At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- nirmatrelvir (drug), ritonavir (drug)
- How long the study runs
- Study runs about 52 months (dates as stated)
- About the drug or intervention
- nirmatrelvir — drug: PF-07321332 · ritonavir — drug: ritonavir
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Pfizer, is testing a medicine called nirmatrelvir/ritonavir (also known as PF-07321332) in people under 18 who have COVID-19, are not in hospital, and are at risk of becoming very ill. The study aims to learn about this medicine in children and teenagers.
Who can take part
- Aged 0 to under 18, male or female; some participants need to be able to swallow
- Confirmed COVID-19 (SARS-CoV-2) infection within 72 hours before joining
- First COVID-19 signs or symptoms started within 5 days before joining, with at least one symptom still present
- Has at least one characteristic or health condition that raises the risk of severe COVID-19 illness
Who may not be able to
- Has been, or needs to be, in hospital for COVID-19 treatment
- High levels of a substance called bilirubin in the blood (2 or more times the normal limit), unless they have Gilbert's syndrome
- On dialysis or with known moderate to severe kidney problems
- Has another suspected or confirmed active infection besides COVID-19
- Has had a bad allergic reaction or cannot take any part of the study medicine
- Taking (or expecting to take) certain medicines that interact strongly with how the body processes this study medicine
- Has had or is expected to have antibody treatment, antiviral treatment, or convalescent COVID-19 plasma
- Taking part in another clinical study testing a new drug or device, including for COVID-19, during follow up
- Females who are pregnant or breastfeeding
What taking part involves
- • Taking the study medicine nirmatrelvir/ritonavir — details of dose and how it is given: Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about study visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 0 Years to 17 Years
- Who
- All
- Number of participants
- 160
- Started
- 2022-03-07
- Last checked
- 2025-07
Plain English Summary
What is this study?
- • Testing a new treatment for covid-19
- • Phase3 - 160 participants
- • 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)
Who can take part?
- • Ages 0 Years to 17 Years
- • Diagnosed with covid-19
Where?
- • London - St. George's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 0 Years - 17 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe...
Who cannot take part
- ✗History of or need for hospitalization for the medical treatment of COVID-19
- ✗Total liver blood test \>=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
- ✗Receiving dialysis or have known moderate to severe kidney impairment
- ✗Suspected or confirmed concurrent active systemic infection other than COVID-19
- ✗History of hypersensitivity or other safety concern to any of the components of the study intervention
See the full criteria
Where Is This Study? (1 UK site)
St. George's Hospital
London SW17 0QT, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT