A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE
Overview
- Phase
- Phase 3
- Intervention
- nirmatrelvir
- Conditions
- COVID-19
- Sponsor
- Pfizer
- Enrollment
- 160
- Locations
- 73
- Primary Endpoint
- Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Arms & Interventions
Cohort 1 nirmatrelvir/ritonavir
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
Intervention: nirmatrelvir
Cohort 1 nirmatrelvir/ritonavir
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
Intervention: ritonavir
Cohort 2 nirmatrelvir/ritonavir
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
Intervention: nirmatrelvir
Cohort 2 nirmatrelvir/ritonavir
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
Intervention: ritonavir
Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥2 to \<6 years
Intervention: nirmatrelvir
Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥2 to \<6 years
Intervention: ritonavir
Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years
Intervention: nirmatrelvir
Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years
Intervention: ritonavir
Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir \<1 month (\<28 days) old
Intervention: nirmatrelvir
Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir \<1 month (\<28 days) old
Intervention: ritonavir
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time(Baseline, Day 5, 6, 10, 14 and 28)
- Proportion of participants with COVID-19 related hospitalization or death from any cause(From Baseline through Day 28)
- Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)(At baseline only for tablets and after each dose for powder formulation)