NCT05261139 · Pfizer
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
What this study is about
The purpose of this clinical trial is to learn about the safety, how the drug moves through the body (how the drug moves through the body helps us understand how the drug is changed and eliminated from your body after you take it), and effectiveness (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
View original scientific description
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).
Interventions
DRUG
nirmatrelvir
PF-07321332
DRUG
ritonavir
ritonavir
Primary outcome measures
Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Time frame: 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
Time frame: 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.
Time frame: From Baseline up through Day 34
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
Time frame: From Baseline up through Day 34
Incidence of Adverse Events (AEs) leading to discontinuations.
Time frame: From Baseline up through Day 34
Number of participants with change from Baseline in Vital Signs
Time frame: From Baseline up through Day 34
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 depe
Where
- Phoenix, Arizona
- Los Angeles, California
- Washington D.C., District of Columbia
- Miami, Florida
- Atlanta, Georgia
- Union City, Georgia
- Chicago, Illinois
- Shreveport, Louisiana
- Baltimore, Maryland
- Boston, Massachusetts
- Worcester, Massachusetts
- Minneapolis, Minnesota
And 23 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2025 · Source of record for eligibility and locations