Preliminary evidence from a multicenter prospective observational study of the safety and efficacy of chloroquine for the treatment of COVID-19
Preliminary evidence from a multicenter prospective observational study of the safety and efficacy of chloroquine for the treatment of COVID-19
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DOI：
10.1093/nsr/nwaa113
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发表时间：
2020-09-01
影响因子：
20.6
通讯作者：
Shan, Hong
中科院分区：
文献类型：
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作者：
Huang, Mingxing;Li, Man;Shan, Hong
SARS-CoV-2大流行迫切需要有效的治疗方法。氯喹已被证明在体外具有抗冠状病毒的作用。在这项研究中，我们旨在评估不同剂量的氯喹在COVID-19中的有效性和安全性。在这项多中心前瞻性观察性研究中，我们从广东省和湖北省的12家医院招募了年龄大于18岁的确诊SARS-CoV-2感染患者（不包括危重病例）。合格患者接受磷酸氯喹500 mg，口服，每日一次（半剂量）或两次（全剂量）。接受非氯喹治疗的患者作为历史对照。主要终点是至检测不到病毒RNA的时间。次要结果包括第10天和第14天检测不到病毒RNA的患者比例、住院时间、发热持续时间和不良事件。共有197名患者完成了氯喹治疗，176名患者被纳入作为历史对照。氯喹组达到病毒RNA检测不到的中位时间短于非氯喹组（中位绝对差异为-6.0天; 95% CI为-6.0至-4.0）。氯喹组的发热持续时间较短（几何平均数比0.6; 95% CI 0.5 - 0.8）。氯喹组无严重不良反应。接受半剂量治疗的患者的不良事件发生率低于接受全剂量治疗的患者。尽管还需要随机试验进行进一步评估，但这项研究为氯喹在COVID-19中的安全性和有效性提供了证据，并表明氯喹可以成为抗击COVID-19大流行的成本效益疗法。
Effective therapies are urgently needed for the SARS-CoV-2 pandemic. Chloroquine has been proved to have antiviral effect against coronavirus in vitro. In this study, we aimed to assess the efficacy and safety of chloroquine with different doses in COVID-19. In this multicenter prospective observational study, we enrolled patients older than 18 years old with confirmed SARS-CoV-2 infection excluding critical cases from 12 hospitals in Guangdong and Hubei Provinces. Eligible patients received chloroquine phosphate 500 mg, orally, once (half dose) or twice (full dose) daily. Patients treated with non-chloroquine therapy were included as historical controls. The primary endpoint is the time to undetectable viral RNA. Secondary outcomes include the proportion of patients with undetectable viral RNA by day 10 and 14, hospitalization time, duration of fever, and adverse events. A total of 197 patients completed chloroquine treatment, and 176 patients were included as historical controls. The median time to achieve an undetectable viral RNA was shorter in chloroquine than in non-chloroquine (absolute difference in medians -6.0 days; 95% CI -6.0 to -4.0). The duration of fever is shorter in chloroquine (geometric mean ratio 0.6; 95% CI 0.5 to 0.8). No serious adverse events were observed in the chloroquine group. Patients treated with half dose experienced lower rate of adverse events than with full dose. Although randomized trials are needed for further evaluation, this study provides evidence for safety and efficacy of chloroquine in COVID-19 and suggests that chloroquine can be a cost-effective therapy for combating the COVID-19 pandemic.