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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
double blind with matching placebo

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ibuzatrelvir 		Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.
  • Drug: ibuzatrelvir
    ibuzatrelvir tablets
    Other names:
    • PF-07817883
Placebo Comparator
placebo 		placebo administered orally every 12 hours (twice daily) for 5 days.
  • Drug: placebo
    placebo tablets

Recruiting Locations

Applied Research Center of Arkansas
Little Rock, Arkansas 72205

Long Beach Research Institute
Long Beach, California 90805

Downtown L.A. Research Center, Inc.
Los Angeles, California 90017

Herco Medical and Research Center Inc
Coral Gables, Florida 33134

Hillcrest Medical Research LLC
DeLand, Florida 32720

Hillcrest Medical Research
DeLand, Florida 32720

Sunbright Health Medical Centers
Homestead, Florida 33032

Bio-Medical Research LLC
Miami, Florida 33144

Kendall South Medical Center
Miami, Florida 33185

Innovation Medical Research Center
Palmetto Bay, Florida 33157

GCP Research, Global Clinical professionals
Saint Petersburg, Florida 33705

Revival Research Institute, LLC
Dearborn, Michigan 48126

Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan 48236

Mercury Street Medical Group, PLLC
Butte, Montana 59701

Monroe Biomedical Research
Monroe, North Carolina 28112

Preferred Primary Care Physicians
Uniontown, Pennsylvania 15401

WR-Clinsearch, LLC
Chattanooga, Tennessee 37421

Alliance for Multispecialty Research, LLC
Nashville, Tennessee 37203

Next Level Urgent Care
Houston, Texas 77057

Santa Clara Family Clinic
Houston, Texas 77087

The Crofoot Research Center
Houston, Texas 77098

Javara - Privia Medical Group North Texas - Stephenville
Stephenville, Texas 76401

North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas 77375

Alpine Research Organization
Clinton, Utah 84015

More Details

NCT ID
NCT06679140
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.