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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
PF-07321332
ritonavir
Phoenix Children's Hospital
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGChildren's Hospital Los Angeles
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGKaiser Permanente
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGUCLA David Geffen School of Medicine
Los Angeles, California, United States
NOT_YET_RECRUITINGCohort 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
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
Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
Time frame: Baseline, Day 5, 6, 10, 14 and 28
Proportion of participants with COVID-19 related hospitalization or death from any cause
Time frame: From Baseline through Day 28
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
Frequency of responses to visual questionnaire on taste.
Time frame: At baseline only for tablets and after each dose for powder formulation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UCLA
Los Angeles, California, United States
NOT_YET_RECRUITINGChildren's National Medical Center
Washington D.C., District of Columbia, United States
ACTIVE_NOT_RECRUITINGLife Spring Research Foundation
Miami, Florida, United States
RECRUITINGChildren's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, Georgia, United States
RECRUITINGRophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
TERMINATEDAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
ACTIVE_NOT_RECRUITING...and 63 more locations