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

4. Luetkemeyer et al., Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial

2,085 patient ensitrelvir early treatment RCT: 203% higher hospitalization (p=0.37), 5% faster recovery (p=0.14), and 19% improved viral clearance (p=0.02).
RCT 2,093 outpatients with mild-to-moderate COVID-19 showing improved viral clearance but no significant difference in time to symptom resolution with ensitrelvir. Participants were randomized to receive ensitrelvir or placebo within five days of symptom onset, with the primary analysis focusing on those treated within three days. A mid-trial protocol change excluded participants treated more than three days post-symptom onset from the primary analysis.
Feb 2025, Clinical Infectious Diseases, https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf029/8017725, https://c19p.org/luetkemeyer

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