{"created":"2023-05-15T16:49:27.789305+00:00","id":26929,"links":{},"metadata":{"_buckets":{"deposit":"b2a2a701-77ec-42e5-9ff3-ea0f559c9b27"},"_deposit":{"created_by":6,"id":"26929","owners":[6],"pid":{"revision_id":0,"type":"depid","value":"26929"},"status":"published"},"_oai":{"id":"oai:nagasaki-u.repo.nii.ac.jp:00026929","sets":["10:11"]},"author_link":["119779","119775","119782","119783","119781","119780","119778","119777","119776"],"item_2_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2021-09-21","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"9","bibliographicPageStart":"e053325","bibliographicVolumeNumber":"11","bibliographic_titles":[{"bibliographic_title":"BMJ Open"}]}]},"item_2_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Introduction: The COVID-19 pandemic has emerged worldwide. Although several medications have been approved for treating moderate-to-severe COVID-19, very few treatment strategy has been established for patients with mild COVID-19 who do not require oxygen administration. Clarithromycin is a macrolide antimicrobial agent that has been widely used for bacterial respiratory infectious diseases. Clarithromycin also acts an immunomodulating drug and suppresses cytokine storms in viral respiratory diseases, including influenza. In this study, we aim to evaluate the efficacy of clarithromycin in patients with mild COVID-19.\nMethods and analysis: This is an exploratory, multicentre, open-label, randomised controlled trial. This study was initiated in May 2021 and will end in July 2022. Patients with mild COVID-19 pneumonia who do not require oxygen administration will be enrolled and randomly assigned in a 1:1:1 ratio to group A (administration of clarithromycin 800 mg/day), group B (administration of clarithromycin 400 mg/day) or group C (standard treatment without clarithromycin). The planned number of enrolled patients is 60 (20 patients × three groups). The primary endpoint is the number of days required to improve the clinical symptoms as measured by the severity score. Secondary endpoints include days for recovery of the body temperature, proportion of patients with oxygen administration, inflammatory cytokines, viral load, serum immunoglobulins, peripheral blood lymphocytes, blood biomarkers and pneumonia infiltrations.\nEthics and dissemination: The study protocol was approved by the Clinical Research Review Board of Nagasaki University in accordance with the Clinical Trials Act in Japan. The study will be conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act and other current legal regulations in Japan. Written informed consent will be obtained from all the participants. The results of this study will be reported as journal publications.\nTrial registration number: jRCTs071210011.","subitem_description_type":"Abstract"}]},"item_2_description_63":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"BMJ Open, 11(9), art. no. e053325; 2021","subitem_description_type":"Other"}]},"item_2_publisher_33":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"BMJ Publishing Group Ltd."}]},"item_2_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1136/bmjopen-2021-053325","subitem_relation_type_select":"DOI"}}]},"item_2_rights_13":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.  This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/."}]},"item_2_source_id_7":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"2044-6055","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":"Yamamoto, Kazuko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Hosogaya, Naoki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Sakamoto, Noriho"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yoshida, Haruo"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Ishii, Hiroshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yatera, Kazuhiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Izumikawa, Koichi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yanagihara, Katsunori"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Mukae, Hiroshi"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2021-12-09"}],"displaytype":"detail","filename":"BMJOpen11_e05332.pdf","filesize":[{"value":"501.8 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"BMJOpen11_e05332.pdf","url":"https://nagasaki-u.repo.nii.ac.jp/record/26929/files/BMJOpen11_e05332.pdf"},"version_id":"053c319b-77a6-44d7-95b5-e32401b8e13b"}]},"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":"Efficacy of clarithromycin in patients with mild COVID-19 pneumonia not receiving oxygen administration: protocol for an exploratory, multicentre, open-label, randomised controlled trial (CAME COVID-19 study)","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Efficacy of clarithromycin in patients with mild COVID-19 pneumonia not receiving oxygen administration: protocol for an exploratory, multicentre, open-label, randomised controlled trial (CAME COVID-19 study)"}]},"item_type_id":"2","owner":"6","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2021-12-09"},"publish_date":"2021-12-09","publish_status":"0","recid":"26929","relation_version_is_last":true,"title":["Efficacy of clarithromycin in patients with mild COVID-19 pneumonia not receiving oxygen administration: protocol for an exploratory, multicentre, open-label, randomised controlled trial (CAME COVID-19 study)"],"weko_creator_id":"6","weko_shared_id":-1},"updated":"2023-05-15T20:06:02.781389+00:00"}