Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial.
Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial.
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DOI：
10.1016/s2213-2600(21)00263-0
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发表时间：
2021-10
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影响因子：
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通讯作者：
Richards D
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作者：
Hinks TSC;Cureton L;Knight R;Wang A;Cane JL;Barber VS;Black J;Dutton SJ;Melhorn J;Jabeen M;Moss P;Garlapati R;Baron T;Johnson G;Cantle F;Clarke D;Elkhodair S;Underwood J;Lasserson D;Pavord ID;Morgan S;Richards D
阿奇霉素的抗菌、抗炎和抗病毒特性表明了其对COVID-19的治疗潜力。轻中度疾病的随机化数据不可用。我们评估了阿奇霉素是否能有效减少轻中度COVID-19患者的住院率。这项前瞻性、开放标签、随机优效性试验在英国的19家医院进行。我们招募了至少18岁的成年人，他们因临床诊断、高度可能或确诊的COVID-19感染而到医院就诊，症状少于14天，被认为适合进行初始门诊管理。患者被随机分配（1：1）到阿奇霉素（500毫克，每天一次，口服14天）加标准治疗或标准治疗。主要结局是随机化后28天内死亡或因任何原因住院。根据意向治疗原则评估主要结局和安全性结局。本试验在ClinicalTrials.gov（NCT 04381962）上注册，招募已关闭。298名参与者于2020年6月3日至2021年1月29日入组。3名参与者撤回同意并要求删除所有数据，另外3名参与者在随机化后撤回同意，因此，在292名参与者中评估了主要结局（阿奇霉素组145名，标准治疗组147名）。参与者的平均年龄为45.9岁（SD 14.9）。阿奇霉素组15例（10%）受试者和标准治疗组17例（12%）受试者在研究期间住院或死亡（校正OR 0.91 [95%CI 0.43 - 1.92]，p= 0.80）。未报告严重不良事件。在未入院治疗的轻中度COVID-19患者中，在标准治疗中添加阿奇霉素并不能降低随后入院或死亡的风险。我们的研究结果不支持阿奇霉素用于轻中度COVID-19患者。国家健康研究所牛津生物医学研究中心，牛津大学和辉瑞公司。
The antibacterial, anti-inflammatory, and antiviral properties of azithromycin suggest therapeutic potential against COVID-19. Randomised data in mild-to-moderate disease are not available. We assessed whether azithromycin is effective in reducing hospital admission in patients with mild-to-moderate COVID-19. This prospective, open-label, randomised superiority trial was done at 19 hospitals in the UK. We enrolled adults aged at least 18 years presenting to hospitals with clinically diagnosed, highly probable or confirmed COVID-19 infection, with fewer than 14 days of symptoms, who were considered suitable for initial ambulatory management. Patients were randomly assigned (1:1) to azithromycin (500 mg once daily orally for 14 days) plus standard care or to standard care alone. The primary outcome was death or hospital admission from any cause over the 28 days from randomisation. The primary and safety outcomes were assessed according to the intention-to-treat principle. This trial is registered at ClinicalTrials.gov (NCT04381962) and recruitment is closed. 298 participants were enrolled from June 3, 2020, to Jan 29, 2021. Three participants withdrew consent and requested removal of all data, and three further participants withdrew consent after randomisation, thus, the primary outcome was assessed in 292 participants (145 in the azithromycin group and 147 in the standard care group). The mean age of the participants was 45·9 years (SD 14·9). 15 (10%) participants in the azithromycin group and 17 (12%) in the standard care group were admitted to hospital or died during the study (adjusted OR 0·91 [95% CI 0·43–1·92], p=0·80). No serious adverse events were reported. In patients with mild-to-moderate COVID-19 managed without hospital admission, adding azithromycin to standard care treatment did not reduce the risk of subsequent hospital admission or death. Our findings do not support the use of azithromycin in patients with mild-to-moderate COVID-19. National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford and Pfizer.