Publications by authors named "Genki Ichihashi"
This exploratory analysis of the double-blind, phase 3, SCORPIO-SR trial assessed the effect of ensitrelvir in preventing post coronavirus disease 2019 (COVID-19) condition (PCC). Patients with mild-to-moderate COVID-19 were randomized (1:1:1) within 120 h of symptom onset; received 5-day oral ensitrelvir 125 mg (375 mg on day 1), 250 mg (750 mg on day 1), or a matching placebo once daily; and were assessed for the severity of typical PCC symptoms using a self-administered questionnaire. In total, 341, 317, and 333 patients were assessed in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively (mean age, 35.
View Article and Find Full Text PDFBackground: This phase 2b/3, randomized, placebo-controlled trial explored the efficacy and evaluated the safety of ensitrelvir. This trial involved individuals with asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and patients with mild symptoms of coronavirus disease 2019 (COVID-19).
Methods: The trial was conducted at 57 medical institutions in Japan, South Korea, and Vietnam (study period: January 6-August 14, 2022).
Importance: Treatment options for COVID-19 are warranted irrespective of the presence of risk factors for severe disease.
Objective: To assess the efficacy and safety of ensitrelvir in patients with mild to moderate COVID-19.
Design, Setting, And Participants: This phase 3 part of a phase 2/3, double-blind, placebo-controlled randomized clinical trial was conducted from February 10 to July 10, 2022, with a 28-day follow-up period, at 92 institutions in Japan, Vietnam, and South Korea.
Article Synopsis
- The phase 3 study aims to evaluate the efficacy and safety of ensitrelvir, a new oral treatment for mild-to-moderate COVID-19, regardless of vaccination status or risk factors.
- The study will involve patients within 120 hours of symptom onset, randomized into three groups receiving different doses of ensitrelvir or a placebo for 5 days.
- Primary outcomes include the time to resolution of five COVID-19 symptoms and changes in SARS-CoV-2 viral RNA levels, with additional safety assessments for adverse events.
Article Synopsis
- This study evaluated the effectiveness and safety of ensitrelvir in treating mild-to-moderate COVID-19 during the Omicron variant's spread.
- Patients were randomly assigned to receive different doses of ensitrelvir or a placebo over five days, with key measures being changes in virus levels and symptom scores.
- Results showed that ensitrelvir significantly reduced virus levels compared to placebo, and while overall symptom scores weren't different, ensitrelvir improved specific acute and respiratory symptoms, with mostly mild side effects reported.
Article Synopsis
- This study evaluated ensitrelvir, a new protease inhibitor for treating mild-to-moderate COVID-19, in Japanese patients.
- A total of 69 patients were assigned to receive either ensitrelvir in different doses or a placebo, with the primary focus on changes in SARS-CoV-2 viral levels over 28 days.
- Results indicated that ensitrelvir significantly reduced viral levels by -1.4 to -1.5 log copies/mL compared to placebo and decreased the time to viral clearance by about 50 hours, with mild side effects.