A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With… (NCT06679140) | Clinical Trial Compass
RecruitingPhase 3
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
United States, Argentina, Belgium2,330 participantsStarted 2024-12-08
Plain-language summary
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial testing ibuzatrelvir for COVID-19 in people who aren't hospitalized but are at higher risk for severe disease — am I considered high-risk enough to be a potential candidate worth discussing with you?
2The trial is measuring emergency room visits, hospitalizations, and deaths as its main outcomes, but it's still enrolling — what do we currently know about ibuzatrelvir's safety profile compared to existing approved COVID-19 treatments like Paxlovid?
3Since this is a Phase 3 study, there's likely more safety data than earlier-phase trials, but results aren't final yet — how does that uncertainty affect whether this might make sense for me versus just using a standard approved treatment right now?
4This trial is for people who aren't hospitalized, so timing probably matters a lot — how quickly would I need to act after a COVID-19 diagnosis to even explore whether enrolling makes sense, and is that realistic given how I'd find out about my infection?
5Are there specific health conditions, medications I'm already taking, or other factors about my situation that would make this trial worth exploring with you — or that would make it a poor fit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality
. Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
Exclusion criteria
. Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \<94% on room air, respiratory rate \>30 breaths/minute, or lung infiltrates \>50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
. Receiving dialysis or have known severe renal impairment \[ie, eGFR consistently \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents\], using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.
. Active liver disease with AST or ALT \>3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's syndrome, direct bilirubin \>ULN is exclusionary) 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.
. History of hypersensitivity or other contraindication to any of the components of the study interventions.