jRCT2031240698Not yet recruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Pfizer Japan Inc.
- Enrollment
- 2,330
- Primary Endpoint
- Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 12age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •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 >=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
- •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
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time to all COVID-19 targeted symptoms resolution(Day 1 to Day 28)
- Proportion of participants with post acute COVID-19 medical events(Day 29 to Week 24)
- Proportion of participants with cardiovascular, renal and pulmonary events(Day 1 to Week 24)
- Proportion of participants with Long COVID symptoms(Day 29 to Week 24)
- Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal swabs(Day 1 through Day 34)
- Time to SARS-CoV-2 RNA <LLOQ(Day 1 through Day 34)
- Proportion of participants with SARS-CoV-2 RNA <LLOQ at each visit(Day 1 through Day 34)
- Proportion of participants with rebound in SARS-CoV-2 RNA levels in nasopharyngeal swab(Day 10 and Day 14)
- Proportion of participants with virologic and symptomatic rebound through Day 28(Day 10 to Day 34)
- Number of medical visits through Week 24.(Day 1 to Week 24)
- Time (days) to alleviation of all targeted symptoms through Day 28.(Day 1 to Day 28)
- Proportion of participants with severe symptoms attributed to COVID-19 through Day 28.(Day 1 to Day 28)
- Duration of each targeted COVID-19 sign/symptom.(Day 1 to Day 28)
- Proportion of participants with symptomatic rebound through Day 28.(Day 1 to Day 28)
- Incidence of treatment emergent adverse events(Day 1 to Day 34)
Investigators
Similar Trials
Not yet recruiting
Not Applicable
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual MigraineMenstrual MigrainejRCT2031250041Pfizer Japan Inc.723
Recruiting
Not Applicable
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe AsthmaAsthmajRCT2031250163Pfizer Japan Inc.252
Recruiting
Not Applicable
A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease (EPIC-Peds)jRCT2031250096Pfizer Japan Inc.160
Not yet recruiting
Not Applicable
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF) (BRANCH-HF)jRCT2031250168Pfizer Japan Inc.620
Active, not recruiting
Phase 1
A Study to Learn About the Study Medicine Called PF-07293893 in Healthy Adults, and How Different Doses of Study Medicine are Tolerated and Act in the Body.CTIS2023-504921-37-00Pfizer Inc.24