NCT07013474 · Pfizer
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
What this study is about
This is a Phase 3, randomly assigned, actively controlled, double-blinded, double-dummy, superiority study to evaluate the effectiveness 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 but do not require supplemental oxygen for COVID-19.
View original scientific description
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 but do not require supplemental oxygen for COVID-19.
Interventions
DRUG
ibuzatrelvir
tablet
DRUG
remdesivir
injection, for intravenous use
DRUG
placebo for ibuzatrelvir
tablet
DRUG
placebo for remdesivir
injection, for intravenous use
Primary outcome measures
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
Time frame: 38 days
The difference in the proportion of participants with the composite endpoint of a) COVID-19-related ED visits with administration of supplemental oxygen, COVID-19 antiviral, or IV treatment; COVID-19-related hospitalization; or all-cause mortality, and b) Evidence of recurrent or persistent SARS-CoV-2 infection
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years of age or older at screening. 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 lymphoma, 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 B-cell depleting therapies (eg, rituximab).
Exclusion criteria
- Current need for supplemental oxygen for treatment of COVID-19. 2. Receiving dialysis or have known severe renal
Where
- Canoga Park, California
- Granada Hills, California
- La Jolla, California
- Sacramento, California
- San Diego, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Hialeah, Florida
- Margate, Florida
- Miami, Florida
- Savannah, Georgia
- Boise, Idaho
And 18 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations