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
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
Sex
ALL
Min age
12 Years
Max age
—
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 ≥35 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 or NP 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 \[ie, eGFR consistently \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents\], 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. History of hypersensitivity or other contraindication to any of the components of the study interventions.
9. 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.
10. 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.
12.Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
13.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).
14.Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
15.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 outcome measure(s)
Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality — Day 1 through Day 28 The difference in proportions of patients requiring COVID 19 related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.
Trial sites (252)
Facility
City
Region
Status
Applied Research Center of Arkansas
Little Rock
Arkansas
Recruiting
National Institute of Clinical Research - Bakersfield
Bakersfield
California
Recruiting
Velocity Clinical Research, Huntington Park
Huntington Park
California
Recruiting
310 Clinical Research
Inglewood
California
Recruiting
Long Beach Research Institute
Long Beach
California
Recruiting
Long Beach Clinical Trials
Long Beach
California
Recruiting
Pacific Clinical Studies Inc.
Los Alamitos
California
Recruiting
Downtown L.A. Research Center, Inc.
Los Angeles
California
Recruiting
Clinica mi Salud by Focil Med
Oxnard
California
Recruiting
FOMAT Medical Research
Oxnard
California
Recruiting
Paradigm Clinical Research, LLC
Redding
California
Recruiting
Acclaim Clinical Research
San Diego
California
Recruiting
Tweedy Medical Group - Charity Health
South Gate
California
Recruiting
Breathe Clear Institute for Sinus and Allergy Relief
Torrance
California
Recruiting
Paradigm Clinical Research, LLC
Wheat Ridge
Colorado
Recruiting
Georgetown University Medical Center
Washington D.C.
District of Columbia
Recruiting
Emerson Clinical Research Institute
Washington D.C.
District of Columbia
Recruiting
Innovative Research of West Florida
Clearwater
Florida
Recruiting
Invictus Clinical Research Group
Coconut Creek
Florida
Recruiting
Hillcrest Medical Research LLC
DeLand
Florida
Recruiting
Hillcrest Medical Research
DeLand
Florida
Recruiting
Universal Axon Clinical Research, LLC
Doral
Florida
Recruiting
Herco Medical and Research Center Inc
Flagami
Florida
Recruiting
Proactive Clinical Research,LLC
Fort Lauderdale
Florida
Recruiting
C & R Research Services USA
Fort Myers
Florida
Recruiting
Qway Research LLC
Hialeah
Florida
Recruiting
Sunbright Health Medical Centers
Homestead
Florida
Recruiting
Infinite Clinical Research
Miami
Florida
Recruiting
Bio-Medical Research LLC
Miami
Florida
Recruiting
Kendall South Medical Center
Miami
Florida
Recruiting
Global Health Research Center, Inc.
Miami Lakes
Florida
Recruiting
Adult Medicine of Lake County, Inc.
Mt. Dora
Florida
Recruiting
Innovation Medical Research Center
Palmetto Bay
Florida
Recruiting
DBC Research USA
Pembroke Pines
Florida
Recruiting
GCP , Global Clinical Professionals
St. Petersburg
Florida
Recruiting
Global Health Research Center - Tampa
Tampa
Florida
Recruiting
The Hope Clinic of Emory University
Decatur
Georgia
Recruiting
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville
Georgia
Recruiting
Coastal Heritage Clinical Research
Hinesville
Georgia
Recruiting
Velocity Clinical Research, Savannah
Savannah
Georgia
Recruiting
+ 212 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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