A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
ConditionCOVID-19 Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
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.
Eligibility criteria
Qualifiers
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.
Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;
Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);
Disqualifiers
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
Trial design
Treatments tested in this trial
- ibuzatrelvir
- remdesivir
- placebo for ibuzatrelvir
- placebo for remdesivir
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov