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Protease Inhibitor

Nirmatrelvir/Ritonavir for COVID-19 in Children

Phase 2 & 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female, age 0 to < 18 years, able to swallow
Male and female, age 0 to < 18 years, able to swallow for some participants
Must not have
History of or need for hospitalization for the medical treatment of COVID-19
Receiving dialysis or have known moderate to severe renal impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Summary

This trial is testing a new drug to see if it is safe and effective in treating kids with COVID-19 who are not hospitalized.

Who is the study for?
This trial is for children and teenagers under 18 who can swallow pills, have tested positive for COVID-19 within the last 72 hours, are at risk of severe illness but not hospitalized. They must show symptoms within 5 days before joining. Those with certain treatments or conditions like severe kidney issues, other infections, or using specific drugs that affect the body's drug processing system cannot join.Check my eligibility
What is being tested?
The study tests PF-07321332 (Nirmatrelvir)/Ritonavir in young patients to see how safe it is and how well it works against COVID-19. It looks at how their bodies handle the medication and its effectiveness in preventing serious disease.See study design
What are the potential side effects?
While specific side effects for this age group aren't listed here, Nirmatrelvir/Ritonavir may cause gastrointestinal issues like diarrhea, taste disturbances, high blood pressure, muscle aches, and allergic reactions in adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are able to swallow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have been hospitalized for COVID-19 treatment or currently need hospitalization for COVID-19.
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You are currently on dialysis or have serious problems with your kidneys.
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You have a serious infection other than COVID-19.
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You are currently taking or expected to take medications that interact with CYP3A4, a protein in the body that breaks down certain medications.
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You have received or are going to receive specific treatments for COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Cohort 3: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
+7 more
Secondary outcome measures
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
Proportion of participants with COVID-19 related hospitalization or death from any cause
Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time

Side effects data

From 2012 Phase 4 trial • 68 Patients • NCT00757783
32%
Diarrhoea
26%
Nausea
16%
Cough
13%
Low Density Lipoprotein Increased
13%
Fatigue
13%
Pyrexia
10%
Abdominal Distension
10%
Immune Reconstitution Syndrome
6%
Weight Decreased
6%
Flatulence
6%
Tinea Pedis
6%
Upper Respiratory Tract Infection
6%
Decreased Appetite
6%
Penile Discharge
6%
Sinus Congestion
6%
Acne
6%
Pain
6%
Influenza
6%
Neutropenia
6%
Headache
6%
Rash
3%
Abdominal Pain
3%
Blood Cholesterol Increased
3%
Dyspepsia
3%
Urinary Tract Infection
3%
Dizziness
3%
Depression
3%
Insomnia
3%
Oral Herpes
3%
Pain in Extremity
3%
Pancreatitis
3%
Muscle Strain
3%
Blood Glucose Increased
3%
Diabetes Mellitus
3%
Chronic Obstructive Pulmonary Disease
3%
Respiratory Distress
100%
80%
60%
40%
20%
0%
Study treatment Arm
Darunavir
Atazanavir

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5 nirmatrelvir/ritonavirExperimental Treatment2 Interventions
nirmatrelvir/ritonavir <1 month (<28 days) old
Group II: Cohort 4 nirmatrelvir/ritonavirExperimental Treatment2 Interventions
nirmatrelvir/ritonavir ≥1 month (≥28 days) to <2 years
Group III: Cohort 3 nirmatrelvir/ritonavirExperimental Treatment2 Interventions
nirmatrelvir/ritonavir ≥2 to <6 years
Group IV: Cohort 2 nirmatrelvir/ritonavirExperimental Treatment2 Interventions
nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years
Group V: Cohort 1 nirmatrelvir/ritonavirExperimental Treatment2 Interventions
nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg ≥12 to <18 years ≥6 to <12 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ritonavir
2011
Completed Phase 4
~2000
nirmatrelvir
2022
Completed Phase 2
~450

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,610 Total Patients Enrolled
67 Trials studying COVID-19
1,436,879 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,219 Total Patients Enrolled
50 Trials studying COVID-19
1,425,680 Patients Enrolled for COVID-19

Media Library

Nirmatrelvir (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05261139 — Phase 2 & 3
COVID-19 Research Study Groups: Cohort 2 nirmatrelvir/ritonavir, Cohort 5 nirmatrelvir/ritonavir, Cohort 3 nirmatrelvir/ritonavir, Cohort 4 nirmatrelvir/ritonavir, Cohort 1 nirmatrelvir/ritonavir
COVID-19 Clinical Trial 2023: Nirmatrelvir Highlights & Side Effects. Trial Name: NCT05261139 — Phase 2 & 3
Nirmatrelvir (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05261139 — Phase 2 & 3
~74 spots leftby Jul 2026
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