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All Studies   Meta Analysis    Recent:   

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

Mukae et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac933, jRCT2031210350
Dec 2022  
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Improvement in symptom.. 9% Improvement Relative Risk Improvement in sym.. (b) 17% Time to viral-, 250mg 32% Time to viral-, 125mg 44% Ensitrelvir  Mukae et al.  EARLY TREATMENT  DB RCT Is early treatment with ensitrelvir beneficial for COVID-19? Double-blind RCT 227 patients in Japan (January - February 2022) Faster viral clearance with ensitrelvir (p=0.0001) c19early.org Mukae et al., Clinical Infectious Dise.., Dec 2022 Favorsensitrelvir Favorscontrol 0 0.5 1 1.5 2+
RCT 428 COVID-19 patients in Japan showing faster viral clearance and improved recovery with ensitrelvir.
relative improvement in symptom score, 9.2% better, RR 0.91, p = 0.28, treatment mean 5.42 (±3.7) n=116, control mean 4.92 (±3.25) n=111, 250mg, Table 2.
relative improvement in symptom score, 17.3% better, RR 0.83, p = 0.04, treatment mean 5.95 (±4.02) n=114, control mean 4.92 (±3.25) n=111, 125mg, Table 2.
time to viral-, 32.4% lower, relative time 0.68, p < 0.001, treatment 113, control 108, relative time to first negative viral titer, 250mg, Figure 3.
time to viral-, 44.2% lower, relative time 0.56, p < 0.001, treatment 113, control 108, relative time to first negative viral titer, 125mg, Figure 3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Mukae et al., 7 Dec 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Japan, peer-reviewed, 11 authors, study period 2 January, 2022 - 9 February, 2022, trial jRCT2031210350. Contact: takeki.uehara@shionogi.co.jp.
This PaperEnsitrelvirAll
Efficacy and Safety of Ensitrelvir in Patients With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19): The Phase 2b Part of a Randomized, Placebo-Controlled, Phase 2/3 Study
Hiroshi Mukae, Hiroshi Yotsuyanagi, Norio Ohmagari, Yohei Doi, Hiroki Sakaguchi, Takuhiro Sonoyama, Genki Ichihashi, Takao Sanaki, Keiko Baba, Yuko Tsuge, Takeki Uehara
Clinical Infectious Diseases, doi:10.1093/cid/ciac933
Background. This phase 2b part of a randomized phase 2/3 study assessed the efficacy and safety of ensitrelvir for mild-to-moderate coronavirus disease 2019 (COVID-19) during the Omicron epidemic.
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The co-primary endpoints were the change from baseline in the severe acute respiratory ' 'syndrome coronavirus 2 (SARS-CoV-2) titer on day 4 and time-weighted average change from ' 'baseline up to 120\u2005hours in the total score of predefined 12 COVID-19 symptoms. Safety ' 'was assessed through adverse events.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>A total of 341 patients (ensitrelvir 125 mg group, 114; ensitrelvir ' '250 mg group, 116; and placebo group, 111; male, 53.5%–64.9%; mean age, 35.3–37.3 years) were ' 'included in the efficacy analyses. The change from baseline in the SARS-CoV-2 titer on day 4 ' 'was significantly greater with both ensitrelvir doses than with placebo (differences from ' 'placebo: -0.41 log10 50% tissue-culture infectious dose/mL, P\u2009&amp;lt;\u20090.0001 for ' 'both). The total score of the 12 COVID-19 symptoms did not show a significant difference ' 'between the ensitrelvir groups and placebo group. The time-weighted average change from ' 'baseline up to 120\u2005hours was significantly greater with ensitrelvir versus placebo in ' 'several subtotal scores, including acute symptoms and respiratory symptoms. Most adverse ' 'events were mild in severity.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Ensitrelvir treatment demonstrated a favorable antiviral efficacy ' 'and potential clinical benefit with an acceptable safety profile.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1093/cid/ciac933', 'type': 'journal-article', 'created': {'date-parts': [[2022, 12, 7]], 'date-time': '2022-12-07T07:28:23Z', 'timestamp': 1670398103000}, 'source': 'Crossref', 'is-referenced-by-count': 0, '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', 'prefix': '10.1093', 'author': [ { 'given': 'Hiroshi', 'family': 'Mukae', 'sequence': 'first', 'affiliation': [ { 'name': 'Department of Respiratory Medicine, Nagasaki University Graduate ' 'School of Biomedical Sciences , Nagasaki , Japan'}]}, { 'given': 'Hiroshi', 'family': 'Yotsuyanagi', 'sequence': 'additional', 'affiliation': [ { 'name': 'The Institute of Medical Science, The University of Tokyo , ' 'Tokyo , Japan'}]}, { 'ORCID': 'http://orcid.org/0000-0002-4622-8970', 'authenticated-orcid': False, 'given': 'Norio', 'family': 'Ohmagari', 'sequence': 'additional', 'affiliation': [ { 'name': 'Disease Control and Prevention Center, National Center for ' 'Global Health and Medicine , Tokyo , Japan'}]}, { 'given': 'Yohei', 'family': 'Doi', 'sequence': 'additional', 'affiliation': [ { 'name': 'Division of Infectious Diseases, University of Pittsburgh School ' 'of Medicine , Pittsburgh, Pennsylvania , USA'}, { 'name': 'Departments of Microbiology and Infectious Diseases, Fujita ' 'Health University School of Medicine , Toyoake , Japan'}]}, { 'given': 'Hiroki', 'family': 'Sakaguchi', 'sequence': 'additional', 'affiliation': [ { 'name': 'Drug Development and Regulatory Science Division, Shionogi & ' 'Co., Ltd. , Osaka , Japan'}]}, { 'given': 'Takuhiro', 'family': 'Sonoyama', 'sequence': 'additional', 'affiliation': [ { 'name': 'Drug Development and Regulatory Science Division, Shionogi & ' 'Co., Ltd. , Osaka , Japan'}]}, { 'given': 'Genki', 'family': 'Ichihashi', 'sequence': 'additional', 'affiliation': [ { 'name': 'Drug Development and Regulatory Science Division, Shionogi & ' 'Co., Ltd. , Osaka , Japan'}]}, { 'ORCID': 'http://orcid.org/0000-0001-8847-0071', 'authenticated-orcid': False, 'given': 'Takao', 'family': 'Sanaki', 'sequence': 'additional', 'affiliation': [ { 'name': 'Pharmaceutical Research Division, Shionogi & Co., Ltd. , ' 'Toyonaka , Japan'}]}, { 'given': 'Keiko', 'family': 'Baba', 'sequence': 'additional', 'affiliation': [ { 'name': 'Pharmaceutical Research Division, Shionogi & Co., Ltd. , ' 'Toyonaka , Japan'}]}, { 'given': 'Yuko', 'family': 'Tsuge', 'sequence': 'additional', 'affiliation': [ { 'name': 'Drug Development and Regulatory Science Division, Shionogi & ' 'Co., Ltd. , Osaka , Japan'}]}, { 'given': 'Takeki', 'family': 'Uehara', 'sequence': 'additional', 'affiliation': [ { 'name': 'Drug Development and Regulatory Science Division, Shionogi & ' 'Co., Ltd. , Osaka , Japan'}]}], 'member': '286', 'published-online': {'date-parts': [[2022, 12, 7]]}, 'container-title': 'Clinical Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciac933/47684795/ciac933.pdf', 'content-type': 'application/pdf', 'content-version': 'am', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciac933/47684795/ciac933.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 12, 7]], 'date-time': '2022-12-07T16:31:04Z', 'timestamp': 1670430664000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac933/6881001'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 12, 7]]}, 'references-count': 0, 'URL': 'http://dx.doi.org/10.1093/cid/ciac933', 'relation': {}, 'ISSN': ['1058-4838', '1537-6591'], 'subject': ['Infectious Diseases', 'Microbiology (medical)'], 'published': {'date-parts': [[2022, 12, 7]]}}
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