Saghir Sultan A M, AlGabri Naif A, Alagawany Mahmoud M, Attia Youssef A, Alyileili Salem R, Elnesr Shaaban S, Shafi Manal E, Al-Shargi Omar Y A, Al-Balagi Nader, Alwajeeh Abdullah S, Alsalahi Omar S A, Patra Amlan K, Khafaga Asmaa F, Negida Ahmed, Noreldin Ahmed, Al-Amarat Wesam, Almaiman Amer A, El-Tarabily Khaled A, Abd El-Hack Mohamed E
Department of Medical Analysis, Princess Aisha Bint Al-Hussein College of Nursing and Medical Sciences, Al-Hussein Bin Talal University, Ma'an, 71111, Jordan.
Pathology Department, Faculty of Veterinary Medicine, Thamar University, Dhamar, Yemen.
Ther Clin Risk Manag. 2021 Apr 28;17:371-387. doi: 10.2147/TCRM.S301817. eCollection 2021.
In December 2019, the novel coronavirus disease pandemic (COVID-19) that began in China had infected so far more than 109,217,366 million individuals worldwide and accounted for more than 2,413,912 fatalities. With the dawn of this novel coronavirus (SARS-CoV-2), there was a requirement to select potential therapies that might effectively kill the virus, accelerate the recovery, or decrease the case fatality rate. Besides the currently available antiviral medications for human immunodeficiency virus (HIV) and hepatitis C virus (HCV), the chloroquine/hydroxychloroquine (CQ/HCQ) regimen with or without azithromycin has been repurposed in China and was recommended by the National Health Commission, China in mid-February 2020. By this time, the selection of this regimen was based on its efficacy against the previous SARS-CoV-1 virus and its potential to inhibit viral replication of the SARS-CoV-2 in vitro. There was a shortage of robust clinical proof about the effectiveness of this regimen against the novel SARS-CoV-2. Therefore, extensive research effort has been made by several researchers worldwide to investigate whether this regimen is safe and effective for the management of COVID-19. In this review, we provided a comprehensive overview of the CQ/HCQ regimen, summarizing data from in vitro studies and clinical trials for the protection against or the treatment of SARS-CoV-2. Despite the initial promising results from the in vitro studies and the widespread use of CQ/HCQ in clinical settings during the 1st wave of COVID-19, current data from well-designed randomized controlled trials showed no evidence of benefit from CQ/HCQ supplementation for the treatment or prophylaxis against SARS-CoV-2 infection. Particularly, the two largest randomized controlled trials to date (RECOVERY and WHO SOLIDARITY trials), both confirmed that CQ/HCQ regimen does not provide any clinical benefit for COVID-19 patients. Therefore, we do not recommend the use of this regimen in COVID-19 patients outside the context of clinical trials.
2019年12月，始于中国的新型冠状病毒病大流行（COVID-19）迄今已感染全球超过1.09217366亿人，死亡人数超过241.3912万。随着这种新型冠状病毒（SARS-CoV-2）的出现，需要选择可能有效杀死病毒、加速康复或降低病死率的潜在疗法。除了目前可用于治疗人类免疫缺陷病毒（HIV）和丙型肝炎病毒（HCV）的抗病毒药物外，含或不含阿奇霉素的氯喹/羟氯喹（CQ/HCQ）疗法在中国已被重新启用，并于2020年2月中旬得到中国国家卫生健康委员会的推荐。此时，选择该疗法是基于其对先前的SARS-CoV-1病毒的疗效以及在体外抑制SARS-CoV-2病毒复制的潜力。关于该疗法对新型SARS-CoV-2的有效性，缺乏有力的临床证据。因此，全球多位研究人员进行了广泛的研究工作，以调查该疗法用于管理COVID-19是否安全有效。在本综述中，我们全面概述了CQ/HCQ疗法，总结了来自体外研究和临床试验的数据，以了解其对SARS-CoV-2的预防或治疗作用。尽管体外研究最初取得了令人鼓舞的结果，且在COVID-19第一波疫情期间CQ/HCQ在临床环境中广泛使用，但目前来自精心设计的随机对照试验的数据表明，补充CQ/HCQ对治疗或预防SARS-CoV-2感染没有益处。特别是，迄今为止两项最大规模的随机对照试验（RECOVERY试验和世界卫生组织团结试验）均证实，CQ/HCQ疗法对COVID-19患者没有任何临床益处。因此，我们不建议在临床试验之外的COVID-19患者中使用该疗法。
