Clinical trial NCT06679140: A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: COVID-19 SARS-CoV-2 Infection
Keywords: Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
COVID-19
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
ibuzatrelvir
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-11-07
Enrollment: 2330
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.


Eligibility criteria: Inclusion Criteria:

1. 12 to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
2. Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:

   1. 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
   2. 50 to 64 years of age with at least two risk factors;
   3. 65 to 74 years of age with at least one risk factor;
   4. For participants 75 years of age or older, there are no requirements related to risk factors.

   The list of risk factors includes:

   BMI ≥30 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.
3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.
4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir.

Exclusion Criteria:

1. Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \<94% on room air, respiratory rate \>30 breaths/minute, or lung infiltrates \>50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
2. Receiving dialysis or have known severe renal impairment \[ie, eGFR \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents\] within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.
3. Active liver disease with AST or ALT \>3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's syndrome, direct bilirubin \>ULN is exclusionary) within the past 3 months, or liver function impairment with Class C per Child Pugh classification.
4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
5. Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
6. Severely immunocompromised.
7. Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
8. 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.
9. Current use of any prohibited concomitant medication(s).
10. Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives \[whichever is longer\] prior to screening, or received convalescent COVID-19 plasma within 12 months.
11. Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
12. Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
13. Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
14. 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.

Primary outcomes:
measure: Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality
timeFrame: Day 1 through Day 28
Secondary outcomes:
measure: Time to all COVID-19 targeted symptoms resolution
timeFrame: Day 1 to Day 28
measure: Proportion of participants with post acute COVID-19 medical events
timeFrame: Day 29 to Week 24
measure: Proportion of participants with cardiovascular, renal and pulmonary events
timeFrame: Day 1 to Week 24
measure: Proportion of participants with Long COVID symptoms
timeFrame: Day 29 to Week 24
measure: Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal swabs
timeFrame: Day 1 through Day 34
measure: Time to SARS-CoV-2 RNA <LLOQ
timeFrame: Day 1 through Day 34
measure: Proportion of participants with SARS-CoV-2 RNA <LLOQ at each visit
timeFrame: Day 1 through Day 34
measure: Proportion of participants with rebound in SARS-CoV-2 RNA levels in nasopharyngeal swab
timeFrame: Day 10 and Day 14
measure: Proportion of participants with virologic and symptomatic rebound through Day 28
timeFrame: Day 10 to Day 34
measure: Proportion of participants with COVID-19-related hospitalization or all cause death through Day 28.
timeFrame: Day 1 to Day 28
measure: Number of days in hospital and ICU stay in participants with hospitalization (all-cause).
timeFrame: Day 1 to Week 24
measure: Number of medical visits through Week 24.
timeFrame: Day 1 to Week 24
measure: Proportion of participants with hospitalization (all-cause) or death (all-cause) through Week 24.
timeFrame: Day 1 to Week 24
measure: Time (days) to alleviation of all targeted symptoms through Day 28.
timeFrame: Day 1 to Day 28
measure: Proportion of participants with severe symptoms attributed to COVID-19 through Day 28.
timeFrame: Day 1 to Day 28
measure: Duration of each targeted COVID-19 sign/symptom.
timeFrame: Day 1 to Day 28
measure: Proportion of participants with symptomatic rebound through Day 28.
timeFrame: Day 1 to Day 28
measure: Incidence of treatment emergent adverse events
timeFrame: Day 1 to Day 34
measure: Incidence of SAEs and AEs leading to discontinuations.
timeFrame: Day 1 to Day 34
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: National Institute of Clinical Research - Bakersfield
state: California
city: Inglewood
country: United States
facility: 310 Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center, Inc.
state: California
city: Oxnard
country: United States
facility: Clinica mi Salud by Focil Med
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research
state: California
city: S. Gate
country: United States
facility: Tweedy Medical Group - Charity Health
