NCT07013474 A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
| NCT ID | NCT07013474 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | COVID-19 Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2027-09-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-07-14 with a primary completion date of 2027-09-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 at baseline with mild-to-moderate COVID-19.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). 10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational. 11. Prior participation in this trial or any clinical trial of ibuzatrelvir. 12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study. 13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07013474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COVID-19 Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07013474 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07013474 currently recruiting?
Yes, NCT07013474 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07013474 trial being conducted?
This trial is being conducted at Canoga Park, United States, Granada Hills, United States, La Jolla, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT07013474 clinical trial?
NCT07013474 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 300 participants.
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