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.
12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
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;
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.
Parallel
ibuzatrelvir
Drugibuzatrelvir tablets
placebo
Drugplacebo tablets
Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality
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 sustained resolution of all COVID-19 targeted symptoms
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
Medical events include cardiovascular events, pulmonary events, acute kidney disease and thromboembolic events.
Proportion of participants with cardiovascular, renal and pulmonary events
Medical events include cardiovascular events, pulmonary events, acute kidney disease and thromboembolic events.
Proportion of participants with Long COVID symptoms
The difference in proportions of patients with Long COVID symptoms at Week 24. Symptoms will be assessed through a weekly electronic diary.
