Clinical Trials List
Protocol NumberC5091017
NCT Number(ClinicalTrials.gov Identfier)NCT06679140
Active
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, phase 3, double-blind, 2-arm trial investigated the efficacy and safety of oral ibuzatarlevil compared to placebo in non-hospitalized symptomatic adults and adolescents with COVID-19 at high risk of developing severe illness.
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Sponsor
Pfizer Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/04
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
- Ping-Feng Wu Division of Infectious Disease
- Chih Han Juan Division of Infectious Disease
- Chien Chuang Division of Infectious Disease
- 陳昕白 Division of Infectious Disease
- 劉思妤 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Horng-Chyuan Lin
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Novel Coronavirus Disease
Objectives
This trial aims to evaluate the efficacy and safety of ibuzatrelvir in treating non-hospitalized symptomatic COVID-19 patients in adults and adolescents at risk of developing severe illness.
Test Drug
PF-07817883(IBUZATRELVIR)
Active Ingredient
PF-07817883(IBUZATRELVIR)
Dosage Form
Tablets
Dosage
300 mg
Endpoints
The proportion of subjects who visited the emergency room for COVID-19 by day 28 and received additional oxygen, COVID-19 antiviral drugs, or intravenous (IV) treatment (e.g., fluid infusion, antibiotics, or corticosteroids), or who died from all causes.
Inclution Criteria
Inclusion Criteria
Age and Risk Factors:
1. Participants must be 12 to under 18 years of age and weigh at least 40 kg at screening, or 18 years of age or older with no weight restriction.
• Women of childbearing potential (WOCBP) who consent to the use of highly effective contraception may be included. See Section 8, Contraceptive Use, for requirements.
2. Based on age, participants must have risk factors for developing severe COVID-19 at screening:
a. 12 to 49 years of age with at least two risk factors, one of which must be moderate immunodeficiency;
b. 50 to 64 years of age with at least two risk factors;
c. 65 to 74 years of age with at least one risk factor;
d. For participants aged 75 years or older, there are no risk factor requirements.
The list of risk factors includes:
• BMI ≥ 30 kg/m2;
• Current smoker (having smoked within the past 30 days) and a lifetime history of at least 100 cigarettes;
• Chronic lung disease (i.e., bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, interstitial lung disease, history of pulmonary embolism, pulmonary hypertension);
• Asthma requiring daily prescription therapy;
• Cardiovascular disease, defined as any of the following histories: coronary artery disease, cardiomyopathy, myocardial infarction, stroke, transient ischemic attack, heart failure, angina pectoris with prescription nitroglycerin, coronary artery bypass surgery, cardiac catheterization, carotid endarterectomy, and aortic bypass surgery;
• Type 1 or type 2 diabetes;
• Mild to moderate renal impairment, provided the participant does not meet exclusion criterion 2;
• Neurodevelopmental disorders (e.g., cerebral palsy, Down syndrome) or other conditions leading to medical complications (e.g., genetic or metabolic syndromes and severe congenital abnormalities), provided that the participant's cognitive function is sufficient to obtain informed consent and complete trial procedures (e.g., log);
• Sickle cell disease;
• Moderate immunosuppression
Disease characteristics:
3. Confirmed infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via rapid screening from a nasal sample collected within 1 day prior to randomization. Initial symptoms of COVID-19 must have appeared within 5 days prior to randomization, and at least one specific symptom attributable to COVID-19 must be present on the day of randomization. Randomization must be performed no later than day 5, with symptom onset on day 1.
4. Participants must be unable or unwilling to receive nirmatrelvir/ritonavir treatment.
Age and Risk Factors:
1. Participants must be 12 to under 18 years of age and weigh at least 40 kg at screening, or 18 years of age or older with no weight restriction.
• Women of childbearing potential (WOCBP) who consent to the use of highly effective contraception may be included. See Section 8, Contraceptive Use, for requirements.
2. Based on age, participants must have risk factors for developing severe COVID-19 at screening:
a. 12 to 49 years of age with at least two risk factors, one of which must be moderate immunodeficiency;
b. 50 to 64 years of age with at least two risk factors;
c. 65 to 74 years of age with at least one risk factor;
d. For participants aged 75 years or older, there are no risk factor requirements.
The list of risk factors includes:
• BMI ≥ 30 kg/m2;
• Current smoker (having smoked within the past 30 days) and a lifetime history of at least 100 cigarettes;
• Chronic lung disease (i.e., bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, interstitial lung disease, history of pulmonary embolism, pulmonary hypertension);
• Asthma requiring daily prescription therapy;
• Cardiovascular disease, defined as any of the following histories: coronary artery disease, cardiomyopathy, myocardial infarction, stroke, transient ischemic attack, heart failure, angina pectoris with prescription nitroglycerin, coronary artery bypass surgery, cardiac catheterization, carotid endarterectomy, and aortic bypass surgery;
• Type 1 or type 2 diabetes;
• Mild to moderate renal impairment, provided the participant does not meet exclusion criterion 2;
• Neurodevelopmental disorders (e.g., cerebral palsy, Down syndrome) or other conditions leading to medical complications (e.g., genetic or metabolic syndromes and severe congenital abnormalities), provided that the participant's cognitive function is sufficient to obtain informed consent and complete trial procedures (e.g., log);
• Sickle cell disease;
• Moderate immunosuppression
Disease characteristics:
3. Confirmed infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via rapid screening from a nasal sample collected within 1 day prior to randomization. Initial symptoms of COVID-19 must have appeared within 5 days prior to randomization, and at least one specific symptom attributable to COVID-19 must be present on the day of randomization. Randomization must be performed no later than day 5, with symptom onset on day 1.
