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 but do not require supplementaloxygen 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.
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 lymphoma, 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 B-cell depleting therapies (eg, rituximab).
Exclusion Criteria:
1. Current need for supplemental oxygen for treatment of COVID-19.
2. Receiving dialysis or have known severe renal impairment within 6 months of the
screening visit
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 5333913, California 5332921, United States
UC Davis CTSC Clinical Research Center
Sacramento 5389489, California 5332921, United States
University of California Davis Health
Sacramento 5389489, California 5332921, United States
Georgetown University Medical Center
Washington D.C. 4140963, District of Columbia 4138106, United States
D&H Cancer Research Center LLC
Margate 4163407, Florida 4155751, United States
Velocity Clinical Research, Savannah
Savannah 4221552, Georgia 4197000, United States
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861, United States
Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885, United States
Jadestone Clinical Research
Silver Spring 4369596, Maryland 4361885, United States
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926, United States
Clinical Trials Center
Boston 4930956, Massachusetts 6254926, United States
Clinical Trials Hub
Boston 4930956, Massachusetts 6254926, United States
Skylight Health Research - Burlington
Burlington 4931737, Massachusetts 6254926, United States
University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926, United States
University of Michigan
Ann Arbor 4984247, Michigan 5001836, United States
Henry Ford Hospital
Detroit 4990729, Michigan 5001836, United States
Profound Research LLC
Farmington Hills 4992523, Michigan 5001836, United States
Revive Research Institute, Inc.
Farmington Hills 4992523, Michigan 5001836, United States
Holy Name Medical Center
Teaneck 5105262, New Jersey 5101760, United States
Duke Vaccine and Trials Unit
Durham 4464368, North Carolina 4482348, United States
Duke Vaccine and Trials Unit
Durham 4464368, North Carolina 4482348, United States
Duke Main Hospital and Clinics
Durham 4464368, North Carolina 4482348, United States
Duke University - Main Hospital and Clinics
Durham 4464368, North Carolina 4482348, United States
West Tennessee Research Institute
Jackson 4632595, Tennessee 4662168, United States
Zenos Clinical Research
Dallas 4684888, Texas 4736286, United States
Houston Methodist Hospital
Houston 4699066, Texas 4736286, United States
Jules Bordet Institute
Anderlecht 2803201, Belgium
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo 3448439, Brazil
Hopital Claude Huriez - CHU de Lille
Lille 2998324, NORD, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
Dijon 3021372, France
Hôpital Saint Antoine
Paris 2988507, France
Hôpital Bichat - Claude-Bernard
Paris 2988507, France
Hôpital Saint-Louis
Paris 2988507, Île-de-France Region 3012874, France
Universitaetsklinikum Koeln
Cologne 2886242, North Rhine-Westphalia 2861876, Germany
Fujita Health University Hospital
Toyoake 6822210, Aichi-ken 1865694, Japan
International University of Health and Welfare Narita Hospital
Narita 2111684, Chiba 2113014, Japan
Aso Iizuka Hospital
Iizuka 1861835, Fukuoka 1863958, Japan
Rinku General Medical Center
Izumisano 1861091, Osaka 1853904, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji 1863440, Tokyo 1850144, Japan
National Center for Global Health and Medicine
Shinjuku 11790353, Tokyo 1850144, Japan
Tachikawa Hospital
Tachikawa 11611487, Tokyo 1850144, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka 1863967, Japan
Nagasaki University Hospital
Nagasaki 1856177, Japan
Saga University Hospital
Saga 1853303, Japan
Fakultna nemocnica Trnava
Trnava 3057124, Trnava Region 3343958, Slovakia
Narodny onkologicky ustav
Bratislava 3060972, Slovakia
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea
Chonnam National University Hospital
Gwangju 1841811, Kwangju-kwangyǒkshi, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center
Seoul 1835848, Seoul-teukbyeolsi [seoul], South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña 3119841, A Coruña [LA Coruña], Spain
Hospital Universitario Reina Sofia
Córdoba 2519240, Andalusia 2593109, Spain
Hospital Germans Trias i Pujol
Badalona 3129028, Barcelona [barcelona], Spain
Hospital Universitari Vall d'Hebron
Barcelona 3128760, Barcelona [barcelona], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona 3128760, Catalunya [cataluña], Spain
Hospital Universitario La Paz
Madrid 3117735, Madrid, Comunidad de, Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo 3105976, Pontevedra [pontevedra], Spain
Hospital General Universitario Dr. Balmis
Alicante 2521978, Spain
Hospital Universitario Virgen de Valme
Seville 2510911, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City 1673820, Taiwan
Taichung Veterans General Hospital
Taichung 1668399, Taiwan
Taipei Veterans General Hospital
Taipei 1668341, Taiwan
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer