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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05261139
• Other study ID #: C4671026
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: March 7, 2022
• Est. completion date: July 3, 2027

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 160
• Est. completion date: July 3, 2027
• Est. primary completion date: July 3, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• nirmatrelvir
PF-07321332
• ritonavir
ritonavir

Locations

Country	Name	City	State
Bulgaria	?HAT "Sveti Ivan Rilski" Gorna Oryahovitsa	Gorna Oryahovitsa
Bulgaria	Diagnostic-Consultative Center I Lom EOOD	Lom
Bulgaria	DCC Sveti Georgi EOOD	Plovdiv
Bulgaria	"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -	Ruse
Bulgaria	Medical Center-1-Sevlievo EOOD	Sevlievo
Bulgaria	DCC "Alexandrovska"	Sofia
Bulgaria	Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD	Vratsa
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Debreceni Egyetem Klinikai Központ	Debrecen
Hungary	Markhot Ferenc Oktatokorhaz es Rendelointezet	Eger	Heves
Japan	Tokyo Metropolitan Children's Medical Center	Fuchu	Tokyo
Japan	Osaka City General Hospital	Osaka
Mexico	Centenario Hospital Miguel Hidalgo	Aguascalientes
Mexico	JM Research SC	Cuernavaca	Morelos
Mexico	Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan	Merida	Yucatán
Mexico	Kohler & Milstein Research S.A. De C.V.	Merida	Yucatan
Mexico	Unidad de Atención Médica e Investigación en Salud	Mérida	Yucatán
Mexico	Hospital Infantil de Mexico Federico Gomez	Mexico City	Distrito Federal
Mexico	Instituto Nacional de Pediatria	Mexico City	Distrito Federal
Mexico	Eukarya PharmaSite S.C.	Monterrey	Nuevo LEON
Mexico	Tecnologico de Monterrey	Monterrey	Nuevo LEÓN
Mexico	Arké SMO S.A de C.V	Veracruz
Mexico	Sociedad de Metabolismo y Corazon	Veracruz
Mexico	Sociedad de Metabolismo y Corazon S.C.	Veracruz
Puerto Rico	San Miguel Medical	Trujillo Alto
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Ndlovu Research Centre	Dennilton	Limpopo
South Africa	CRISMO Research Centre	Germiston	Gauteng
South Africa	Botho Ke Bontle Health Services	Pretoria	Gauteng
South Africa	Limpopo Clinical Research Initiative	Thabazimbi	Limpopo
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	King's College Hospital	London	London, CITY OF
United Kingdom	St. George's Hospital	London	England
United Kingdom	University College London Hospital	London	London, CITY OF
United Kingdom	Royal Manchester Children's Hospital	Manchester
United States	University of New Mexico Clinical and Translational Science Center	Albuquerque	New Mexico
United States	University of New Mexico Hospital, COVID-19 Research Clinic	Albuquerque	New Mexico
United States	Children's Healthcare of Atlanta - Egleston Hospital	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham - School of Medicine	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Suny University at Buffalo	Buffalo	New York
United States	Clinical and Translational Research Center	Chapel Hill	North Carolina
United States	investigational Drug Services Pharmacy, UNC Hospitals	Chapel Hill	North Carolina
United States	UNC Children's Hospital	Chapel Hill	North Carolina
United States	UNC Global Clinical Research North	Chapel Hill	North Carolina
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Advanced Specialty Care	Commack	New York
United States	Wayne Pediatrics	Detroit	Michigan
United States	Duke University - Main Hospital and Clinics	Durham	North Carolina
United States	Duke Vaccine And Trials Unit	Durham	North Carolina
United States	Stony Brook Medicine Clinical Research Center	East Setauket	New York
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Texas Children's Hospital	Houston	Texas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Kaiser Permanente	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	Norton Children´s Hospital	Louisville	Kentucky
United States	Novak Center for Children's Health	Louisville	Kentucky
United States	UH Landerbrook Health Center	Mayfield Heights	Ohio
United States	Biopharma Informatic, LLC	McAllen	Texas
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Life Spring Research Foundation	Miami	Florida
United States	Childrens Hospitals and Clinics of Minnesota	Minneapolis	Minnesota
United States	Rutgers University	New Brunswick	New Jersey
United States	Cohen Children's Medical Center	New Hyde Park	New York
United States	Columbia University Irving Medical Center	New York	New York
United States	Childrens Hospital of The Kings Daughters	Norfolk	Virginia
United States	Oklahoma Childrens Hospital at OU Health	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Children's Hospital & Medical Center	Omaha	Nebraska
United States	Children's Hospital of Orange County	Orange	California
United States	UH Parma Medical Center	Parma	Ohio
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital-Clinical Trials	Providence	Rhode Island
United States	UNC Children's Raleigh	Raleigh	North Carolina
United States	SKY Clinical Research Network Group-Quinn	Ridgeland	Mississippi
United States	SKY Integrative Medical Center/SKYCRNG	Ridgeland	Mississippi
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Louisiana State University Health Sciences Shreveport	Shreveport	Louisiana
United States	Avera McKennan Hospital & University Health Center	Sioux Falls	South Dakota
United States	Avera Research Institute - Sioux Falls	Sioux Falls	South Dakota
United States	Stony Brook University	Stony Brook	New York
United States	Coastal Pediatric Research	Summerville	South Carolina
United States	Crouse Physicians Office Building	Syracuse	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Upstate Golisano Children's Hospital	Syracuse	New York
United States	Upstate Health Care Center	Syracuse	New York
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	SKY Clinical Research Network Group-Blake	Union City	Georgia
United States	Children's National Medical Center	Washington	District of Columbia
United States	Clinical Site Partners, Inc.	Winter Park	Florida
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Hungary,  Japan,  Mexico,  Puerto Rico,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	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
Primary	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)	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
Primary	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)	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
Primary	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)	Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
Primary	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)	Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.		From Baseline up through Day 34
Primary	Incidence of Serious Adverse Events (SAEs) leading to discontinuations.		From Baseline up through Day 34
Primary	Incidence of Adverse Events (AEs) leading to discontinuations.		From Baseline up through Day 34
Primary	Number of participants with change from Baseline in Vital Signs		From Baseline up through Day 34
Secondary	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.	Baseline, Day 4, 5, 6, 10, 14 and 28
Secondary	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.	From Baseline through Day 28
Secondary	Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)	Frequency of responses to visual questionnaire on taste.	At baseline only for tablets and after each dose for powder formulation

External Links

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