CD2H COVID-19

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

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

COVID-19 SARS-CoV-2 Infection

Eligibility

Eligible Ages: Over 12 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Arm	Description	Assigned 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 4119403, Arkansas 4099753 72205

National Institute of Clinical Research - Bakersfield
Bakersfield 5325738, California 5332921 93309

310 Clinical Research
Inglewood 5359488, California 5332921 90301

Long Beach Research Institute
Long Beach 5367929, California 5332921 90805

Downtown L.A. Research Center, Inc.
Los Angeles 5368361, California 5332921 90017

Clinica mi Salud by Focil Med
Oxnard 5380184, California 5332921 93030

FOMAT Medical Research
Oxnard 5380184, California 5332921 93030

Acclaim Clinical Research
San Diego 5391811, California 5332921 92120

Breathe Clear Institute for Sinus and Allergy Relief
Torrance 5403022, California 5332921 90503

Clinical Research of California
West Hills 8030162, California 5332921 91307

Paradigm Clinical Research, LLC
Wheat Ridge 5443948, Colorado 5417618 80033

Georgetown University Medical Center
Washington D.C. 4140963, District of Columbia 4138106 20007

Emerson Clinical Research Institute
Washington D.C. 4140963, District of Columbia 4138106 20009

Innovative Research of West Florida
Clearwater 4151316, Florida 4155751 33756

Invictus Clinical Research Group
Coconut Creek 4151455, Florida 4155751 33073

Hillcrest Medical Research LLC
DeLand 4152890, Florida 4155751 32720

Hillcrest Medical Research
DeLand 4152890, Florida 4155751 32720

Herco Medical and Research Center Inc
Flagami 4155529, Florida 4155751 33126

Qway Research LLC
Hialeah 4158476, Florida 4155751 33010

Sunbright Health Medical Centers
Homestead 4159050, Florida 4155751 33032

Bio-Medical Research LLC
Miami 4164138, Florida 4155751 33144

Kendall South Medical Center
Miami 4164138, Florida 4155751 33185

Global Health Research Center, Inc.
Miami Lakes 4164186, Florida 4155751 33016

Adult Medicine of Lake County, Inc.
Mt. Dora 4165069, Florida 4155751 32757

Innovation Medical Research Center
Palmetto Bay 4167634, Florida 4155751 33157

GCP Research, Global Clinical professionals
St. Petersburg 4171563, Florida 4155751 33705

Global Health Research Center - Tampa
Tampa 4174757, Florida 4155751 33615

Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville 4194474, Georgia 4197000 30214

Coastal Heritage Clinical Research
Hinesville 4200671, Georgia 4197000 31313

Koch Family Medicine
Morton 4902754, Illinois 4896861 61550

AMR Clinical
Oak Brook 4904277, Illinois 4896861 60523

UL International Travel Clinic
Louisville 4299276, Kentucky 6254925 40202

University of Louisville Hospital
Louisville 4299276, Kentucky 6254925 40202

University of Louisville School of Medicine
Louisville 4299276, Kentucky 6254925 40202

Centennial Medical Group
Columbia 4352053, Maryland 4361885 21045

Jadestone Clinical Research
Silver Spring 4369596, Maryland 4361885 20904

University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926 01655

Revival Research Institute, LLC
Dearborn 4990510, Michigan 5001836 48126

Henry Ford St. John Hospital
Grosse Pointe Woods 4994871, Michigan 5001836 48236

Mercury Street Medical Group, PLLC
Butte 5642934, Montana 5667009 59701

Velocity Clinical Research, Grand Island
Grand Island 5069297, Nebraska 5073708 68803

McGill Family Practice
Papillion 5074792, Nebraska 5073708 68046

Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151 89030

Prime Global Research
The Bronx 5110266, New York 5128638 10456

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467

Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112

Remington-Davis, Inc
Columbus 4509177, Ohio 5165418 43215

Preferred Primary Care Physicians
Uniontown 4561859, Pennsylvania 6254927 15401

WR-Clinsearch, LLC
Chattanooga 4612862, Tennessee 4662168 37421

AMR Clinical
Nashville 4644585, Tennessee 4662168 37203

Zenos Clinical Research
Dallas 4684888, Texas 4736286 75230

Southwest Family Medicine Associates
Dallas 4684888, Texas 4736286 75235

Southwest Mind and Body Care
Dallas 4684888, Texas 4736286 75235

Next Level Urgent Care
Houston 4699066, Texas 4736286 77057

Gulf Coast Clinical Research - Houston
Houston 4699066, Texas 4736286 77070

Mercury Clinical Research - Santa Clara Family Clinic
Houston 4699066, Texas 4736286 77087

The Crofoot Research Center
Houston 4699066, Texas 4736286 77098

Javara - Privia Medical Group North Texas - Stephenville
Stephenville 4734350, Texas 4736286 76401

Javara - Privia Medical Group Gulf Coast - Sugarland
Sugar Land 4734825, Texas 4736286 77478

Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball 4737094, Texas 4736286 77375

Alpine Research Organization
Clinton 5773001, Utah 5549030 84015

Eastside Research Associates
Redmond 5808079, Washington 5815135 98052

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