Last updated 8 days ago
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
2330 patients around the world
Available in Argentina, United States
Pfizer
1Research sites
2330Patients around the world
This study is for people with
Covid-19
Covid-19 pneumonia
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.Presence of risk factors for progression to severe COVID-19 at the time of screening based on age.12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise.50 to 64 years of age with at least two risk factors.65 to 74 years of age with at least one risk factor.For participants 75 years of age or older, there are no requirements related to risk factors.The list of risk factors includes: BMI ≥30 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.Confirmed SARS-CoV-2 infection as determined by RAT in nasal specimen collected within 1 day prior to randomization.Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
- Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness or due to other medical conditions requiring hospitalization in the opinion of the site investigator.Receiving dialysis or have known severe renal impairment within 6 months of the screening visit.Active liver disease with AST or ALT >3 ULN, Total bilirubin ≥2 × ULN within the past 3 months, or liver function impairment with Class C per Child Pugh classification.Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.Severely immunocompromised.Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.Any medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.Current use of any prohibited concomitant medication(s).Has received any other antiviral for the treatment of COVID-19 within 30 days or 5 half-lives prior to screening, or received convalescent COVID-19 plasma within 12 months.Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.Previous administration of an investigational product within 30 days or 5 half lives preceding the first dose of study intervention used in this study.Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Sites
Clínica Mayo de UMCB SRL
SponsorPfizer
Study typeInterventional
Conditions
Covid-19 pneumonia
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06679140
