A Phase 2/3 Safety, Pharmacokinetics, and Efficacy Study ofNirmatrelvir/Ritonavir in Pediatric, Nonhospitalized Symptomatic Participants With COVID-19 Who Are at Risk of Progression to Severe Disease

You may be able to join if

• Male or female participants: • Cohort 1: Weight ≥40 kg a. ≥12 to <18 years b. ≥6 to <12 years” Cohort 2: Weight ≥20 kg to <40 kg, ≥6 to <18 years • Cohort 3: ≥2 to <6 years • Cohort 4: ≥1 month (≥28 days) to <2 years • Cohort 5: <1 month (<28 days) From birth (postmenstrual age of 44 weeks or greater weighing >2.6 kg at the time of screening) to <18 years of age. Negative urine pregnancy test for female participants who are biologically capable of having children. Female participant of childbearing potential who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her partner.Note: If the childbearing potential changes after start of the study (eg, a premenarchal female participant experiences menarche) or the risk of pregnancy changes (eg, a female participant who was not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception. If reproductive status is questionable, additional evaluation should be considered.
• Until oral powder is available for use, ability to swallow tablets confirmed by participants’ parent(s)/legal guardian(s) for Cohorts 1 and 2 using the presentation of nirmatrelvir/ritonavir supplied in the study.
• Confirmed SARS-CoV-2 infection as determined by RT-PCR or another method of diagnosis approved by a health authority in any specimen collected within 72 hours prior to enrollment and initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of enrollment and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of enrollment. Note: RT-PCR is the preferred method; however, with evolving approaches to confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed. The test result must be available to confirm eligibility. Participants may be enrolled based on positive results of a rapid SARS-CoV-2 antigen test performed at screening.
• Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19 including:Risk factors for severe COVID-19 disease <18 years of age: • Overweight or Obese (BMI [kg/m2] ≥85th percentile for age and gender based on CDC growth charts o For children <2 years of age, sex specific weight-for-length; • Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes; • Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications: o Has received corticosteroids at a dose known to cause immune suppression, based on the clinical judgement of the investigator, for at least 14 days, within 30 days prior to study entry o Has received treatment with biologics (eg, infliximab, ustekinumab), immunomodulators (eg, methotrexate, 6MP, azathioprine) or cancer chemotherapy within 90 days prior to study entry o HIV infection with CD4 cell count <200 mm3 and a viral load lower than 400 copies/mL; • Chronic lung disease o If asthma, requires daily prescribed therapy; • Known diagnosis of hypertension; • Cardiovascular disease; • Type 1 or Type 2 diabetes mellitus; • Chronic kidney disease defined as eGFR between 45 to 89 mL/min/1.73m2 or eCrCl between 45 to 89 mL/min; • Sickle cell disease; • Neurodevelopmental disorders (eg, cerebral palsy, Down’s syndrome, ADHD, intellectual and developmental disabilities, learning disabilities, limitations with self-care of activities of daily living) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes and severe congenital anomalies, congenital malformations); • Active cancer, other than localized skin cancer, including those requiring treatment as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period; • Infants (<1 year of age); • Spinal cord injury • Any new criteria identified by the CDC as a risk factor for severe COVID-19 for pediatric participants.