Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan
Clinical Research Center, National Organization Hospital Nagasaki Medical Center, Omura, Japan.
BMJ Open. 2021 Sep 21;11(9):e053325. doi: 10.1136/bmjopen-2021-053325.
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.
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.
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.
jRCTs071210011.
COVID-19 大流行在全球范围内出现。尽管已经批准了几种药物来治疗中重度 COVID-19，但对于不需要吸氧的轻度 COVID-19 患者，很少有治疗策略。克拉霉素是一种广泛用于治疗细菌呼吸道感染的大环内酯类抗菌药物。克拉霉素还具有免疫调节作用，可以抑制包括流感在内的病毒性呼吸道疾病中的细胞因子风暴。在这项研究中，我们旨在评估克拉霉素治疗轻度 COVID-19 患者的疗效。
这是一项探索性、多中心、开放标签、随机对照试验。该研究于 2021 年 5 月启动，将于 2022 年 7 月结束。招募不需要吸氧的轻度 COVID-19 肺炎患者，并按 1:1:1 的比例随机分为 A 组（每天给予克拉霉素 800mg）、B 组（每天给予克拉霉素 400mg）或 C 组（不给予克拉霉素的标准治疗）。计划入组患者为 60 例（每组 20 例）。主要终点是通过严重程度评分测量临床症状改善所需的天数。次要终点包括体温恢复、需要吸氧的患者比例、炎症细胞因子、病毒载量、血清免疫球蛋白、外周血淋巴细胞、血液生物标志物和肺炎浸润的天数。
该研究方案已获得长崎大学临床研究审查委员会根据日本临床试验法的批准。该研究将按照赫尔辛基宣言、临床试验法和日本现行其他法律法规进行。将从所有参与者处获得书面知情同意。本研究结果将以期刊发表的形式报告。
jRCTs071210011。
