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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 (129) 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
RECRUITING
Granada Hills
UC Davis CTSC Clinical Research Center
RECRUITING
Sacramento
University of California Davis Health
RECRUITING
Sacramento
Colorado
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
RECRUITING
Aurora
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
University of Colorado Clinical and Translational Research Center
RECRUITING
Aurora
University of Colorado Hospital
RECRUITING
Aurora
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
BRP- Hialeah Hospital
RECRUITING
Hialeah
D&H Cancer Research Center LLC
RECRUITING
Margate
Kendall South Medical Center
RECRUITING
Miami
Georgia
Velocity Clinical Research, Savannah
RECRUITING
Savannah
Idaho
Humphreys Diabetes Center
RECRUITING
Boise
St. Luke's Idaho Elks Children's Pavilion
RECRUITING
Boise
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Northwestern University Feinberg School of Medicine
RECRUITING
Chicago
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Clinical Trials Center
RECRUITING
Boston
Clinical Trials Hub
RECRUITING
Boston
Skylight Health Research - Burlington
RECRUITING
Burlington
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Jadestone Clinical Research
RECRUITING
Silver Spring
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Profound Research LLC
RECRUITING
Farmington Hills
Revive Research Institute, Inc.
RECRUITING
Farmington Hills
North Carolina
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
Pennsylvania
TRC
NOT_YET_RECRUITING
Pittsburgh
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
UPMC Division of Infectious Disease Clinic
NOT_YET_RECRUITING
Pittsburgh
UPMC Hillman Cancer Center
NOT_YET_RECRUITING
Pittsburgh
UPMC Presbyterian IDS
NOT_YET_RECRUITING
Pittsburgh
UPMC Presbyterian Shadyside
NOT_YET_RECRUITING
Pittsburgh
UPMC Shadyside
NOT_YET_RECRUITING
Pittsburgh
Tennessee
West Tennessee Research Institute
RECRUITING
Jackson
Texas
Zenos Clinical Research
RECRUITING
Dallas
Houston Methodist Hospital
RECRUITING
Houston
Memorial Hermann Hospital
RECRUITING
Houston
The University of Texas Health Science Center at Houston
RECRUITING
Houston
UT Physicians
RECRUITING
Houston
Washington
Seattle Rheumatology Associates
RECRUITING
Seattle
Swedish Ambulatory Infusion Center- First Hill
RECRUITING
Seattle
Swedish Cancer Institute Treatment Center
RECRUITING
Seattle
Swedish Medical Center - First Hill Campus
RECRUITING
Seattle
Swedish Medical Center- Innovative Therapeutics & Research Unit
RECRUITING
Seattle
Swedish Organ Transplant and Liver Center
RECRUITING
Seattle
Other Locations
Argentina
Sanatorio Sagrado Corazón
RECRUITING
Buenos Aires
Instituto Médico Río Cuarto
RECRUITING
Río Cuarto
Belgium
Jules Bordet Institute
RECRUITING
Anderlecht
AZ Sint-Jan Brugge-Oostende AV
RECRUITING
Bruges
Université Libre de Bruxelles - Hôpital Erasme
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
Brazil
Hospital de Clinicas de Porto Alegre
RECRUITING
Bairro Santa Cecília
School of Medicine Federal University of Minas Gerais
RECRUITING
Belo Horizonte
Hospital e Maternidade Celso Pierro
NOT_YET_RECRUITING
Campinas
Centro Médico São Francisco
NOT_YET_RECRUITING
Curitiba
Hospital Nossa Senhora das Graças
NOT_YET_RECRUITING
Curitiba
CECIP - Centro de Estudos do Interior Paulista
NOT_YET_RECRUITING
Jaú
Instituto Nacional de Infectologia Evandro Chagas
NOT_YET_RECRUITING
Rio De Janeiro
Icesp - Instituto Do Câncer Do Estado de São Paulo
RECRUITING
São Paulo
Denmark
Aalborg Universitetshospital, Syd
RECRUITING
Aalborg
Aarhus Universitetshospital, Skejby
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Odense Universitetshospital
RECRUITING
Odense
France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
RECRUITING
Dijon
Hopital Claude Huriez - CHU de Lille
RECRUITING
Lille
Hôpital Bichat - Claude-Bernard
RECRUITING
Paris
Hôpital Saint Antoine
RECRUITING
Paris
Hôpital Saint-Louis
RECRUITING
Paris
Germany
Universitaetsklinikum Koeln
RECRUITING
Cologne
UKE Hamburg
NOT_YET_RECRUITING
Hamburg
TUM Klinikum
RECRUITING
München
Greece
University General Hospital of Alexandroupoli
RECRUITING
Alexandroupoli
Alexandra General Hospital of Athens
RECRUITING
Athens
Evangelismos General Hospital of Athens
RECRUITING
Athens
General Hospital of Athens Laiko
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
Mexico
Fundación Santos y de la Garza Evia I.B.P
NOT_YET_RECRUITING
San Pedro Garza García
Netherlands
Radboudumc
NOT_YET_RECRUITING
Nijmegen
Puerto Rico
BRCR Medical Center - Ponce
NOT_YET_RECRUITING
Ponce
Canas Medical Center
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
CHUAC-Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
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
RECRUITING
Huddinge
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
Turkey
Hacettepe Universite Hastaneleri
RECRUITING
Ankara
Ibni Sina Hospital
RECRUITING
Ankara
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
NOT_YET_RECRUITING
Gaziantep
Acibadem Universitesi Atakent Hastanesi
RECRUITING
Istanbul
Kocaeli Üniversitesi
RECRUITING
Kocaeli
Sakarya Training and Research Hospital
RECRUITING
Sakarya
Karadeniz Technical University
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