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
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| ClinicalTrials.gov Identifier: NCT05261139 |
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Recruitment Status :
Suspended
(Recruitment was paused to allow time for further pharmacokinetic modelling and simulation work to be performed to determine further dose regimens and PK blood sampling. No safety concerns have been observed in participants enrolled to date.)
First Posted : March 2, 2022
Last Update Posted : March 21, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: nirmatrelvir Drug: ritonavir | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | March 7, 2022 |
| Estimated Primary Completion Date : | November 25, 2023 |
| Estimated Study Completion Date : | November 25, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as tablets by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg
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Drug: nirmatrelvir
PF-07321332 Drug: ritonavir ritonavir |
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Experimental: Cohort 2 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as tablets by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years
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Drug: nirmatrelvir
PF-07321332 Drug: ritonavir ritonavir |
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Experimental: Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥2 to <6 years |
Drug: nirmatrelvir
PF-07321332 Drug: ritonavir ritonavir |
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Experimental: Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥1 month to <2 years |
Drug: nirmatrelvir
PF-07321332 Drug: ritonavir ritonavir |
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Experimental: Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir <1 month old
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Drug: nirmatrelvir
PF-07321332 Drug: ritonavir ritonavir |
- Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir [ Time Frame: Day 1: 1 hour-post dose; Day 4: pre-dose or trough; Day 5: pre-dose or trough, and 1, 2, 4, 6, 8, and 10 hours post dose ]
Pharmacokinetic (PK) sample(s) for Cohorts 1-2 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (10 total PK samples)
Day 1: 1 hour-post dose by Tasso device and 1 mL venous blood Day 4: pre-dose or trough (Tasso only) Day 5: pre-dose or trough, and 1, 2, 4, 6, 8, and 10 hours post AM dose (Tasso only)
- Cohort 3-5: Cmax of nirmatrelvir and ritonavir [ Time Frame: 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 trough and post-dose 1 to 3 hours ]
PK sample(s) Cohorts 3-5 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (7 total samples)
Day 1: 1 hour-post dose Tasso and 1 mL venous blood. Day 2: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 3: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 4: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 5: PK trough and post-dose 1 to 3 hours (Tasso only)
- 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 or trough; Day 5: pre-dose or trough, and 1, 2, 4, 6, 8, and 10 hours post dose ]
Pharmacokinetic (PK) sample(s) for Cohorts 1-2 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (10 total PK samples)
Day 1: 1 hour-post dose by Tasso device and 1 mL venous blood Day 4: pre-dose or trough (Tasso only) Day 5: pre-dose or trough, and 1, 2, 4, 6, 8, and 10 hours post AM dose (Tasso only)
- Cohort 3-5: AUC0-tau of nirmatrelvir and ritonavir [ Time Frame: 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 trough and post-dose 1 to 3 hours ]
PK sample(s) Cohorts 3-5 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (7 total samples)
Day 1: 1 hour-post dose Tasso and 1 mL venous blood. Day 2: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 3: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 4: 2-8 hours post AM dose prior to PM dose (Tasso only) Day 5: PK trough and post-dose 1 to 3 hours (Tasso only)
- Incidence of TEAEs, SAEs, AEs leading to discontinuations, and vital sign measurements [ Time Frame: From Baseline up through Day 34 ]
- Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time [ Time Frame: Baseline, Day 4, 5, 6, 10, and 14 ]To evaluate the change in viral loads in pediatric participants from birth to <18 years of age with COVID-19 who are at risk of progression to severe disease.
- Proportion of participants with COVID-19 related hospitalization or death from any cause [ Time Frame: From Baseline through Day 28 ]To evaluate the efficacy of nirmatrelvir/ritonavir for the treatment of COVID-19 in nonhospitalized symptomatic pediatric participants with COVID-19 who are at increased risk of progression to severe disease.
- Patient assessment on palatability of nirmatrelvir (film-coated tablets and age-appropriate formulation) [ Time Frame: At baseline only ]Frequency of responses to visual questionnaire on taste.
- Patient assessment on palatability of ritonavir (age-appropriate formulation) [ Time Frame: At baseline only ]Frequency of responses to visual questionnaire on taste.
- Patient assessment on acceptability of nirmatrelvir (film-coated tablets and age-appropriate formulation) [ Time Frame: At baseline only ]Frequency of responses to visual questionnaire swallowability
- Patient assessment on acceptability of ritonavir (age-appropriate formulation) [ Time Frame: At baseline only ]Frequency of responses to visual questionnaire swallowability
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 0 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Male and female, age 0 to < 18 years, able to swallow
- 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) and/or absolute neutrophil count < 1000/mm3
- 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 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05261139
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| Study Director: | Pfizer CT.gov Call Center | Pfizer |
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT05261139 |
| Other Study ID Numbers: |
C4671026 |
| First Posted: | March 2, 2022 Key Record Dates |
| Last Update Posted: | March 21, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) Pediatrics |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
Ritonavir HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |