Summary of COVID-19 ensitrelvir studies

1. Mukae et al., A Randomized Phase 2/3 Study of Ensitrelvir, a Novel Oral SARS-CoV-2 3C-like Protease Inhibitor, in Japanese Patients With Mild-to-Moderate COVID-19 or Asymptomatic SARS-CoV-2 Infection: Results of the Phase 2a Part

69 patient ensitrelvir early treatment RCT: 45% improved viral clearance (p=0.002).
RCT 69 patients in in Japan, showing faster viral clearance with ensitrelvir. 5-day ensitrelvir (375mg on day 1 followed by 125 mg daily or 750mg on day 1 followed by 250mg daily).
May 2022, medRxiv, https://www.medrxiv.org/content/early/2022/05/17/2022.05.17.22275027, https://c19p.org/mukae

2. Mukae et al., Efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19: the phase 2b part of a randomized, placebo-controlled, phase 2/3 study

227 patient ensitrelvir early treatment RCT: 9% improved recovery (p=0.28) and 32% faster viral clearance (p=0.0001).
RCT 428 COVID-19 patients in Japan showing faster viral clearance and improved recovery with ensitrelvir.
Dec 2022, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac933/6881001, https://c19p.org/mukae3

3. Yotsuyanagi et al., Efficacy and Safety of 5-Day Oral Ensitrelvir for Patients With Mild to Moderate COVID-19: The SCORPIO-SR Randomized Clinical Trial

1,821 patient ensitrelvir early treatment RCT: 11% faster recovery (p=0.3) and 49% improved viral clearance (p=0.001).
RCT 1,821 COVID-19 outpatients in Japan, Vietnam, and South Korea, showing improved viral clearance and improved recovery (significant for patients treated within 3 days of onset) with ensitrelvir. Only 2 hospitalizations were reported, with no deaths.
Jul 2023, JAMA Network Open, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2814871, https://c19p.org/yotsuyanagi

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