Last updated 15 days ago
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
300 patients around the world
Available in United States, Brazil
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
Pfizer
1Research sites
300Patients around the world
This study is for people with
Covid-19
Covid-19 pneumonia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 18 years of age or older at screening.Confirmed SARS-CoV-2 infection as determined by RAT 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.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.
- Current need for supplemental oxygen for treatment of COVID-19.Receiving dialysis or have known severe renal impairment within 6 months of the screening visit.Active liver disease.History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.Any medical or psychiatric condition including recent 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.Has received any other antiviral for the treatment of the current COVID-19 infection.Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).Current or previous administration of an investigational product within 30 days or 5 half lives preceding the first dose of study intervention used in this study.Prior participation in this trial or any clinical trial of ibuzatrelvir.Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.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.
Sites
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
SponsorPfizer
Study typeInterventional
Conditions
Covid-19 pneumonia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07013474
