COVID-19
Conditions
Interventions
nirmatrelvir and ritonavir
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Male and female, age 0 to < 18 years, able to swallow tablets of investigational drug 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *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 1and 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 1and 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] | — |
Secondary
| Measure | Time frame |
|---|---|
| *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) [Time Frame: At baseline only for tablets and after each dose for powder formulation] | — |
Countries
Bulgaria, Japan, Mexico, Puerto Rico, South Africa, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed