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 (EPIC-Peds)

Pfizer Japan Inc.0 个研究点目标入组 160 人开始时间: 待定最近更新: 2025年5月12日

试验速览

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•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

•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

发起方