A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely I… (NCT07013474) | Clinical Trial Compass
RecruitingPhase 3
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
United States300 participantsStarted 2025-07-14
Plain-language summary
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention.
✓. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.
✓. Severely immunocompromised due to:
Exclusion criteria
✕. Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19.
✕. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min/1.73 m2)
✕. Active liver disease
✕. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
✕. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
✕. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
✕. Any medical or psychiatric condition including recent (within the past year) 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.
What they're measuring
1
The difference in the proportion of patients meeting the primary composite endpoint, between ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants with COVID-19 who are severely immunocompromised