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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

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

June. 28, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Inclusion 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 >=35 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 or NP 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 consistently <30 mL/min/1.73 m2 for adults or CrCl <30 mL/min for adolescents, 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. History of hypersensitivity or other contraindication to any of the components of the study interventions.
9. 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.
10. Current use of any prohibited concomitant medication(s).
11. 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.
12. Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
13. 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).
14. Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
15. 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.

Both

COVID-19

*Drug: ibuzatrelvir
-ibuzatrelvir tablets
-Other Names:
#PF-07817883

*Drug: placebo
-placebo tablets

*Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality [Time Frame: 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.

*Time to all COVID-19 targeted symptoms resolution [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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. [Time Frame: Day 1 to Day 28]
*Number of days in hospital and ICU stay in participants with hospitalization (all-cause). [Time Frame: Day 1 to Week 24]
*Number of medical visits through Week 24. [Time Frame: 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. [Time Frame: Day 1 to Week 24]
*Time (days) to alleviation of all targeted symptoms through Day 28. [Time Frame: 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. [Time Frame: 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. [Time Frame: 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. [Time Frame: 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 [Time Frame: 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. [Time Frame: Day 1 to Day 34]

+81-3-6665-0572

Feb. 07, 2025

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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