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.
Jadestone Clinical Research
Silver Spring, Maryland, United States
Skylight Health Research - Burlington
Burlington, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 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
West Tennessee Research Institute
Jackson, Tennessee, United States
Aso Iizuka Hospital
Iizuka, Fukuoka, Japan
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer