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
- Conditions
- COVID-19 SARS-CoV-2 Infection
- Interventions
- Drug: placebo
- Registration Number
- NCT06679140
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2330
-
12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
-
Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
- 12 to 49 years of age with at least two risk factors, where one must be moderate 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 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.
-
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.
-
Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
- 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.
- 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.
- 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.
- Suspected or confirmed concurrent active systemic infection other than COVID-19 that may 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 to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
- 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.
- Current use of any prohibited concomitant medication(s).
- 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.
- Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
- 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).
- Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ibuzatrelvir ibuzatrelvir Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days. placebo placebo placebo administered orally every 12 hours (twice daily) for 5 days.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Time to all COVID-19 targeted symptoms resolution Day 1 to Day 28 The difference in median time to sustained resolution of all targeted symptoms. Symptoms will be assessed through a daily electronic diary and include sore throat, cough, fever and diarrhea, among others.
Proportion of participants with post acute COVID-19 medical events Day 29 to Week 24 Medical events include cardiovascular events, pulmonary events, acute kidney disease and thromboembolic events.
Proportion of participants with cardiovascular, renal and pulmonary events Day 1 to Week 24 Medical events include cardiovascular events, pulmonary events, acute kidney disease and thromboembolic events.
Proportion of participants with Long COVID symptoms Day 29 to Week 24 The difference in proportions of patients with Long COVID symptoms at Week 24. Symptoms will be assessed through a weekly electronic diary.
Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal swabs Day 1 through Day 34 The viral load is measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR)
Time to SARS-CoV-2 RNA <LLOQ Day 1 through Day 34 Time needed to achieve a viral load below the lower limit of quantification of the essay used to measure it.
Proportion of participants with SARS-CoV-2 RNA <LLOQ at each visit Day 1 through Day 34 Proportion of participants with a SARS-CoV-2 viral load below the lower limit of quantification of the essay used to measure it.
Proportion of participants with rebound in SARS-CoV-2 RNA levels in nasopharyngeal swab Day 10 and Day 14 Virologic rebound is defined as:
at any follow up visit, a viral RNA level increase from End of Treatment (Day 5) of ≥ 1.0 log10 copies/mL resulting in a viral RNA level ≥3.0 log10 copies/mL.Proportion of participants with virologic and symptomatic rebound through Day 28 Day 10 to Day 34 symptoms rebound is defined as: after achieving short symptom recovery (the first day of at least two consecutive diary entries where all targeted symptoms are absent), symptom rebound is the first day of at least two consecutive diary entries after Day 5 where there is any targeted symptom (regardless of severity), or when a participant is hospitalized after symptom recovery.
Proportion of participants with COVID-19-related hospitalization or all cause death through Day 28. Day 1 to Day 28 Number of days in hospital and ICU stay in participants with hospitalization (all-cause). Day 1 to Week 24 Number of medical visits through Week 24. Day 1 to Week 24 medical visits include emergency department visits, hospitalizations, visits to the general practitioner and specialist.
Proportion of participants with hospitalization (all-cause) or death (all-cause) through Week 24. Day 1 to Week 24 Time (days) to alleviation of all targeted symptoms through Day 28. Day 1 to Day 28 The difference in median time to sustained alleviation of all targeted symptoms. Symptoms will be assessed through a daily electronic diary and include sore throat, cough, fever and diarrhea, among others.
Proportion of participants with severe symptoms attributed to COVID-19 through Day 28. Day 1 to Day 28 Participants are required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline is counted as severe. Percentage of participants with severe Covid-19 signs and symptoms is reported.
Duration of each targeted COVID-19 sign/symptom. Day 1 to Day 28 Duration of each targeted COVID-19 sign/symptom is defined as (First Date when the symptom achieved sustained alleviation/resolved)-(First Dose Date) + I for each participant with baseline severity of mild, moderate, or severe. Missing severity at baseline will be treated as mild.
Proportion of participants with symptomatic rebound through Day 28. Day 1 to Day 28 Definition of symptomatic rebound: After achieving short symptom recovery (the first day of at least two consecutive diary entries where all targeted symptoms are absent), symptom rebound is the first day of at least two consecutive diary entries after Day 5 where there is any targeted symptom (regardless of severity), or when a participant is hospitalized after symptom recovery
Incidence of treatment emergent adverse events Day 1 to Day 34 An adverse event (AE) is any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) is any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE is considered as TEAE if the event started on or after start date of study intervention.
Incidence of SAEs and AEs leading to discontinuations. Day 1 to Day 34
Trial Locations
- Locations (77)
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
Clinical Research of California
🇺🇸West Hills, 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
🇺🇸Nashville, Tennessee, 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
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
McGill Family Practice
🇺🇸Papillion, Nebraska, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
Prime Global Research
🇺🇸Bronx, New York, 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
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
Gulf Coast Clinical Research - Houston
🇺🇸Houston, Texas, United States
Mercury Clinical Research - 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
Clinical Research of Ontario
🇨🇦Scarborough, Ontario, Canada
Diex Recherche Quebec
🇨🇦Quebec, Canada
Kamezawa Clinic
🇯🇵Kasugai, Aichi, Japan
International University of Health and Welfare Narita Hospital
🇯🇵Narita, Chiba, Japan
Tashiro Endocrinology Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Medical Corporation Kouhoukai Takagi Hospital
🇯🇵Okawa-shi, Fukuoka, Japan
Nishioka Hospital
🇯🇵Sapporo, Hokkaido, Japan
Terada Clinic Respiratory Medicine & General Practice
🇯🇵Himeji, Hyogo, Japan
Tsuchiura Beryl Clinic
🇯🇵Tsuchiura, Ibaraki, Japan
National Hospital Organization Okinawa Hospital
🇯🇵Ginowan, Okinawa, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Musashino Emergency Hospital
🇯🇵Kodaira-shi, Tokyo, Japan
Swing Nozaki Clinic
🇯🇵Musashino-shi, Tokyo, Japan
Yoshijima Hospital
🇯🇵Hiroshima, Japan
Rakuwakai Otowa Hospital
🇯🇵Kyoto, Japan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan