

8

Children's Healthcare of Atlanta - Arthur M. Blank Hospital

Atlanta, Georgia, United States, 30329

Actively Recruiting

9

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States, 30291

Terminated

10

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Active, Not Recruiting

11

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

12

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, United States, 71101

Actively Recruiting

13

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Not Yet Recruiting

14

Boston Medical Center

Boston, Massachusetts, United States, 02118

Active, Not Recruiting

15

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States, 01655

Terminated

16

Childrens Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States, 55404

Not Yet Recruiting

17

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States, 39157

Active, Not Recruiting

18

St. Louis Children's Hospital

St Louis, Missouri, United States, 63110

Not Yet Recruiting

19

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Not Yet Recruiting

20

Children's Hospital & Medical Center

Omaha, Nebraska, United States, 68114

Terminated

21

University of New Mexico Hospital, COVID-19 Research Clinic

Albuquerque, New Mexico, United States, 87102

Terminated

22

University of New Mexico Clinical and Translational Science Center

Albuquerque, New Mexico, United States, 87106

Terminated

23

Suny University at Buffalo

Buffalo, New York, United States, 14203

Not Yet Recruiting

24

Advanced Specialty Care

Commack, New York, United States, 11725

Not Yet Recruiting

25

Stony Brook Medicine Clinical Research Center

East Setauket, New York, United States, 11733

Not Yet Recruiting

26

Cohen Children's Medical Center

New Hyde Park, New York, United States, 11040

Not Yet Recruiting

27

Columbia University Irving Medical Center

New York, New York, United States, 10032

Not Yet Recruiting

28

Stony Brook University

Stony Brook, New York, United States, 11794

Not Yet Recruiting

29

Upstate Health Care Center

Syracuse, New York, United States, 13202

Not Yet Recruiting

30

Crouse Physicians Office Building

Syracuse, New York, United States, 13210

Not Yet Recruiting

31

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Not Yet Recruiting

32

Upstate Golisano Children's Hospital

Syracuse, New York, United States, 13210

Not Yet Recruiting

33

Clinical and Translational Research Center

Chapel Hill, North Carolina, United States, 27514

Terminated

34

investigational Drug Services Pharmacy, UNC Hospitals

Chapel Hill, North Carolina, United States, 27514

Terminated

35

UNC Children's Hospital

Chapel Hill, North Carolina, United States, 27514

Terminated

36

UNC Global Clinical Research North

Chapel Hill, North Carolina, United States, 27514

Terminated

37

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States, 27599

Terminated

38

UNC Children's Raleigh

Raleigh, North Carolina, United States, 27607

Terminated

39

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Active, Not Recruiting

40

UH Landerbrook Health Center

Mayfield Heights, Ohio, United States, 44124

Active, Not Recruiting

41

UH Parma Medical Center

Parma, Ohio, United States, 44129

Active, Not Recruiting

42

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Not Yet Recruiting

43

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Active, Not Recruiting

44

The Miriam Hospital-Clinical Trials

Providence, Rhode Island, United States, 02904

Active, Not Recruiting

45

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota, United States, 57105

Terminated

46

Avera Research Institute - Sioux Falls

Sioux Falls, South Dakota, United States, 57108

Terminated

47

Texas Children's Hospital

Houston, Texas, United States, 77030

Not Yet Recruiting

48

Biopharma Informatic, LLC

McAllen, Texas, United States, 78503

Terminated

49

Consano Clinical Research, LLC

Shavano Park, Texas, United States, 78231

Actively Recruiting

50

University of Utah

Salt Lake City, Utah, United States, 84108

Not Yet Recruiting

51

МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa

Gorna Oryahovitsa, Bulgaria, 5100

Not Yet Recruiting

52

"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -

Rousse, Bulgaria, 7002

Not Yet Recruiting

53

Medical Center-1-Sevlievo EOOD

Sevlievo, Bulgaria, 5400

Not Yet Recruiting

54

DCC "Alexandrovska"

Sofia, Bulgaria, 1431

Terminated

55

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD

Vratsa, Bulgaria, 3000

Not Yet Recruiting

56

Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo, Japan, 183-8561

Not Yet Recruiting

57

Osaka City General Hospital

Osaka, Japan, 534-0021

Not Yet Recruiting

58

Instituto Nacional de Pediatria

Mexico City, Mexico City, Mexico, 04530

Not Yet Recruiting

59

Hospital Infantil de Mexico Federico Gomez

Mexico City, Mexico City, Mexico, 06720

Active, Not Recruiting

60

JM Research SC

Cuernavaca, Morelos, Mexico, 62290

Active, Not Recruiting

61

Fundación Santos y De la Garza Evia

Monterrey, Nuevo León, Mexico, 64710

Active, Not Recruiting

62

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, Mexico, 64718

Terminated

63

Unidad de Atención Médica e Investigación en Salud

Mérida, Yucatán, Mexico, 97000

Active, Not Recruiting

64

Kohler & Milstein Research S.A. De C.V.

Mérida, Yucatán, Mexico, 97070

Active, Not Recruiting

65

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.

Mérida, Yucatán, Mexico, 97130

Active, Not Recruiting

66

Centenario Hospital Miguel Hidalgo

Aguascalientes, Mexico, 20259

Not Yet Recruiting

67

Arké SMO S.A de C.V

Veracruz, Mexico, 91900

Active, Not Recruiting

68

Sociedad de Metabolismo y Corazon S.C.

Veracruz, Mexico, C.P. 91900

Active, Not Recruiting

69

San Miguel Medical

Trujillo Alto, Puerto Rico, 00976

Not Yet Recruiting

70

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa, 1500

Active, Not Recruiting

71

CRISMO Research Centre

Germiston, Gauteng, South Africa, 1401

Active, Not Recruiting

72

Botho Ke Bontle Health Services

Pretoria, Gauteng, South Africa, 0184

Not Yet Recruiting

73

St. George's Hospital

London, England, United Kingdom, SW17 0QT

Active, Not Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

5

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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 | DecenTrialz