{"created":"2023-05-15T16:50:01.575431+00:00","id":27721,"links":{},"metadata":{"_buckets":{"deposit":"3e38523b-a24e-4301-8c8d-0cce6da8c4a5"},"_deposit":{"created_by":6,"id":"27721","owners":[6],"pid":{"revision_id":0,"type":"depid","value":"27721"},"status":"published"},"_oai":{"id":"oai:nagasaki-u.repo.nii.ac.jp:00027721","sets":["10:11"]},"author_link":["123321","123326","123323","123329","123330","123319","123327","123318","123325","123324","123322","123320","123328"],"item_2_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2022-09-13","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"10","bibliographicPageStart":"e0069722","bibliographicVolumeNumber":"66","bibliographic_titles":[{"bibliographic_title":"Antimicrobial Agents and Chemotherapy"}]}]},"item_2_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"This multicenter, double-blind, phase 2a part of a phase 2/3 study assessed the efficacy and safety of ensitrelvir, a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like protease inhibitor, in Japanese patients with mild-to-moderate coronavirus disease 2019 (COVID-19) or asymptomatic ARSCoV- 2 infection. Sixty-nine patients were randomized (1:1:1) to orally receive 5-day ensitrelvir fumaric acid (375 mg on day 1 followed by 125 mg daily, or 750 mg on day 1 followed by 250 mg daily) or placebo and followed up until day 28. The primary outcome was the change from baseline in the SARS-CoV-2 viral titer. A total of 16, 14, and 17 patients in the ensitrelvir 125 mg, ensitrelvir 250 mg, and placebo groups, respectively, were included in the intention-to-treat population (mean age: 38.0 to 40.4 years). On day 4, the change from baseline in SARS-CoV-2 viral titer (log10 50% tissue culture infectious dose/mL) in patients with positive viral titer and viral RNA at baseline was greater with ensitrelvir 125 mg (mean [standard deviation], –2.42 [1.42]; P = 0.0712) and 250 mg (–2.81 [1.21]; P = 0.0083) versus placebo (–1.54 [0.74]); ensitrelvir treatment reduced SARS-CoV-2 RNA by –1.4 to –1.5 log10 copies/ mL versus placebo. The viral titer and viral RNA were similar across groups on and after day 6. The median time to infectious viral clearance decreased by approximately 50 h with ensitrelvir treatment. All adverse events were mild to moderate. Ensitrelvir treatment demonstrated rapid SARS-CoV-2 clearance and was well tolerated (Japan Registry of Clinical Trials identifier: jRCT2031210350).","subitem_description_type":"Abstract"}]},"item_2_description_63":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"Antimicrobial Agents and Chemotherapy, 66(10), art. no. e0069722; 2022 　","subitem_description_type":"Other"}]},"item_2_publisher_33":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"American Society for Microbiology"}]},"item_2_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1128/aac.00697-22","subitem_relation_type_select":"DOI"}}]},"item_2_rights_13":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"ⓒ 2022 Mukae et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license."}]},"item_2_source_id_7":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0066-4804","subitem_source_identifier_type":"ISSN"}]},"item_2_version_type_16":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Mukae, Hiroshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yotsuyanagi, Hiroshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Ohmagari, Norio"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Doi, Yohei"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Imamura, Takumi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Sonoyama, Takuhiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Fukuhara, Takahiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Ichihashi, Genki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Sanaki, Takao"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Baba, Keiko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Takeda, Yosuke"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Tsuge, Yuko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Uehara, Takeki"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2022-10-31"}],"displaytype":"detail","filename":"AAC66_e0069722.pdf","filesize":[{"value":"1.6 MB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"AAC66_e0069722.pdf","url":"https://nagasaki-u.repo.nii.ac.jp/record/27721/files/AAC66_e0069722.pdf"},"version_id":"8254ae45-aac0-4778-90b7-a02717184a30"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"COVID-19","subitem_subject_scheme":"Other"},{"subitem_subject":"ensitrelvir","subitem_subject_scheme":"Other"},{"subitem_subject":"Japanese","subitem_subject_scheme":"Other"},{"subitem_subject":"proof-of-concept study","subitem_subject_scheme":"Other"},{"subitem_subject":"S-217622","subitem_subject_scheme":"Other"},{"subitem_subject":"SARSCoV- 2 3C-like protease inhibitor","subitem_subject_scheme":"Other"},{"subitem_subject":"viral titer","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_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","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_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"}]},"item_type_id":"2","owner":"6","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2022-10-31"},"publish_date":"2022-10-31","publish_status":"0","recid":"27721","relation_version_is_last":true,"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"],"weko_creator_id":"6","weko_shared_id":-1},"updated":"2023-05-15T19:32:36.983583+00:00"}