Summary

Eligibility
for people ages 0-17 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

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

Keywords

COVID-19 Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) Pediatrics Ritonavir nirmatrelvir

Eligibility

You can join if…

Open to people ages 0-17

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Kaiser Permanente Medical Center Infectious Disease accepting new patients
    Los Angeles California 90027 United States
  • Kaiser Permanente accepting new patients
    Los Angeles California 90027 United States
  • Children's Hospital of Orange County accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT05261139
Phase
Phase 2/3 COVID-19 Research Study
Study Type
Interventional
Participants
Expecting 140 study participants
Last Updated