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

RecruitingPhase 3

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED

Who can join

Ages 18 and older · All sexes

Full 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.

About the 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.

What is being tested

Sponsor: Pfizer · Participants: 300 · Started: Jul 14, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07013474

Locations in the U.S.

CaliforniaHope Clinical Research, Inc., Canoga Park
Amicis Research Center - Granada Hills, Granada Hills
Jacobs Medical Center at UC San Diego Health, La Jolla
UC Davis CTSC Clinical Research Center, Sacramento
University of California Davis Health, Sacramento
UC San Diego Medical Center - Hillcrest, San Diego
University of California San Diego Health, San Diego
ColoradoUCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus, Aurora
University of Colorado Anschutz Medical Campus, Aurora
University of Colorado Clinical and Translational Research Center, Aurora
University of Colorado Hospital, Aurora
District of ColumbiaGeorgetown University Medical Center, Washington D.C.
FloridaBRP- Hialeah Hospital, Hialeah
D&H Cancer Research Center LLC, Margate
Kendall South Medical Center, Miami
GeorgiaVelocity Clinical Research, Savannah, Savannah
IdahoHumphreys Diabetes Center, Boise
St. Luke's Idaho Elks Children's Pavilion, Boise
IllinoisNorthwestern Memorial Hospital, Chicago
Northwestern University Feinberg School of Medicine, Chicago
MarylandJohns Hopkins Hospital, Baltimore
Jadestone Clinical Research, Silver Spring
MassachusettsBrigham and Women's Hospital, Boston
Clinical Trials Center, Boston
Clinical Trials Hub, Boston
University of Massachusetts Chan Medical School, Worcester
MichiganUniversity of Michigan, Ann Arbor
Henry Ford Hospital, Detroit
New JerseyHoly Name Medical Center, Teaneck
North CarolinaDuke University - Main Hospital and Clinics, Durham
Duke Vaccine and Trials Unit, Durham
Duke Vaccine and Trials Unit, Durham
OhioUniversity of Cincinnati College of Medicine (UC Holmes), Cincinnati
University of Cincinnati Medical Center, Cincinnati
PennsylvaniaTRC, Pittsburgh
UPMC Division of Infectious Disease Clinic, Pittsburgh
UPMC Hillman Cancer Center, Pittsburgh
UPMC Presbyterian IDS, Pittsburgh
UPMC Presbyterian Shadyside, Pittsburgh
UPMC Shadyside, Pittsburgh
UPMC Shadyside IDS, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
Medical University of South Carolina Infectious Disease Clinic, Charleston
Medical University of South Carolina Investigational Drug Services (IDS), Charleston
Medical University of South Carolina Investigational Drug Services Pharmacy, Charleston
Medical University of South Carolina Research Nexus Clinic, Charleston
Medical University of South Carolina Translational Research Nexus Clinic and Laboratory, Charleston
TennesseeWest Tennessee Research Institute, Jackson
TexasBaylor Scott & White Health - Center for Advanced Heart and Lung Disease, Dallas
Baylor Scott & White Research Institute - Clinical Trials Office, Dallas
Baylor University Medical Center, Dallas
Zenos Clinical Research, Dallas
Cockrell Center for Advanced Therapeutics, Houston
Houston Methodist - Transplant Center, Houston
Houston Methodist Hospital, Houston
Memorial Hermann Hospital, Houston
Scurlock CCAT clinic, Houston
The University of Texas Health Science Center at Houston, Houston
UT Physicians, Houston
WashingtonFred Hutchinson Cancer Center, Seattle
Fred Hutchinson South Lake Union Clinic, Seattle
Seattle Rheumatology Associates, Seattle
Swedish Ambulatory Infusion Center- First Hill, Seattle
Swedish Cancer Institute Treatment Center, Seattle
Swedish Medical Center - First Hill Campus, Seattle
Swedish Medical Center- Innovative Therapeutics & Research Unit, Seattle
Swedish Organ Transplant and Liver Center, Seattle
University of Washington Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.