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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

+3 more

Secondary study objectives

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

34%

Blood Bilirubin Increased

21%

Depression

17%

Ocular Icterus

17%

Diarrhoea

14%

Hyperbilirubinaemia

10%

Insomnia

10%

Pain in Extremity

10%

Fatigue

10%

Jaundice

10%

Low Density Lipoprotein Increased

Pollakiuria

Neutrophil Count Decreased

Neutropenia

Abdominal Distension

Dyspepsia

Nausea

Abdominal Pain

Flatulence

Folliculitis

Furuncle

Oral Herpes

Upper Respiratory Tract Infection

Urinary Tract Infection

Dizziness

Headache

Seasonal Allergy

Blood Cholesterol Increased

Chest Pain

Bacteraemia

Pneumonia

Pneumonitis Chemical

Purpura

Pyrexia

Mitral Valve Incompetence

Fracture of Penis

Sinus Congestion

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Atazanavir

Darunavir

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 1. ≥12 to \<18 years 2. ≥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