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute for Sinus and Allergy Relief
state: California
city: Walnut Creek
country: United States
facility: Clinical Research of California
state: California
city: West Hills
country: United States
facility: Clinical Research of California
state: California
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research, LLC
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Coconut Creek
country: United States
facility: Invictus Clinical Research Group
state: Florida
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Coral Gables
country: United States
facility: Herco Medical and Research Center Inc
state: Florida
city: DeLand
country: United States
facility: Hillcrest Medical Research LLC
state: Florida
city: DeLand
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research,LLC
state: Florida
city: Hialeah
country: United States
facility: Qway Research LLC
state: Florida
city: Homestead
country: United States
facility: Sunbright Health Medical Centers
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center
state: Florida
city: Mount Dora
country: United States
facility: Adult Medicine of Lake County, Inc.
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research USA
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research, Global Clinical professionals
state: Florida
city: Tampa
country: United States
facility: Global Health Research Center - Tampa
state: Florida
city: Fayetteville
country: United States
facility: Javara - Privia Medical Group Georgia - Fayetteville
state: Georgia
city: Hinesville
country: United States
facility: Coastal Heritage Clinical Research
state: Georgia
city: Morton
country: United States
facility: Koch Family Medicine
state: Illinois
city: Oak Brook
country: United States
facility: AMR Clinical
state: Illinois
city: Columbia
country: United States
facility: Centennial Medical Group
state: Maryland
city: Silver Spring
country: United States
facility: Jadestone Clinical Research
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Dearborn
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Henry Ford St. John Hospital
state: Michigan
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Grand Island
country: United States
facility: Velocity Clinical Research, Grand Island
state: Nebraska
city: Papillion
country: United States
facility: McGill Family Practice
state: Nebraska
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Bronx
country: United States
facility: Prime Global Research
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Nashville
country: United States
facility: AMR Clinical
state: Tennessee
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Dallas
country: United States
facility: Southwest Mind and Body Care
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Houston
country: United States
facility: Gulf Coast Clinical Research - Houston
state: Texas
city: Houston
country: United States
facility: Mercury Clinical Research - Santa Clara Family Clinic
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: Stephenville
country: United States
facility: Javara - Privia Medical Group North Texas - Stephenville
state: Texas
city: Sugar Land
country: United States
facility: Javara - Privia Medical Group Gulf Coast - Sugarland
state: Texas
city: Tomball
country: United States
facility: Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Vancouver
country: Canada
facility: Vancouver Infectious Diseases Centre
state: British Columbia
city: Scarborough
country: Canada
facility: Clinical Research of Ontario
state: Ontario
city: Winchester
country: Canada
facility: Community Care Building
state: Ontario
city: Winchester
country: Canada
facility: Dundas Manor Nursing Home
state: Ontario
city: Winchester
country: Canada
facility: Winchester District Memorial Hospital
state: Ontario
city: Quebec
country: Canada
facility: Diex Recherche Quebec
city: Kasugai
country: Japan
facility: Kamezawa Clinic
state: Aichi
city: Narita
country: Japan
facility: International University of Health and Welfare Narita Hospital
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Tashiro Endocrinology Clinic
state: Fukuoka
city: Okawa-shi
country: Japan
facility: Medical Corporation Kouhoukai Takagi Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Nishioka Hospital
state: Hokkaido
city: Himeji
country: Japan
facility: Terada Clinic Respiratory Medicine & General Practice
state: Hyogo
city: Tsuchiura
country: Japan
facility: Tsuchiura Beryl Clinic
state: Ibaraki
city: Ginowan
country: Japan
facility: National Hospital Organization Okinawa Hospital
state: Okinawa
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Kodaira-shi
country: Japan
facility: Musashino Emergency Hospital
state: Tokyo
city: Musashino-shi
country: Japan
facility: Swing Nozaki Clinic
state: Tokyo
city: Hiroshima
country: Japan
facility: Yoshijima Hospital
city: Kyoto
country: Japan
facility: Rakuwakai Otowa Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: