Summary of COVID-19 ibuzatrelvir studies

1. Mortezavi et al., Virologic Response and Safety of Ibuzatrelvir, a Novel SARS-CoV-2 Antiviral, in Adults With COVID-19

133 patient ibuzatrelvir early treatment RCT: 27% improved viral clearance (p=0.0001).
RCT 240 outpatients showing significant viral load reduction with ibuzatrelvir (an oral SARS-CoV-2 Mpro inhibitor) compared to placebo. The study enrolled non-hospitalized adults aged 18-65 with symptomatic COVID-19 (≤5 days) and positive rapid antigen test, excluding those with obesity, smoking, chronic conditions, or immunocompromised status. Patients were randomized 1:1:2:2 to receive 100mg, 300mg, or 600mg ibuzatrelvir or placebo twice daily for 5 days. There were dose-dependent decreases in viral load at days 3 and 5 compared to placebo. The trial has limited generalizability due to strict exclusion criteria that eliminated many high-risk patients who would typically be candidates for antiviral therapy.
Nov 2024, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciae529/7863440, https://c19p.org/mortezavi