4. Participants must be unable or unwilling to receive nirmatrelvir/ritonavir treatment.
Exclusion Criteria
Exclusion Criteria
Participants are ineligible to participate in this trial if they meet any of the following criteria:
Medical Conditions:
1. Currently requiring or expected to require hospitalization within 24 hours due to severe COVID-19 symptoms (e.g., indoor air oxygen saturation SpO2 < 94%, respiratory rate > 30 breaths/min, or lung infiltration > 50%), or other medical conditions deemed necessary by the trial administrator.
2. Having undergone dialysis within the 6 months prior to screening or having known severe renal impairment [i.e., estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² for adults, and creatinine clearance (CrCl) < 30 mL/min for adolescents]. 3. Active liver disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3 times the upper limit of normal (ULN) or total bilirubin ≥ 2 times the upper limit of normal (excluding direct bilirubin > ULN for Gilbert's syndrome), or hepatic impairment classified as Child-Pugh grade C.
4. Suspected or confirmed non-COVID-19 concurrent active systemic infection that may interfere with the assessment of response to experimental interventional therapy.
5. Diagnosis of prolonged COVID-19 or SARS-CoV-2 acute post-infection sequelae.
6. Severe immunodeficiency.
7. Having any comorbidities requiring hospitalization and/or surgery within 7 days prior to enrollment in the trial, or having any life-threatening comorbidities as determined by the trial administrator within 30 days prior to enrollment in the trial.
8. Any medical or psychiatric condition that may increase the risk of trial participation, including recent (within the past year) or current suicidal ideation/behavior or abnormal laboratory tests, or being deemed unsuitable for trial participation by the trial administrator.
Previous/Concomitant Therapies:
9. Currently using any prohibited medications.
10. Having received any other antiviral drugs 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 having received convalescent COVID-19 plasma within 12 months.
11. Received any dose of COVID-19 vaccine within the 4 months prior to randomization, or is expected to receive a COVID-19 vaccine before day 34 of the trial.
Previous/Concurrent Clinical Trial Experience:
12. Previously used any investigational drug (medicine or vaccine) within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of the investigational drug in this trial.
13. Previously participated in this clinical trial or any other ibuzatrelvir clinical trial.
Other Exclusion Criteria:
14. Staff of the trial principal investigator's institution directly involved in the execution of the trial and their families, staff of the trial institution otherwise supervised by the trial principal investigator, and staff of the trial sponsor and their representatives directly involved in the execution of the trial and their respective families.
Participants are ineligible to participate in this trial if they meet any of the following criteria:
Medical Conditions:
1. Currently requiring or expected to require hospitalization within 24 hours due to severe COVID-19 symptoms (e.g., indoor air oxygen saturation SpO2 < 94%, respiratory rate > 30 breaths/min, or lung infiltration > 50%), or other medical conditions deemed necessary by the trial administrator.
2. Having undergone dialysis within the 6 months prior to screening or having known severe renal impairment [i.e., estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² for adults, and creatinine clearance (CrCl) < 30 mL/min for adolescents]. 3. Active liver disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3 times the upper limit of normal (ULN) or total bilirubin ≥ 2 times the upper limit of normal (excluding direct bilirubin > ULN for Gilbert's syndrome), or hepatic impairment classified as Child-Pugh grade C.
4. Suspected or confirmed non-COVID-19 concurrent active systemic infection that may interfere with the assessment of response to experimental interventional therapy.
5. Diagnosis of prolonged COVID-19 or SARS-CoV-2 acute post-infection sequelae.
6. Severe immunodeficiency.
7. Having any comorbidities requiring hospitalization and/or surgery within 7 days prior to enrollment in the trial, or having any life-threatening comorbidities as determined by the trial administrator within 30 days prior to enrollment in the trial.
8. Any medical or psychiatric condition that may increase the risk of trial participation, including recent (within the past year) or current suicidal ideation/behavior or abnormal laboratory tests, or being deemed unsuitable for trial participation by the trial administrator.
Previous/Concomitant Therapies:
9. Currently using any prohibited medications.
10. Having received any other antiviral drugs 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 having received convalescent COVID-19 plasma within 12 months.
11. Received any dose of COVID-19 vaccine within the 4 months prior to randomization, or is expected to receive a COVID-19 vaccine before day 34 of the trial.
Previous/Concurrent Clinical Trial Experience:
12. Previously used any investigational drug (medicine or vaccine) within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of the investigational drug in this trial.
13. Previously participated in this clinical trial or any other ibuzatrelvir clinical trial.
Other Exclusion Criteria:
14. Staff of the trial principal investigator's institution directly involved in the execution of the trial and their families, staff of the trial institution otherwise supervised by the trial principal investigator, and staff of the trial sponsor and their representatives directly involved in the execution of the trial and their respective families.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
2330 participants
