COVID-19
Conditions
Keywords
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), Pediatrics
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.
Interventions
DRUGnirmatrelvir
PF-07321332
DRUGritonavir
ritonavir
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with change from Baseline in Vital Signs | From Baseline up through Day 34 |
| Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations. | From Baseline up through Day 34 |
| Incidence of Serious Adverse Events (SAEs) leading to discontinuations. | From Baseline up through Day 34 |
| Incidence of Adverse Events (AEs) leading to discontinuations. | From Baseline up through Day 34 |
| Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir | 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 | Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with COVID-19 related hospitalization or death from any cause | From Baseline through Day 28 | — |
| Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder) | At baseline only for tablets and after each dose for powder formulation | Frequency of responses to visual questionnaire on taste. |
| Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time | Baseline, Day 5, 6, 10, 14 and 28 | — |
Countries
Bulgaria, Japan, Mexico, Puerto Rico, South Africa, United Kingdom, United States
Contacts
Primary ContactPfizer CT.gov Call Center
Outcome results
None listed