A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients with Coronavirus Disease 2019 (COVID-19) who are Not Hospitalized but are at Risk for Severe Disease
- Conditions
- Covid-19 at high risk of progression to severe illness.
- Registration Number
- 2024-517727-39-00
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
To compare the efficacy of ibuzatrelvir to placebo in nonhospitalized participants with COVID-19 who are at high risk of progression to severe illness.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 480
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12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
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Presence of risk factors for progression to severe COVID-19 at the time of screening based on age.
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Confirmed SARS-CoV-2 infection as determined by RAT in nasal specimen collected within 1 day prior to randomization.
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Participants must be unable or unwilling to take nirmatrelvir/ritonavir treatment.
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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.
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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.
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Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
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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).
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Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
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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.
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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.
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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.
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Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
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Ongoing Long COVID or PASC diagnosis.
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Severely immunocompromised
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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.
- Current use of any prohibited concomitant medication(s).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of participants with 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. Proportion of participants with 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.
- Secondary Outcome Measures
Name Time Method Time (days) to resolution of all targeted symptoms through Day 28. Time (days) to resolution of all targeted symptoms through Day 28.
Proportion of participants with CRPE from Day 1 to Week 24 Proportion of participants with CRPE from Day 1 to Week 24
Proportion of participants with PACE occurring from Day 29 to Week 24 Proportion of participants with PACE occurring from Day 29 to Week 24
Proportion of participants with Long COVID/PASC symptoms at Week 24, based on the Long COVID/PASC PRO. Proportion of participants with Long COVID/PASC symptoms at Week 24, based on the Long COVID/PASC PRO.
Trial Locations
- Locations (119)
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
Scroll for more (109 remaining)Applied Research Center of Arkansas🇺🇸Little Rock, Arkansas, United States