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.

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一项关于氯喹治疗 COVID-19 的安全性和有效性的多中心前瞻性观察研究的初步证据

SARS-CoV-2 大流行急需有效疗法。体外实验证明氯喹对冠状病毒有抗病毒作用. 在这项研究中，我们旨在评估不同剂量的氯喹在 COVID-19 中的疗效和安全性。在这项多中心前瞻性观察性研究中，我们招募了 18 岁以上确诊感染 SARS-CoV-2 的患者，不包括广东省和湖北省 12 家医院的危重病例。符合条件的患者每天口服 500 毫克磷酸氯喹，一次（半剂量）或两次（全剂量）。接受非氯喹治疗的患者被纳入作为历史对照。主要终点是检测不到病毒 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，其中 176 名患者被纳入作为历史对照。氯喹达到无法检测到病毒 RNA 的中位时间比非氯喹短（中位数的绝对差异为 -6.0 天；95% CI -6.0 至 -4.0）。氯喹的发热持续时间较短（几何平均比为 0.6；95% CI 为 0.5 至 0.8）。氯喹组未观察到严重不良事件。接受半剂量治疗的患者的不良事件发生率低于全剂量治疗。尽管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对抗 COVID-19 大流行的一种具有成本效益的疗法。氯喹的发热持续时间较短（几何平均比为 0.6；95% CI 为 0.5 至 0.8）。氯喹组未观察到严重不良事件。接受半剂量治疗的患者的不良事件发生率低于全剂量治疗。尽管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对抗 COVID-19 大流行的一种具有成本效益的疗法。氯喹的发热持续时间较短（几何平均比为 0.6；95% CI 为 0.5 至 0.8）。氯喹组未观察到严重不良事件。接受半剂量治疗的患者的不良事件发生率低于全剂量治疗。尽管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对抗 COVID-19 大流行的一种具有成本效益的疗法。