This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy,superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and incombination with remdesivir IV compared to remdesivir IV alone for the treatment ofsymptomatic COVID-19 in severely immunocompromised adult participants who arenon-hospitalized or are hospitalized for observation or study intervention administrationbut do not require supplemental oxygen for COVID-19.
The purpose of this clinical trial is to learn about a study medicine called Ibuzatrelvir
for the possible treatment of COVID-19 in immunocompromised patients. Immunocompromised
patients with COVID-19 have more difficulty fighting infections and are at risk for
persistent infections and progression to severe illness. This patient population may
benefit from extended antiviral treatment durations, or a combination of antiviral
therapies. This study will evaluate the efficacy and safety of ibuzatrelvir with and
without remdesivir compared with remdesivir alone for the treatment of symptomatic
COVID-19 in adult participants who are severely immunocompromised.
The study is seeking adult male and female participants who:
- Have a confirmed COVID-19 infection
- Are severely immunocompromised due to blood cancers, organ transplant, certain
medications or therapies
- Have experienced the onset of signs or symptoms of COVID-19 within the past 5 days
and are currently experiencing at least one of them.
All of the participants in this study will receive active treatment for COVID-19, and
will be randomized to one of three treatment arms. One-third will received remdesivir,
one-third will receive ibuzatrelvir, and one third will receive both remdesivir and
ibuzatrelvir. Ibuzatrelvir will be taken by mouth twice daily, and remdesivir is given as
an IV infusion daily. Placebos that look like the study medicines but do not have any
medication will be given to make the 3 treatment arms appear to be the same. The study
will compare the experiences of people receiving ibuzatrelvir with and without remdesivir
to those of the people who only received remdesivir for COVID-19. This will help decide
if ibuzatrelvir is safe and effective.
Participants will attend about 10 study visits over 24 weeks. During this time, they will
have:
- visits at the study clinic
- blood work
- swabs of the nose that are collected in the clinic and also by participants at home
- questionnaires
Drug: ibuzatrelvir
tablet
Drug: remdesivir
injection, for intravenous use
Other Name: veklury
Drug: placebo for ibuzatrelvir
tablet
Drug: placebo for remdesivir
injection, for intravenous use
Inclusion Criteria:
1. 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.
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 COVID-19, or current need for supplemental oxygen for treatment of COVID-19.
2. Receiving dialysis or have current kidney failure (ie, eGFR consistently <15
mL/min/1.73 m2)
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.
Hope Clinical Research, Inc.
Canoga Park, California, United States
Amicis Research Center - Granada Hills
Granada Hills, California, United States
UC Davis CTSC Clinical Research Center
Sacramento, California, United States
University of California Davis Health
Sacramento, California, United States
UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
BRP- Hialeah Hospital
Hialeah, Florida, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
Kendall South Medical Center
Miami, Florida, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Humphreys Diabetes Center
Boise, Idaho, United States
St. Luke's Idaho Elks Children's Pavilion
Boise, Idaho, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Jadestone Clinical Research
Silver Spring, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinical Trials Center
Boston, Massachusetts, United States
Clinical Trials Hub
Boston, Massachusetts, United States
Skylight Health Research - Burlington
Burlington, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Profound Research LLC
Farmington Hills, Michigan, United States
Revive Research Institute, Inc.
Farmington Hills, Michigan, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Cincinnati College of Medicine (UC Holmes)
Cincinnati, Ohio, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Zenos Clinical Research
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
UT Physicians
Houston, Texas, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Swedish Ambulatory Infusion Center- First Hill
Seattle, Washington, United States
Swedish Cancer Institute Treatment Center
Seattle, Washington, United States
Swedish Medical Center- Innovative Therapeutics & Research Unit
Seattle, Washington, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, United States
Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Sanatorio Sagrado Corazón
Buenos Aires, Argentina
UZ Brussel
Brussels, Brussels Capital, Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de, Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, West-vlaanderen, Belgium
Jules Bordet Institute
Anderlecht, Belgium
School of Medicine Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Unidade de Pesquisa Clínica em Vacinas da Faculdade de Medicina da Universidade Federal de Minas Ger
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre
Bairro Santa Cecília, Rio Grande do Sul, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, Brazil
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, Brazil
Rigshospitalet
Copenhagen, Capital Region, Denmark
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, Denmark
Aalborg Universitetshospital, Syd
Aalborg, North Denmark, Denmark
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
Hopital Claude Huriez - CHU de Lille
Lille, NORD, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
Dijon, France
Hôpital Saint Antoine
Paris, France
Hôpital Bichat - Claude-Bernard
Paris, France
Hôpital Saint-Louis
Paris, Île-de-France Region, France
TUM Klinikum
München, Bavaria, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Hamburg-Eppendorf I. Medizinische Klinik und Poliklinik
Hamburg, Germany
University General Hospital of Alexandroupoli
Alexandroupoli, Anatolikí Makedonía KAI Thráki, Greece
Evangelismos General Hospital of Athens
Athens, Attikí, Greece
Alexandra General Hospital of Athens
Athens, Attikí, Greece
General Hospital of Athens "Laiko"
Athens, Attikí, Greece
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
International University of Health and Welfare Narita Hospital
Narita, Chiba, Japan
Aso Iizuka Hospital
Iizuka, Fukuoka, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, Japan
National Center for Global Health and Medicine
Shinjuku, Tokyo, Japan
Tachikawa Hospital
Tachikawa, Tokyo, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
Nagasaki University Hospital
Nagasaki, Japan
Saga University Hospital
Saga, Japan
Radboudumc
Nijmegen, Netherlands
BRCR Medical Center - Ponce
Ponce, Puerto Rico
BRCR Global Puerto Rico
San Juan, Puerto Rico
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Banská Bystrica Region, Slovakia
Narodny ustav detskych chorob
Bratislava, Bratislava Region, Slovakia
Fakultna nemocnica Trnava
Trnava, Trnava Region, Slovakia
Narodny onkologicky ustav
Bratislava, Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
Michalovce, Slovakia
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea
Chonnam National University Hospital
Gwangju, Kwangju-kwangyǒkshi, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [barcelona], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], Spain
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra [pontevedra], Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Karolinska Universitetssjukhuset Huddinge
Huddinge, Sweden
Far Eastern Memorial Hospital
New Taipei City, NEW Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Acibadem Universitesi Atakent Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, Turkey (Türkiye)
Ibni Sina Hospital
Ankara, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, Turkey (Türkiye)
Kocaeli Üniversitesi
Kocaeli, Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye)
Karadeniz Technical University
Trabzon, Turkey (Türkiye)
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer