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All Studies   Meta Analysis    Recent:   

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., JAMA Network Open, doi:10.1001/jamanetworkopen.2023.54991 (date from preprint), SCORPIO-SR, jRCT2031210350
Jul 2023  
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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, 250mg 49% Change in viral load, 125mg 49% Change in viral load.. (b) 59% Change in viral load.. (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., JAMA Network Open, Jul 2023 Favorsensitrelvir Favorscontrol 0 0.5 1 1.5 2+
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, peer-reviewed, mean age 35.7, 13 authors, study period 10 February, 2022 - 10 July, 2022, trial jRCT2031210350 (SCORPIO-SR). Contact: takeki.uehara@shionogi.co.jp.
This PaperEnsitrelvirAll
Efficacy and Safety of 5-Day Oral Ensitrelvir for Patients With Mild to Moderate COVID-19
MD Hiroshi Yotsuyanagi, PhD Norio Ohmagari, PhD Yohei Doi, PhD Masaya Yamato, Nguyen Hoang Bac, Bong Ki Cha, PhD Takumi Imamura, MS Takuhiro Sonoyama, PhD Genki Ichihashi, PhD Takao Sanaki, MS Yuko Tsuge, PhD Takeki Uehara, MD Hiroshi Mukae
JAMA Network Open, doi:10.1001/jamanetworkopen.2023.54991
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, placebocontrolled 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. Patients (aged 12 to <70 years) with mild to moderate COVID-19 within 120 hours of positive viral test results were studied. INTERVENTIONS Patients were randomized (1:1:1) to receive 125 mg of once-daily ensitrelvir (375 mg on day 1), 250 mg of once-daily ensitrelvir (750 mg on day 1), or placebo for 5 days. MAIN OUTCOMES AND MEASURES The primary end point was the time to resolution of the composite of 5 characteristic symptoms of SARS-CoV-2 Omicron infection, assessed using a Peto-Prentice generalized Wilcoxon test stratified by vaccination history. Virologic efficacy and safety were also assessed. RESULTS A total of 1821 patients were randomized, of whom 1030 (347 in the 125-mg ensitrelvir group, 340 in the 250-mg ensitrelvir group, and 343 in the placebo group) were randomized in less than 72 hours of disease onset (primary analysis population). The mean (SD) age in this population was 35.2 (12.3) years, and 552 (53.6%) were men. A significant difference was observed between the 125-mg ensitrelvir group and the placebo group (P = .04 with a Peto-Prentice generalized Wilcoxon test). The difference in median time was approximately 1 day between the 125-mg ensitrelvir group and the placebo group (167.9 vs 192.2 hours; difference, -24.3 hours; 95% CI, -78.7 to 11.7 hours). Adverse events were observed in 267 of 604 patients (44.2%) in the 125-mg ensitrelvir group, 321 of 599 patients (53.6%) in the 250-mg ensitrelvir group, and 150 of 605 patients (24.8%) in the placebo group, which included a decrease in high-density lipoprotein level (188 [31.1%] in the 125-mg ensitrelvir group, 231 [38.6%] in the 250-mg ensitrelvir group, and 23 [3.8%] in the placebo group). No treatment-related serious adverse events were reported. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, 125-mg ensitrelvir treatment reduced the time to resolution of the 5 typical COVID-19 symptoms compared with placebo in patients treated in less than 72 hours of disease onset; the absolute difference in median time to (continued) Key Points Question Can ensitrelvir, an oral SARS-CoV-2 3C-like protease inhibitor, shorten the duration of symptoms in patients with mild to moderate COVID-19 irrespective of the presence of risk factors for severe disease? Findings In this randomized clinical trial of 1821 patients with mild to moderate COVID-19, among 1030 patients randomized in less than 72 hours of disease onset, a statistically significant difference was observed in the time to resolution..
Limitations The major limitation of this study is that it was conducted only in Asian countries, with a limited number of non-Asian patients. Also, ensitrelvir shortened the symptom duration, but the difference in median time was approximately 1 day compared with placebo. The efficacy and safety of ensitrelvir in various patient populations should be further assessed in daily clinical settings.
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' 'Patients (aged 12 to &amp;amp;lt;70 years) with mild to moderate COVID-19 within 120 hours of ' 'positive viral test results were ' 'studied.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Patients ' 'were randomized (1:1:1) to receive 125 mg of once-daily ensitrelvir (375 mg on day 1), 250 mg ' 'of once-daily ensitrelvir (750 mg on day 1), or placebo for 5 ' 'days.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and ' 'Measures</jats:title><jats:p>The primary end point was the time to resolution of the ' 'composite of 5 characteristic symptoms of SARS-CoV-2 Omicron infection, assessed using a ' 'Peto-Prentice generalized Wilcoxon test stratified by vaccination history. Virologic efficacy ' 'and safety were also ' 'assessed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of ' '1821 patients were randomized, of whom 1030 (347 in the 125-mg ensitrelvir group, 340 in the ' '250-mg ensitrelvir group, and 343 in the placebo group) were randomized in less than 72 hours ' 'of disease onset (primary analysis population). The mean (SD) age in this population was 35.2 ' '(12.3) years, and 552 (53.6%) were men. A significant difference was observed between the ' '125-mg ensitrelvir group and the placebo group (<jats:italic>P</jats:italic>\u2009=\u2009.04 ' 'with a Peto-Prentice generalized Wilcoxon test). The difference in median time was ' 'approximately 1 day between the 125-mg ensitrelvir group and the placebo group (167.9 vs ' '192.2 hours; difference, −24.3 hours; 95% CI, −78.7 to 11.7 hours). Adverse events were ' 'observed in 267 of 604 patients (44.2%) in the 125-mg ensitrelvir group, 321 of 599 patients ' '(53.6%) in the 250-mg ensitrelvir group, and 150 of 605 patients (24.8%) in the placebo ' 'group, which included a decrease in high-density lipoprotein level (188 [31.1%] in the 125-mg ' 'ensitrelvir group, 231 [38.6%] in the 250-mg ensitrelvir group, and 23 [3.8%] in the placebo ' 'group). No treatment-related serious adverse events were ' 'reported.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and ' 'Relevance</jats:title><jats:p>In this randomized clinical trial, 125-mg ensitrelvir treatment ' 'reduced the time to resolution of the 5 typical COVID-19 symptoms compared with placebo in ' 'patients treated in less than 72 hours of disease onset; the absolute difference in median ' 'time to resolution was approximately 1 day. Ensitrelvir demonstrated clinical and antiviral ' 'efficacy without new safety concerns. 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'key': 'zoi231613r16', 'doi-asserted-by': 'publisher', 'DOI': '10.1126/scitranslmed.abq4064', 'article-title': 'S-217622, a SARS-CoV-2 main protease inhibitor, decreases viral load ' 'and ameliorates COVID-19 severity in hamsters.', 'volume': '15', 'author': 'Sasaki', 'year': '2023', 'journal-title': 'Sci Transl Med'}, { 'key': 'zoi231613r17', 'doi-asserted-by': 'publisher', 'first-page': '132', 'DOI': '10.1016/j.bbrc.2023.01.040', 'article-title': 'Ensitrelvir is effective against SARS-CoV-2 3CL protease mutants ' 'circulating globally.', 'volume': '645', 'author': 'Kawashima', 'year': '2023', 'journal-title': 'Biochem Biophys Res Commun'}, { 'issue': '4', 'key': 'zoi231613r18', 'doi-asserted-by': 'publisher', 'first-page': '402', 'DOI': '10.1016/S1473-3099(23)00070-1', 'article-title': 'Antiviral and bivalent vaccine efficacy against an omicron XBB.1.5 ' 'isolate.', 'volume': '23', 'author': 'Uraki', 'year': '2023', 'journal-title': 'Lancet Infect Dis'}, { 'issue': '10', 'key': 'zoi231613r19', 'doi-asserted-by': 'publisher', 'DOI': '10.1128/aac.00697-22', 'article-title': '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.', 'volume': '66', 'author': 'Mukae', 'year': '2022', 'journal-title': 'Antimicrob Agents Chemother'}, { 'issue': '8', 'key': 'zoi231613r20', 'doi-asserted-by': 'publisher', 'first-page': '1403', 'DOI': '10.1093/cid/ciac933', 'article-title': '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.', 'volume': '76', 'author': 'Mukae', 'year': '2023', 'journal-title': 'Clin Infect Dis'}, { 'issue': '20', 'key': 'zoi231613r21', 'doi-asserted-by': 'publisher', 'first-page': '2191', 'DOI': '10.1001/jama.2013.281053', 'article-title': 'World Medical Association Declaration of Helsinki: ethical principles ' 'for medical research involving human subjects.', 'volume': '310', 'author': 'World Medical Association', 'year': '2013', 'journal-title': 'JAMA'}, { 'issue': '8', 'key': 'zoi231613r22', 'doi-asserted-by': 'publisher', 'DOI': '10.1097/MD.0000000000033024', 'article-title': 'A phase 2/3 study of S-217622 in participants with SARS-CoV-2 infection ' '(Phase 3 part).', 'volume': '102', 'author': 'Yotsuyanagi', 'year': '2023', 'journal-title': 'Medicine (Baltimore)'}, { 'issue': '35', 'key': 'zoi231613r25', 'doi-asserted-by': 'publisher', 'first-page': '3455', 'DOI': '10.1200/JCO.19.01681', 'article-title': 'Methods for accommodating nonproportional hazards in clinical trials: ' 'ready for the primary analysis?', 'volume': '37', 'author': 'Freidlin', 'year': '2019', 'journal-title': 'J Clin Oncol'}, { 'issue': '10', 'key': 'zoi231613r26', 'doi-asserted-by': 'publisher', 'DOI': '10.1128/aac.00632-22', 'article-title': 'Safety, tolerability, and pharmacokinetics of the novel antiviral agent ' 'ensitrelvir fumaric acid, a SARS-CoV-2 3CL protease inhibitor, in ' 'healthy adults.', 'volume': '66', 'author': 'Shimizu', 'year': '2022', 'journal-title': 'Antimicrob Agents Chemother'}, { 'key': 'zoi231613r27', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.lanepe.2022.100556', 'article-title': 'Severity of Omicron (B.1.1.529) and Delta (B.1.617.2) SARS-CoV-2 ' 'infection among hospitalised adults: a prospective cohort study in ' 'Bristol, United Kingdom.', 'volume': '25', 'author': 'Hyams', 'year': '2023', 'journal-title': 'Lancet Reg Health Eur'}, { 'issue': '10373', 'key': 'zoi231613r28', 'doi-asserted-by': 'publisher', 'first-page': '281', 'DOI': '10.1016/S0140-6736(22)02597-1', 'article-title': 'Molnupiravir plus usual care versus usual care alone as early treatment ' 'for adults with COVID-19 at increased risk of adverse outcomes ' '(PANORAMIC): an open-label, platform-adaptive randomised controlled ' 'trial.', 'volume': '401', 'author': 'Butler', 'year': '2023', 'journal-title': 'Lancet'}, { 'issue': '3', 'key': 'zoi231613r29', 'doi-asserted-by': 'publisher', 'first-page': '453', 'DOI': '10.1093/cid/ciac781', 'article-title': 'Effectiveness of molnupiravir in high-risk patients: a propensity score ' 'matched analysis.', 'volume': '76', 'author': 'Najjar-Debbiny', 'year': '2023', 'journal-title': 'Clin Infect Dis'}, { 'key': 'zoi231613r31', 'doi-asserted-by': 'publisher', 'author': 'Hammond', 'year': '2022', 'DOI': '10.1093/ofid/ofac492.994'}, { 'key': 'zoi231613r1', 'unstructured': 'World Health Organization. Classification of Omicron (B.1.1.529): ' 'SARS-CoV-2 variant of concern. Accessed October 2, 2023. ' 'https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.1.529)-sars-cov-2-variant-of-concern'}, { 'key': 'zoi231613r7', 'unstructured': 'World Health Organization. TAG-VE statement on Omicron sublineages BQ.1 ' 'and XBB. Accessed October 2, 2023. ' 'https://www.who.int/news/item/27-10-2022-tag-ve-statement-on-omicron-sublineages-bq.1-and-xbb'}, { 'key': 'zoi231613r23', 'unstructured': 'US Food and Drug Administration. Assessing COVID-19-related symptoms in ' 'outpatient adult and adolescent subjects in clinical trials of drugs and ' 'biological products for COVID-19 prevention or treatment. Accessed ' 'October 2, 2023. ' 'https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-covid-19-related-symptoms-outpatient-adult-and-adolescent-subjects-clinical-trials-drugs'}, { 'key': 'zoi231613r24', 'unstructured': 'Hiroshima Prefectural Health and Welfare Bureau. Findings from the ' 'analysis of J-SPEED (Surveillance in Post Extreme Emergencies and ' 'Disasters, Japan version) data: wave 7 analysis. Accessed October 2, ' '2023. https://www.mhlw.go.jp/content/10900000/000975398.pdf'}, { 'key': 'zoi231613r30', 'unstructured': 'ClinicalTrials.gov. Evaluation of Protease Inhibition for COVID-19 in ' 'Standard-Risk Patients (EPIC-SR). NCT05011513. Accessed October 2, 2023. ' 'https://clinicaltrials.gov/study/NCT05011513'}, { 'key': 'zoi231613r32', 'unstructured': 'US Food and Drug Administration. Meeting of the Antimicrobial Drugs ' 'Advisory Committee March 16, 2023: FDA Briefing Document. Accessed ' 'October 2, 2023. https://www.fda.gov/media/166197/download'}, { 'key': 'zoi231613r33', 'unstructured': 'ClinicalTrials.gov. A Study to Compare S-217622 With Placebo in ' 'Non-Hospitalized Participants With COVID-19 (SCORPIO-HR). NCT05305547. ' 'Accessed October 2, 2023. ' 'https://classic.clinicaltrials.gov/ct2/show/NCT05305547'}, { 'key': 'zoi231613r34', 'unstructured': 'ClinicalTrials.gov. Strategies and Treatments for Respiratory Infections ' '&; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor. NCT05605093. ' 'Accessed October 2, 2023. https://clinicaltrials.gov/study/NCT05605093'}, { 'key': 'zoi231613r35', 'unstructured': 'ClinicalTrials.gov. A Phase 3 Study of S-217622 in Pediatric ' 'Participants Aged 6 to &lt;12 With SARS-CoV-2 Infection. jRCT2031230140. ' 'Accessed October 2, 2023. ' 'https://jrct.niph.go.jp/en-latest-detail/jRCT2031230140'}], 'container-title': 'JAMA Network Open', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2814871/yotsuyanagi_2024_oi_231613_1706809715.91975.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 2, 9]], 'date-time': '2024-02-09T16:32:02Z', 'timestamp': 1707496322000}, 'score': 1, 'resource': {'primary': {'URL': 'https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2814871'}}, 'subtitle': ['The SCORPIO-SR Randomized Clinical Trial'], 'short-title': [], 'issued': {'date-parts': [[2024, 2, 9]]}, 'references-count': 35, 'journal-issue': {'issue': '2', 'published-print': {'date-parts': [[2024, 2, 5]]}}, 'URL': 'http://dx.doi.org/10.1001/jamanetworkopen.2023.54991', 'relation': {}, 'ISSN': ['2574-3805'], 'subject': ['General Medicine'], 'container-title-short': 'JAMA Netw Open', 'published': {'date-parts': [[2024, 2, 9]]}}
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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