COVID-19 Progression Study
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
- Sex: Any
- Age: Child (Birth - 17)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase II/III
- Conditions Being Studied: COVID-19
Study Purpose
The purpose of this study is to test the safety and efficacy of Nirmatrelvir/Ritonavir, for non-hospitalized children diagnosed with COVID-19 who are at risk of progression to severe COVID disease and have at least one underlying medical condition (i.e. obesity, neurodevelopmental disorders, immunosuppressive disease, chronic lung disease, cardiovascular disease, or kidney disease, hypertension, diabetes, sickle cell disease, etc.).
Who Can Participate
Participants between 6-17 years of age with at least one symptom of COVID-19 and have at least one underlying medical condition (i.e., overweight, current smoker, immunosuppressive disease, chronic lung, heart, or kidney disease, hypertension (high blood pressure), Type 1 or Type 2 Diabetes , Sickle Cell Disease, etc.) may be eligible for this study.
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
- UH IRB: SITE00001690
- StudyID: 2022-0870
- ClinicalTrials.gov: NCT05261139
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