Clincosm LogoSign in Get a demo

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

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05261139
Collaborator
(none)
140
Enrollment
96
Locations
5
Arms
16.3
Anticipated Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 7, 2022
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1 nirmatrelvir/ritonavir

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

Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir
Experimental: Cohort 2 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir will be given as tablets by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years

Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir
Experimental: Cohort 3 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir ≥2 to <6 years

Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir
Experimental: Cohort 4 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir ≥1 month to <2 years

Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir
Experimental: Cohort 5 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir <1 month old

Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir

Outcome Measures

Primary Outcome Measures

  1. Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir [Day 1: 1 hour-post dose; Day 4: pre-dose or trough; Day 5: pre-dose or trough, 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 total PK samples) Day 1: 1 hour-post dose by Tasso device and 1 mL venous blood Day 4: pre-dose or trough (Tasso only) Day 5: pre-dose or trough, and 1, 2, 4, 6, 8, and 10 hours post AM dose (Tasso only)

  2. Cohort 3-5: Cmax of nirmatrelvir and ritonavir [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 trough and post-dose 1 to 3 hours]

    PK sample(s) Cohorts 3-5 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 1 mL venous blood. Day 2: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 3: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 4: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 5: PK trough and post-dose 1 to 3 hours (Tasso only)

  3. Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir [Day 1: 1 hour-post dose; Day 4: pre-dose or trough; Day 5: pre-dose or trough, 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 total PK samples) Day 1: 1 hour-post dose by Tasso device and 1 mL venous blood Day 4: pre-dose or trough (Tasso only) Day 5: pre-dose or trough, and 1, 2, 4, 6, 8, and 10 hours post AM dose (Tasso only)

  4. Cohort 3-5: AUC0-tau of nirmatrelvir and ritonavir [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 trough and post-dose 1 to 3 hours]

    PK sample(s) Cohorts 3-5 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 1 mL venous blood. Day 2: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 3: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 4: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 5: PK trough and post-dose 1 to 3 hours (Tasso only)

  5. Incidence of TEAEs, SAEs, AEs leading to discontinuations, and vital sign measurements [From Baseline up through Day 34]

Secondary Outcome Measures

  1. Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time [Baseline, Day 4, 5, 6, 10, and 14]

    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.

  2. Proportion of participants with COVID-19 related hospitalization or death from any cause [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.

  3. Patient assessment on palatability of nirmatrelvir (film-coated tablets and age-appropriate formulation) [At baseline only]

    Frequency of responses to visual questionnaire on taste.

  4. Patient assessment on palatability of ritonavir (age-appropriate formulation) [At baseline only]

    Frequency of responses to visual questionnaire on taste.

  5. Patient assessment on acceptability of nirmatrelvir (film-coated tablets and age-appropriate formulation) [At baseline only]

