Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Japan / NCT05261139
Recruiting Phase 3

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

NCT05261139 · tracked via the Priya Life Science Japan tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2022-03-07
Last updated
2025-07-17

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

nirmatrelvir →ritonavir →

nirmatrelvir: PF-07321332

ritonavir: ritonavir

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir — Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
  • 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; Day 5: pre-dose, and 1, and 2 hours post dose
  • Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations. — From Baseline up through Day 34
  • Incidence of Serious Adverse Events (SAEs) leading to discontinuations. — From Baseline up through Day 34
  • Incidence of Adverse Events (AEs) leading to discontinuations. — From Baseline up through Day 34
  • Number of participants with change from Baseline in Vital Signs — From Baseline up through Day 34

Trial sites (73)

FacilityCityRegionStatus
Phoenix Children's Hospital Phoenix Arizona Active Not Recruiting
Children's Hospital Los Angeles Los Angeles California Active Not Recruiting
Kaiser Permanente Los Angeles California Active Not Recruiting
UCLA David Geffen School of Medicine Los Angeles California Not Yet Recruiting
UCLA Los Angeles California Not Yet Recruiting
Children's National Medical Center Washington D.C. District of Columbia Active Not Recruiting
Life Spring Research Foundation Miami Florida Recruiting
Children's Healthcare of Atlanta - Arthur M. Blank Hospital Atlanta Georgia Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia Terminated
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois Active Not Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Louisiana State University Health Sciences Shreveport Shreveport Louisiana Recruiting
Johns Hopkins Hospital Baltimore Maryland Not Yet Recruiting
Boston Medical Center Boston Massachusetts Active Not Recruiting
University of Massachusetts Chan Medical School Worcester Massachusetts Terminated
Childrens Hospitals and Clinics of Minnesota Minneapolis Minnesota Not Yet Recruiting
SKY Integrative Medical Center/SKYCRNG Ridgeland Mississippi Active Not Recruiting
St. Louis Children's Hospital St Louis Missouri Not Yet Recruiting
Washington University School of Medicine St Louis Missouri Not Yet Recruiting
Children's Hospital & Medical Center Omaha Nebraska Terminated
University of New Mexico Hospital, COVID-19 Research Clinic Albuquerque New Mexico Terminated
University of New Mexico Clinical and Translational Science Center Albuquerque New Mexico Terminated
Suny University at Buffalo Buffalo New York Not Yet Recruiting
Advanced Specialty Care Commack New York Not Yet Recruiting
Stony Brook Medicine Clinical Research Center East Setauket New York Not Yet Recruiting
Cohen Children's Medical Center New Hyde Park New York Not Yet Recruiting
Columbia University Irving Medical Center New York New York Not Yet Recruiting
Stony Brook University Stony Brook New York Not Yet Recruiting
Upstate Health Care Center Syracuse New York Not Yet Recruiting
Crouse Physicians Office Building Syracuse New York Not Yet Recruiting
SUNY Upstate Medical University Syracuse New York Not Yet Recruiting
Upstate Golisano Children's Hospital Syracuse New York Not Yet Recruiting
Clinical and Translational Research Center Chapel Hill North Carolina Terminated
investigational Drug Services Pharmacy, UNC Hospitals Chapel Hill North Carolina Terminated
UNC Children's Hospital Chapel Hill North Carolina Terminated
UNC Global Clinical Research North Chapel Hill North Carolina Terminated
University of North Carolina Medical Center Chapel Hill North Carolina Terminated
UNC Children's Raleigh Raleigh North Carolina Terminated
University Hospitals Cleveland Medical Center Cleveland Ohio Active Not Recruiting
UH Landerbrook Health Center Mayfield Heights Ohio Active Not Recruiting

+ 33 more sites — see the full list on the official registry below.

More Pfizer trials in Japan

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer Active, not recruiting
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies Recruiting
Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body. Recruiting
Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Recruiting
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib Active, not recruiting

Other trials for the same condition

Study of Secutrelvir in Participants With COVID-19 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05261139 on ClinicalTrials.gov ↗ ← All trials in Japan