The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe inadults and adolescents with COVID-19 who do not need to be in the hospital but who are athigh risk for progression to severe disease. Eligible participants will be randomlyassigned (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 ofthe study is around 6 months.
Not Provided
Drug: ibuzatrelvir
ibuzatrelvir tablets
Other Name: PF-07817883
Drug: placebo
placebo tablets
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.
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
National Institute of Clinical Research - Bakersfield
Bakersfield, California, United States
310 Clinical Research
Inglewood, California, United States
Long Beach Research Institute
Long Beach, California, United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, United States
Clinica mi Salud by Focil Med
Oxnard, California, United States
FOMAT Medical Research
Oxnard, California, United States
Tweedy Medical Group - Charity Health
S. Gate, California, United States
Acclaim Clinical Research
San Diego, California, United States
Breathe Clear Institute for Sinus and Allergy Relief
Torrance, California, United States
Paradigm Clinical Research, LLC
Wheat Ridge, Colorado, United States
Emerson Clinical Research Institute
Washington, District of Columbia, United States
Innovative Research of West Florida
Clearwater, Florida, United States
Invictus Clinical Research Group
Coconut Creek, Florida, United States
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, United States
Herco Medical and Research Center Inc
Coral Gables, Florida, United States
Hillcrest Medical Research LLC
DeLand, Florida, United States
Hillcrest Medical Research
DeLand, Florida, United States
Universal Axon Clinical Research, LLC
Doral, Florida, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Qway Research LLC
Hialeah, Florida, United States
Sunbright Health Medical Centers
Homestead, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Bio-Medical Research LLC
Miami, Florida, United States
Kendall South Medical Center
Miami, Florida, United States
Adult Medicine of Lake County, Inc.
Mount Dora, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
GCP Research, Global Clinical professionals
Saint Petersburg, Florida, United States
Global Health Research Center - Tampa
Tampa, Florida, United States
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia, United States
Coastal Heritage Clinical Research
Hinesville, Georgia, United States
Koch Family Medicine
Morton, Illinois, United States
Alliance for Multispecialty Research, LLC
Oak Brook, Illinois, United States
Centennial Medical Group
Columbia, Maryland, United States
Jadestone Clinical Research
Silver Spring, Maryland, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Revival Research Institute, LLC
Dearborn, Michigan, United States
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Remington-Davis, Inc
Columbus, Ohio, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, United States
Alliance for Multispecialty Research, LLC
Nashville, Tennessee, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Southwest Mind and Body Care
Dallas, Texas, United States
Next Level Urgent Care
Houston, Texas, United States
Santa Clara Family Clinic
Houston, Texas, United States
The Crofoot Research Center
Houston, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
Javara - Privia Medical Group North Texas - Stephenville
Stephenville, Texas, United States
Javara - Privia Medical Group Gulf Coast - Sugarland
Sugar Land, Texas, United States
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas, United States
Alpine Research Organization
Clinton, Utah, United States
Eastside Research Associates
Redmond, Washington, United States
Vancouver Infectious Diseases Centre
Vancouver, British Columbia, Canada
Kamezawa Clinic
Kasugai, Aichi, Japan
Terada Clinic Respiratory Medicine & General Practice
Himeji, Hyogo, Japan
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Swing Nozaki Clinic
Musashino-shi, Tokyo, Japan
Rakuwakai Otowa Hospital
Kyoto, Japan
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer