RecruitingCOVID-19 Infection

A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised

Eligible age

18+ yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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 at baseline with mild-to-moderate COVID-19.

Sponsor: Pfizer

You may qualify if…

✓ 1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19
✓ 2. 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.
✓ 3. Severely immunocompromised due to:
✓ 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);
✓ Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;
✓ Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.

You may not qualify if…

✕ 1. Severe or critical COVID-19, or current need for supplemental oxygen.
✕ 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min)
✕ 3. Active liver disease
✕ 4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
✕ 5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
✕ 6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
✕ 7. 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.
✕ 8. Has received any other antiviral for the treatment of the current COVID-19 infection