Recruiting NCT06679140

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

Phase III Interventional COVID-19 SARS-CoV-2 Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: ibuzatrelvir, placebo.
Who it may be relevant to: Registry conditions: COVID-19 SARS-CoV-2 Infection. Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Belgium, Brazil, Bulgaria +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Interventions

Drug ibuzatrelvir
ibuzatrelvir tablets
Drug placebo
placebo tablets

Primary outcome measures

Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality [Time frame: Day 1 through Day 28]

Secondary outcome measures (12)

Time to sustained resolution of all COVID-19 targeted symptoms [Time frame: Day 1 to Day 28]
Proportion of participants with post acute COVID-19 medical events [Time frame: Day 29 to Week 24]
Proportion of participants with cardiovascular, renal and pulmonary events [Time frame: Day 1 to Week 24]
Proportion of participants with Long COVID symptoms [Time frame: Day 29 to Week 24]
Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal/nasal swabs [Time frame: Day 1 through Day 34]
Time to SARS-CoV-2 RNA <LLOQ [Time frame: Day 1 through Day 34]
Proportion of participants with SARS-CoV-2 RNA <LLOQ at each visit [Time frame: Day 1 through Day 34]
Proportion of participants with rebound in SARS-CoV-2 RNA levels in nasopharyngeal swab [Time frame: Day 10 and Day 14]
Proportion of participants with virologic and symptomatic rebound through Day 28 [Time frame: Day 10 to Day 34]
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]

Eligibility criteria

Inclusion criteria

12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:

12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
50 to 64 years of age with at least two risk factors;
65 to 74 years of age with at least one risk factor;
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.

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.
Participants must be unable or unwilling to take nirmatrelvir/ritonavir.

Exclusion criteria

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.
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.
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.
Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
Severely immunocompromised.
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.
History of hypersensitivity or other contraindication to any of the components of the study interventions.
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).

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment