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. 2020 May 28;7(9):1428-1436.
doi: 10.1093/nsr/nwaa113. eCollection 2020 Sep.

Preliminary evidence from a multicenter prospective observational study of the safety and efficacy of chloroquine for the treatment of COVID-19

Mingxing Huang  1 , Man Li  2 , Fei Xiao  1 , Pengfei Pang  2 , Jiabi Liang  3 , Tiantian Tang  4 , Shaoxuan Liu  5 , Binghui Chen  6 , Jingxian Shu  3 , Yingying You  7 , Yang Li  2 , Meiwen Tang  8 , Jianhui Zhou  9 , Guanmin Jiang  9 , Jingfen Xiang  10 , Wenxin Hong  11 , Songmei He  12 , Zhaoqin Wang  13 , Jianhua Feng  14 , Changqing Lin  15 , Yinong Ye  16 , Zhilong Wu  17 , Yaocai Li  18 , Bei Zhong  19 , Ruilin Sun  20 , Zhongsi Hong  1 , Jing Liu  21 , Huili Chen  1 , Xiaohua Wang  22 , Zhonghe Li  23 , Duanqing Pei  24 , Lin Tian  25 , Jinyu Xia  1 , Shanping Jiang  4 , Nanshan Zhong  26 , Hong Shan  2
Affiliations

Preliminary evidence from a multicenter prospective observational study of the safety and efficacy of chloroquine for the treatment of COVID-19

Mingxing Huang et al. Natl Sci Rev. .

Abstract

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.

Keywords: COVID-19; SARS-CoV-2; chloroquine; treatment.

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Figures

Figure 1.
Figure 1.
Study flowchart.
Figure 2.
Figure 2.
Kaplan-Meier curve for time to undetectable viral RNA comparing treatment groups.
Figure 3.
Figure 3.
Post hoc analysis on the effect of chloroquine on time to undetectable viral RNA by stratification. Abbreviations: GD, Guangdong; HB, Hubei. 95% CI are calculated by bootstrapping. The differences for all other variables are the absolute difference between chloroquine group and non-chloroquine group.
See this image and copyright information in PMC

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