Clinical Trials List
2025-04-01 - 2027-11-30
Phase III
Recruiting5
ICD-10B34.0
Adenovirus infection, unspecified
ICD-10B97.0
Adenovirus as the cause of diseases classified elsewhere
ICD-9079.0
Adenovirus infection in conditions classified elsewhere and of unspecified site
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS
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Sponsor
PFIZER LIMITED
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih Han Juan Division of Infectious Disease
- Ping-Feng Wu Division of Infectious Disease
- 陳昕白 Division of Infectious Disease
- Chien Chuang Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution 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 ≥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
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 <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.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
2330 participants
