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

Status: Recruiting
Location: See all (101) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 for observation or study intervention administration but do not require supplemental oxygen for COVID-19.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
California
Hope Clinical Research, Inc.
RECRUITING
Canoga Park
Amicis Research Center - Granada Hills
NOT_YET_RECRUITING
Granada Hills
UC Davis CTSC Clinical Research Center
NOT_YET_RECRUITING
Sacramento
University of California Davis Health
NOT_YET_RECRUITING
Sacramento
Colorado
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
NOT_YET_RECRUITING
Aurora
University of Colorado Anschutz Medical Campus
NOT_YET_RECRUITING
Aurora
University of Colorado Clinical and Translational Research Center
NOT_YET_RECRUITING
Aurora
University of Colorado Hospital
NOT_YET_RECRUITING
Aurora
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
D&H Cancer Research Center LLC
RECRUITING
Margate
Georgia
Velocity Clinical Research, Savannah
RECRUITING
Savannah
Idaho
Humphreys Diabetes Center
NOT_YET_RECRUITING
Boise
Idaho Elk's Children's Pavillion
NOT_YET_RECRUITING
Boise
St. Luke's Children's
NOT_YET_RECRUITING
Boise
Illinois
Northwestern Memorial Hospital
NOT_YET_RECRUITING
Chicago
Northwestern University Division of Infectious Disease
NOT_YET_RECRUITING
Chicago
Northwestern University Feinberg School of Medicine
NOT_YET_RECRUITING
Chicago
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Clinical Trials Center
NOT_YET_RECRUITING
Boston
Clinical Trials Hub
NOT_YET_RECRUITING
Boston
Skylight Health Research - Burlington
RECRUITING
Burlington
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Maryland
Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Jadestone Clinical Research
RECRUITING
Silver Spring
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Profound Research LLC
RECRUITING
Farmington Hills
Revive Research Institute, Inc.
RECRUITING
Farmington Hills
North Carolina
Duke Main Hospital and Clinics
RECRUITING
Durham
Duke University - Main Hospital and Clinics
RECRUITING
Durham
Duke Vaccine and Trials Unit
RECRUITING
Durham
Duke Vaccine and Trials Unit
RECRUITING
Durham
New Jersey
Holy Name Medical Center
RECRUITING
Teaneck
Ohio
University of Cincinnati College of Medicine (UC Holmes)
RECRUITING
Cincinnati
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Texas
Zenos Clinical Research
RECRUITING
Dallas
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
Washington
Seattle Rheumatology Associates
NOT_YET_RECRUITING
Seattle
Swedish Ambulatory Infusion Center- First Hill
NOT_YET_RECRUITING
Seattle
Swedish Cancer Institute Treatment Center
NOT_YET_RECRUITING
Seattle
Swedish Medical Center - First Hill Campus
NOT_YET_RECRUITING
Seattle
Swedish Medical Center- Innovative Therapeutics & Research Unit
NOT_YET_RECRUITING
Seattle
Swedish Organ Transplant and Liver Center
NOT_YET_RECRUITING
Seattle
Other Locations
Belgium
Jules Bordet Institute
NOT_YET_RECRUITING
Anderlecht
AZ Sint-Jan Brugge-Oostende AV
NOT_YET_RECRUITING
Bruges
Université Libre de Bruxelles - Hôpital Erasme
NOT_YET_RECRUITING
Brussels
UZ Brussel
NOT_YET_RECRUITING
Brussels
Brazil
Hospital de Clinicas de Porto Alegre
NOT_YET_RECRUITING
Bairro Santa Cecília
CECIP - Centro de Estudos do Interior Paulista
NOT_YET_RECRUITING
Jaú
Icesp - Instituto Do Câncer Do Estado de São Paulo
RECRUITING
São Paulo
Denmark
Aarhus Universitetshospital, Skejby
RECRUITING
Aarhus
France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
NOT_YET_RECRUITING
Dijon
Hopital Claude Huriez - CHU de Lille
NOT_YET_RECRUITING
Lille
Hôpital Bichat - Claude-Bernard
NOT_YET_RECRUITING
Paris
Hôpital Saint Antoine
NOT_YET_RECRUITING
Paris
Hôpital Saint-Louis
NOT_YET_RECRUITING
Paris
Germany
Universitaetsklinikum Koeln
NOT_YET_RECRUITING
Cologne
TUM Klinikum
NOT_YET_RECRUITING
München
Greece
University General Hospital of Alexandroupoli
NOT_YET_RECRUITING
Alexandroupoli
Alexandra General Hospital of Athens
NOT_YET_RECRUITING
Athens
Evangelismos General Hospital of Athens
NOT_YET_RECRUITING
Athens
General Hospital of Athens Laiko
NOT_YET_RECRUITING
Athens
Japan
National Hospital Organization Kyushu Medical Center
RECRUITING
Fukuoka
Tokyo Medical University Hachioji Medical Center
RECRUITING
Hachiōji
Aso Iizuka Hospital
RECRUITING
Iizuka
Rinku General Medical Center
RECRUITING
Izumisano
Nagasaki University Hospital
RECRUITING
Nagasaki
International University of Health and Welfare Narita Hospital
RECRUITING
Narita
Saga University Hospital
RECRUITING
Saga
National Center for Global Health and Medicine
RECRUITING
Shinjuku
Tachikawa Hospital
RECRUITING
Tachikawa
Fujita Health University Hospital
RECRUITING
Toyoake
Puerto Rico
BRCR Medical Center - Ponce
NOT_YET_RECRUITING
Ponce
BRCR Global Puerto Rico
NOT_YET_RECRUITING
San Juan
Republic of Korea
Chonnam National University Hospital
RECRUITING
Gwangju
Gachon University Gil Medical Center
RECRUITING
Namdong-gu
Asan Medical Center
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
RECRUITING
Banská Bystrica
Narodny onkologicky ustav
RECRUITING
Bratislava
Narodny ustav detskych chorob
RECRUITING
Bratislava
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
RECRUITING
Michalovce
Fakultna nemocnica Trnava
RECRUITING
Trnava
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Parc de Salut Mar - Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Virgen de Valme
RECRUITING
Seville
CHUVI- Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Sweden
Karolinska Universitetssjukhuset Huddinge
NOT_YET_RECRUITING
Huddinge
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital
NOT_YET_RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
Turkey
Acibadem Universitesi Atakent Hastanesi
NOT_YET_RECRUITING
Istanbul
Kocaeli Üniversitesi
NOT_YET_RECRUITING
Kocaeli
Karadeniz Technical University
NOT_YET_RECRUITING
Trabzon
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2027-05-06
Participants
Target number of participants: 300
Treatments
Experimental: Ibuzatrelvir
Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir
Experimental: Ibuzatrelvir + Remdesivir
Participants will receive ibuzatrelvir orally twice a day + IV remdesivir
Experimental: Remdesivir
Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov