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All Studies   All Outcomes   Recent:  
0 0.5 1 1.5 2+ Hospitalization, 250mg -1% Improvement Relative Risk Hospitalization, 125mg 67% Recovery time, 250mg 11% Recovery time, 125mg 10% Recovery time, 250mg (b) 18% Recovery time, 125mg (b) 19% Recovery time, 250mg (c) 13% Recovery time, 125mg (c) 10% Recovery time, 250mg (d) 13% Recovery time, 125mg (d) 16% Change in viral load, 2.. 49% Change in viral load, 1.. 49% Change in viral loa.. (b) 59% Change in viral loa.. (b) 59% Ensitrelvir  SCORPIO-SR  EARLY TREATMENT  DB RCT Is early treatment with ensitrelvir beneficial for COVID-19? Double-blind RCT 1,821 patients in multiple countries (Feb - Jul 2022) Improved viral clearance with ensitrelvir (p=0.001) c19early.org Yotsuyanagi et al., medRxiv, July 2023 Favors ensitrelvir Favors control

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

Yotsuyanagi et al., medRxiv, doi:10.1101/2023.07.11.23292264, SCORPIO-SR, jRCT2031210350
Jul 2023  
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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.
risk of hospitalization, 0.8% higher, RR 1.01, p = 1.00, treatment 1 of 595 (0.2%), control 1 of 600 (0.2%), 250mg.
risk of hospitalization, 66.7% lower, RR 0.33, p = 0.50, treatment 0 of 603 (0.0%), control 1 of 600 (0.2%), NNT 600, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 125mg.
recovery time, 11.4% lower, relative time 0.89, p = 0.30, treatment 577, control 572, 14 symptoms, randomized within 120 hours, 250mg.
recovery time, 10.1% lower, relative time 0.90, p = 0.46, treatment 582, control 572, 14 symptoms, randomized within 120 hours, 125mg.
recovery time, 17.9% lower, relative time 0.82, p = 0.05, treatment 330, control 321, 14 symptoms, randomized within 72 hours, 250mg.
recovery time, 19.0% lower, relative time 0.81, p = 0.03, treatment 336, control 321, 14 symptoms, randomized within 72 hours, 125mg.
recovery time, 13.3% lower, relative time 0.87, p = 0.35, treatment 577, control 572, 12 symptoms, randomized within 120 hours, 250mg.
recovery time, 9.7% lower, relative time 0.90, p = 0.76, treatment 582, control 572, 12 symptoms, randomized within 120 hours, 125mg.
recovery time, 13.3% lower, relative time 0.87, p = 0.08, treatment 330, control 321, 12 symptoms, randomized within 72 hours, 250mg.
recovery time, 15.9% lower, relative time 0.84, p = 0.07, treatment 336, control 321, 12 symptoms, randomized within 72 hours, 125mg.
relative change in viral load, 48.8% better, RR 0.51, p < 0.001, treatment 579, control 589, randomized within 120 hours, 250mg.
relative change in viral load, 48.8% better, RR 0.51, p < 0.001, treatment 592, control 589, randomized within 120 hours, 125mg.
relative change in viral load, 59.4% better, RR 0.41, p < 0.001, treatment 330, control 321, randomized within 72 hours, 250mg.
relative change in viral load, 59.3% better, RR 0.41, p < 0.001, treatment 336, control 321, randomized within 72 hours, 125mg.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Yotsuyanagi et al., 13 Jul 2023, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, preprint, mean age 35.7, 13 authors, study period 10 February, 2022 - 10 July, 2022, trial jRCT2031210350 (SCORPIO-SR).
Contact: takeki.uehara@shionogi.co.jp.
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This PaperEnsitrelvirAll
Efficacy and Safety of 5-Day Oral Ensitrelvir for Patients With Mild-to-Moderate COVID-19: The SCORPIO-SR Randomized Clinical Trial
M.D Hiroshi Yotsuyanagi, M.D Norio Ohmagari, M.D Yohei Doi, M.D Masaya Yamato, M.D Nguyen Hoang Bac, M.D Bong Ki Cha, M.S Takumi Imamura, M.D Takuhiro Sonoyama, Genki Ichihashi, Ph.D Takao Sanaki, M.S Yuko Tsuge, Ph.D Takeki Uehara, M.D Hiroshi Mukae
doi:10.1101/2023.07.11.23292264
IMPORTANCE Treatment options for coronavirus disease 2019 (COVID-19) that can be used irrespective of risk factors for severe disease are warranted. OBJECTIVE To assess the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19. DESIGN The phase 3 part of a phase 2/3, double-blind, randomized, placebo-controlled study conducted from February 10 to July 10, 2022. SETTING A multicenter study conducted at 92 institutions in Japan, Vietnam, and South Korea. PARTICIPANTS Patients (aged 12 to <70 years) with mild-to-moderate COVID-19 within 120 hours of positive viral testing. INTERVENTIONS Patients were randomized (1:1:1) to receive once-daily ensitrelvir 125 mg (375 mg on day 1), 250 mg (750 mg on day 1), or placebo for 5 days. Among 1821 randomized patients, 1030 (347, 340, and 343 in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively) were randomized in less than 72 hours of disease onset and assessed as the primary analysis population. MAIN OUTCOMES AND MEASURES The primary end point was the time to resolution of five COVID-19 symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness). Other end points included virologic efficacy and safety. RESULTS The mean age was 35.7, 35.3, and 34.7 years, and 193 (55.6%), 185 (54.4%), and 174 (50.7%) patients were men in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively (intention-to-treat, primary analysis population). A significant difference (P=.04 with a Peto-Prentice generalized Wilcoxon test stratified by vaccination history) was observed in the primary end point between ensitrelvir 125 mg and placebo in the primary
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