Phase
Condition
Covid-19
Treatment
placebo
ibuzatrelvir
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weightat screening.
Presence of risk factors for progression to severe COVID-19 at the time of screeningbased on age:
12 to 49 years of age with at least two risk factors, where one must bemoderate immunocompromise;
50 to 64 years of age with at least two risk factors;
65 to 74 years of age with at least one risk factor;
For participants 75 years of age or older, there are no requirements related torisk factors. The list of risk factors includes: BMI ≥30 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmentaldisorders; Sickle cell disease; Moderate immunosuppression.
Confirmed SARS-CoV-2 infection as determined by RAT in nasal specimen collectedwithin 1 day prior to randomization. Initial onset of symptoms attributable toCOVID-19 within 5 days prior to randomization and at least 1 of the specifiedsymptoms attributable to COVID-19 present on the day of randomization. Randomizationmust occur no later than the 5th day, where the onset of symptoms is the first day.
Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
Exclusion
Exclusion Criteria:
Current need or anticipated need for hospitalization within 24 hours, due to signsof severe COVID-19 illness (eg, SpO2 <94% on room air, respiratory rate >30breaths/minute, or lung infiltrates >50%) or due to other medical conditionsrequiring hospitalization in the opinion of the site investigator.
Receiving dialysis or have known severe renal impairment [ie, eGFR <30 mL/min/1.73m2 for adults or CrCl <30 mL/min for adolescents] within 6 months of the screeningvisit, using the serum creatinine-based CKD-EPI formula or the Cockroft Gault,respectively.
Active liver disease with AST or ALT >3 ULN, Total bilirubin ≥2 × ULN (for Gilbert'ssyndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liverfunction impairment with Class C per Child Pugh classification.
Suspected or confirmed concurrent active systemic infection other than COVID-19 thatmay interfere with the evaluation of response to the study intervention.
Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
Severely immunocompromised.
Any comorbidity requiring hospitalization and/or surgery within 7 days prior tostudy entry, or that is considered life threatening within 30 days prior to studyentry, as determined by the investigator.
Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.
Current use of any prohibited concomitant medication(s).
Has received any other antiviral for the treatment of COVID-19, includingremdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives [whichever is longer] prior to screening, or received convalescentCOVID-19 plasma within 12 months.
Received any dose of a COVID-19 vaccine within 4 months of randomization or expectedto receive one through Day 34.
Previous administration of an investigational product (drug or vaccine) within 30days or 5 half lives preceding the first dose of study intervention used in thisstudy (whichever is longer).
Prior participation in this clinical trial or any other clinical trial ofibuzatrelvir.
Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily members.
Study Design
Connect with a study center
Vancouver Infectious Diseases Centre
Vancouver, British Columbia V6Z 2C7
CanadaSite Not Available
Clinical Research of Ontario
Scarborough, Ontario M1S 4T7
CanadaSite Not Available
Diex Recherche Quebec
Quebec, G1V 4T3
CanadaSite Not Available
Kamezawa Clinic
Kasugai, Aichi 486-0817
JapanSite Not Available
International University of Health and Welfare Narita Hospital
Narita, Chiba 286-8520
JapanSite Not Available
Tashiro Endocrinology Clinic
Fukuoka-shi, Fukuoka 814-0153
JapanSite Not Available
Medical Corporation Kouhoukai Takagi Hospital
Okawa-shi, Fukuoka 831-0016
JapanSite Not Available
Nishioka Hospital
Sapporo, Hokkaido 062-0034
JapanSite Not Available
Terada Clinic Respiratory Medicine & General Practice
Himeji, Hyogo 670-0849
JapanSite Not Available
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki 300-0062
JapanSite Not Available
National Hospital Organization Okinawa Hospital
Ginowan, Okinawa 901-2214
JapanSite Not Available
Fukuwa Clinic
Chuo-ku, Tokyo 104-0031
JapanSite Not Available
Musashino Emergency Hospital
Kodaira-shi, Tokyo 187-0031
JapanSite Not Available
Swing Nozaki Clinic
Musashino-shi, Tokyo 180-0022
JapanSite Not Available
Yoshijima Hospital
Hiroshima, 730-0822
JapanSite Not Available
Rakuwakai Otowa Hospital
Kyoto, 607-8062
JapanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Applied Research Center of Arkansas
Little Rock, Arkansas 72205
United StatesActive - Recruiting
National Institute of Clinical Research - Bakersfield
Bakersfield, California 93309
United StatesActive - Recruiting
310 Clinical Research
Inglewood, California 90301
United StatesSite Not Available
Long Beach Research Institute
Long Beach, California 90805
United StatesActive - Recruiting
Downtown L.A. Research Center, Inc.
Los Angeles, California 90017
United StatesActive - Recruiting
Clinica mi Salud by Focil Med
Oxnard, California 93030
United StatesSite Not Available
FOMAT Medical Research
Oxnard, California 93030
United StatesSite Not Available
Tweedy Medical Group - Charity Health
S. Gate, California 90280
United StatesSite Not Available
Acclaim Clinical Research
San Diego, California 92120
United StatesActive - Recruiting
Breathe Clear Institute for Sinus and Allergy Relief
Torrance, California 90503
United StatesSite Not Available
Clinical Research of California
Walnut Creek, California 94598
United StatesSite Not Available
Clinical Research of California
West Hills, California 91307
United StatesActive - Recruiting
Paradigm Clinical Research, LLC
Wheat Ridge, Colorado 80033
United StatesSite Not Available
Emerson Clinical Research Institute
Washington, District of Columbia 20009
United StatesSite Not Available
Innovative Research of West Florida
Clearwater, Florida 33756
United StatesSite Not Available
Invictus Clinical Research Group
Coconut Creek, Florida 33073
United StatesActive - Recruiting
Alliance for Multispecialty Research, LLC
Coral Gables, Florida 33134
United StatesSite Not Available
Herco Medical and Research Center Inc
Coral Gables, Florida 33134
United StatesActive - Recruiting
Hillcrest Medical Research
DeLand, Florida 32720
United StatesActive - Recruiting
Hillcrest Medical Research LLC
DeLand, Florida 32720
United StatesActive - Recruiting
Universal Axon Clinical Research, LLC
Doral, Florida 33166
United StatesSite Not Available
Proactive Clinical Research,LLC
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Qway Research LLC
Hialeah, Florida 33010
United StatesSite Not Available
Sunbright Health Medical Centers
Homestead, Florida 33032
United StatesActive - Recruiting
Bio-Medical Research LLC
Miami, Florida 33144
United StatesActive - Recruiting
Kendall South Medical Center
Miami, Florida 33185
United StatesActive - Recruiting
Global Health Research Center, Inc.
Miami Lakes, Florida 33016
United StatesSite Not Available
Adult Medicine of Lake County, Inc.
Mount Dora, Florida 32757
United StatesSite Not Available
Innovation Medical Research Center
Palmetto Bay, Florida 33157
United StatesActive - Recruiting
DBC Research USA
Pembroke Pines, Florida 33029
United StatesSite Not Available
GCP Research, Global Clinical professionals
Saint Petersburg, Florida 33705
United StatesActive - Recruiting
Global Health Research Center - Tampa
Tampa, Florida 33615
United StatesSite Not Available
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia 30214
United StatesSite Not Available
Coastal Heritage Clinical Research
Hinesville, Georgia 31313
United StatesActive - Recruiting
Koch Family Medicine
Morton, Illinois 61550
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Oak Brook, Illinois 60523
United StatesActive - Recruiting
Centennial Medical Group
Columbia, Maryland 21045
United StatesSite Not Available
Jadestone Clinical Research
Silver Spring, Maryland 20904
United StatesSite Not Available
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United StatesSite Not Available
Revival Research Institute, LLC
Dearborn, Michigan 48126
United StatesActive - Recruiting
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan 48236
United StatesActive - Recruiting
Mercury Street Medical Group, PLLC
Butte, Montana 59701
United StatesActive - Recruiting
Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803
United StatesActive - Recruiting
McGill Family Practice
Papillion, Nebraska 68046
United StatesSite Not Available
Las Vegas Clinical Trials
North Las Vegas, Nevada 89030
United StatesActive - Recruiting
Prime Global Research
Bronx, New York 10456
United StatesSite Not Available
Monroe Biomedical Research
Monroe, North Carolina 28112
United StatesActive - Recruiting
Remington-Davis, Inc
Columbus, Ohio 43215
United StatesActive - Recruiting
Preferred Primary Care Physicians
Uniontown, Pennsylvania 15401
United StatesActive - Recruiting
WR-Clinsearch, LLC
Chattanooga, Tennessee 37421
United StatesActive - Recruiting
Alliance for Multispecialty Research, LLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
Southwest Family Medicine Associates
Dallas, Texas 75235
United StatesActive - Recruiting
Southwest Mind and Body Care
Dallas, Texas 75235
United StatesActive - Recruiting
Gulf Coast Clinical Research - Houston
Houston, Texas 77070
United StatesActive - Recruiting
Mercury Clinical Research - Santa Clara Family Clinic
Houston, Texas 77087
United StatesActive - Recruiting
Next Level Urgent Care
Houston, Texas 77057
United StatesActive - Recruiting
Santa Clara Family Clinic
Houston, Texas 77087
United StatesActive - Recruiting
The Crofoot Research Center
Houston, Texas 77098
United StatesActive - Recruiting
Epic Clinical Research
Lewisville, Texas 75057
United StatesSite Not Available
Javara - Privia Medical Group North Texas - Stephenville
Stephenville, Texas 76401
United StatesActive - Recruiting
Javara - Privia Medical Group Gulf Coast - Sugarland
Sugar Land, Texas 77478
United StatesActive - Recruiting
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas 77375
United StatesActive - Recruiting
North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas 77375
United StatesActive - Recruiting
Alpine Research Organization
Clinton, Utah 84015
United StatesActive - Recruiting
Eastside Research Associates
Redmond, Washington 98052
United StatesSite Not Available
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