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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
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 : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: nirmatrelvir Drug: ritonavir Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : July 3, 2027
Estimated Study Completion Date : July 3, 2027


Arm Intervention/treatment
Experimental: 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
Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir

Experimental: 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
Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir

Experimental: Cohort 3 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir

≥2 to <6 years

Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir

Experimental: Cohort 4 nirmatrelvir/ritonavir

nirmatrelvir/ritonavir

≥1 month (≥28 days) to <2 years

Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir

Experimental: Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir <1 month (<28 days) old
Drug: nirmatrelvir
PF-07321332

Drug: ritonavir
ritonavir




Primary Outcome Measures :
  1. 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, 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 to 13 total PK samples for Cohort 1 and 10 samples for Cohort 2).

    Day 1: 1 hour-post dose by Tasso device and venous blood Day 4: pre-dose (Tasso) Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post AM dose (Tasso); for Cohort 1 pre-dose, and 1, 2 hours post AM dose venous samples in approximately 10 participants.


  2. 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, 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 to 13 total PK samples for Cohort 1 and 10 samples for Cohort 2).

    Day 1: 1 hour-post dose by Tasso device and venous blood Day 4: pre-dose (Tasso) Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post AM dose (Tasso); for Cohort 1 pre-dose, and 1, 2 hours post AM dose venous samples in approximately 10 participants.


  3. Cohort 3: Maximum Observed Plasma Concentration (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 pre-dose and post-dose 1 to 3 hours ]

    PK sample(s) Cohort 3 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 venous blood. Day 2: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 3: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 4: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 5: PK pre-dose and post-dose between 1 to 3 hours (Tasso)


  4. Cohort 3: 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 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 ]

    PK sample(s) Cohort 3 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 venous blood. Day 2: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 3: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 4: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 5: PK pre-dose and post-dose between 1 to 3 hours (Tasso)


  5. Cohort 4-5: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir [ Time Frame: Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours ]

    PK sample(s) Cohorts 4-5 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (4 total samples)

    Day 1: 1 hour-post dose Tasso and 1 venous blood. Day 5: PK pre-dose and post-dose AM between 3 to 5 hours (Tasso)


  6. Cohort 4-5: 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 5: PK pre-dose and post-dose AM between 1 to 3 hours ]

    PK sample(s) Cohorts 4-5 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (4 total samples)

    Day 1: 1 hour-post dose Tasso and 1 venous blood. Day 5: PK pre-dose and post-dose AM between 3 to 5 hours (Tasso)


  7. Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations. [ Time Frame: From Baseline up through Day 34 ]
  8. Incidence of Serious Adverse Events (SAEs) leading to discontinuations. [ Time Frame: From Baseline up through Day 34 ]
  9. Incidence of Adverse Events (AEs) leading to discontinuations. [ Time Frame: From Baseline up through Day 34 ]
  10. Number of participants with change from Baseline in Vital Signs [ Time Frame: From Baseline up through Day 34 ]

Secondary Outcome Measures :
  1. 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, 14 and 28 ]
    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.

  2. 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.

  3. Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder) [ Time Frame: At baseline only for tablets and after each dose for powder formulation ]
    Frequency of responses to visual questionnaire on taste.



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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 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)
  • 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

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05261139    
Other Study ID Numbers: C4671026
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024
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

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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
Keywords provided by Pfizer:
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
Pediatrics
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
Nirmatrelvir
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