    Frequency of responses to visual questionnaire swallowability

  6. Patient assessment on acceptability of ritonavir (age-appropriate formulation) [At baseline only]

    Frequency of responses to visual questionnaire swallowability

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Childrens of Alabama Birmingham Alabama United States 35233
2 Phoenix Children's Hospital Phoenix Arizona United States 85016
3 Arkansas Children's Hospital Little Rock Arkansas United States 72202
4 Children's Hospital Los Angeles Los Angeles California United States 90027
5 Kaiser Permanente Medical Center Infectious Disease Los Angeles California United States 90027
6 Kaiser Permanente Los Angeles California United States 90027
7 UCLA Los Angeles California United States 90095
8 Children's Hospital of Orange County Orange California United States 92868
9 Connecticut Children's Medical Center Hartford Connecticut United States 06106
10 Children's National Medical Center Washington District of Columbia United States 20010
11 Life Spring Research Foundation Miami Florida United States 33130
12 Clinical Site Partners, Inc. Winter Park Florida United States 32789
13 Children's Healthcare of Atlanta - Egleston Hospital Atlanta Georgia United States 30322
14 SKY Clinical Research Network Group-Blake Union City Georgia United States 30291
15 Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60611
16 University of Chicago Medical Center Chicago Illinois United States 60637
17 Louisiana State University Health Sciences Shreveport Shreveport Louisiana United States 71101
18 Boston Medical Center Boston Massachusetts United States 02118
19 University of Massachusetts Chan Medical School Worcester Massachusetts United States 01655
20 Wayne Pediatrics Detroit Michigan United States 48201
21 Quinn Healthcare/SKYCRNG Ridgeland Mississippi United States 39157
22 St. Louis Children's Hospital Saint Louis Missouri United States 63110
23 Washington University Saint Louis Missouri United States 63110
24 Children's Hospital & Medical Center Omaha Nebraska United States 68114
25 Hackensack University Medical Center Hackensack New Jersey United States 07601
26 Rutgers University New Brunswick New Jersey United States 08901
27 University of New Mexico Hospital, COVID-19 Research Clinic Albuquerque New Mexico United States 87102
28 University of New Mexico Clinical and Translational Science Center Albuquerque New Mexico United States 87106
29 Suny University at Buffalo Buffalo New York United States 14203
30 Advanced Specialty Care Commack New York United States 11725
31 Stony Brook Medicine Clinical Research Center East Setauket New York United States 11733
32 Cohen Children's Medical Center New Hyde Park New York United States 11040
33 Columbia University Irving Medical Center New York New York United States 10032
34 New York-Presbyterian Hospital - Columbia University Irving Medical Center - Milstein Hospital New York New York United States 10032
35 Stony Brook University Stony Brook New York United States 11794-8111
36 Upstate Health Care Center Syracuse New York United States 13202
37 Crouse Physicians Office Building Syracuse New York United States 13210
38 SUNY Upstate Medical University Syracuse New York United States 13210
39 Upstate Golisano Children's Hospital Syracuse New York United States 13210
40 Clinical and Translational Research Center Chapel Hill North Carolina United States 27514
41 investigational Drug Services Pharmacy, UNC Hospitals Chapel Hill North Carolina United States 27514
42 UNC Children's Hospital Chapel Hill North Carolina United States 27514
43 UNC Global Clinical Research North Chapel Hill North Carolina United States 27514
44 University of North Carolina Medical Center Chapel Hill North Carolina United States 27514
45 Duke Research at Pickett Road Durham North Carolina United States 27705
46 UNC Children's Raleigh Raleigh North Carolina United States 27607
47 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
48 Senders Pediatrics Cleveland Ohio United States 44121
49 UH Landerbrook Health Center Mayfield Heights Ohio United States 44124
50 UH Parma Medical Center Parma Ohio United States 44129
51 Oklahoma Childrens Hospital at OU Health Oklahoma City Oklahoma United States 73104-4637
52 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104-5008
53 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
54 Coastal Pediatric Research Summerville South Carolina United States 29486
55 Avera McKennan Hospital & University Health Center Sioux Falls South Dakota United States 57105
56 Avera Research Institute - Sioux Falls Sioux Falls South Dakota United States 57108
57 Le Bonheur Children's Hospital Memphis Tennessee United States 38103
58 Le Bonheur Children's Hospital Memphis Tennessee United States 38105
59 Gulf Bank Medical Center Houston Texas United States 77037
60 1960 Family Practice Houston Texas United States 77090
61 Zion Urgent Care Clinic Katy Texas United States 77494
62 Biopharma Informatic, LLC McAllen Texas United States 78503
63 Consano Clinical Research, LLC Shavano Park Texas United States 78231
64 Childrens Hospital of The Kings Daughters Norfolk Virginia United States 23507
65 МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa Gorna Oryahovitsa Bulgaria 5100
66 Diagnostic-Consultative Center I Lom EOOD Lom Bulgaria 3600
67 DCC Sveti Georgi EOOD Plovdiv Bulgaria 4000
68 "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov - Ruse Bulgaria 7002
69 Medical Center-1-Sevlievo EOOD Sevlievo Bulgaria 5400
70 DCC "Alexandrovska" Sofia Bulgaria 1431
71 Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD Vratsa Bulgaria 3000
72 Markhot Ferenc Oktatokorhaz es Rendelointezet Eger Heves Hungary 3300
73 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 04032
74 Debreceni Egyetem Klinikai Központ Debrecen Hungary 4031
75 Instituto Nacional de Pediatria Mexico City Distrito Federal Mexico 04530
76 Hospital Infantil de Mexico Federico Gomez Mexico City Distrito Federal Mexico 06720
77 JM Research Cuernavaca Morelos Mexico 62290
78 Tecnologico de Monterrey Monterrey Nuevo LEON Mexico 64710
79 Tecnologico de Monterrey Monterrey Nuevo LEÓN Mexico 64710
80 Eukarya Pharmasite S.C. Monterrey Nuevo LEÓN Mexico 64718
81 Centro de Especialidades Medicas del Sureste S.A. de C.V. Merida Yucatán Mexico 97000
82 Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan Merida Yucatán Mexico 97130
83 Unidad de Atención Médica e Investigación en Salud Mérida Yucatán Mexico 97000
84 Köhler & Milstein Research Mérida Yucatán Mexico 97070
85 Centenario Hospital Miguel Hidalgo Aguascalientes Mexico 20259
86 Sociedad de Metabolismo y Corazon Veracruz Mexico 91900
87 Arké SMO S.A de C.V Veracruz Mexico 91910
88 San Miguel Medical Trujillo Alto Puerto Rico 00976
89 Worthwhile Clinical Trials Benoni Gauteng South Africa 1500
90 CRISMO Research Centre Germiston Gauteng South Africa 1401
91 Botho Ke Bontle Health Services Pretoria Gauteng South Africa 0184
92 Ndlovu Research Centre Dennilton Limpopo South Africa 0470
93 Limpopo Clinical Research Initiative Thabazimbi Limpopo South Africa 0380
94 St. George's Hospital London England United Kingdom SW17 0QT
95 King's College Hospital London London, CITY OF United Kingdom SE5 9RL
96 Imperial College Healthcare NHS Trust London United Kingdom W2 1NY

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:
NCT05261139
Other Study ID Numbers:
  • C4671026
First Posted:
Mar 2, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Pfizer
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
Pediatrics
Additional relevant MeSH terms:
COVID-19
Ritonavir

Study Results

No Results Posted as of Aug 23, 2022