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

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

Mingxing Huang, Man Li, Fei Xiao, Jiabi Liang, Pen gfei Pang, Tiantian Tang, Shaoxuan Liu, Binghui Ch en, Jingxian Shu, Yingying You, Yang Li, Meiwen Ta ng, Jianhui Zhou, Guanmin Jiang, Jingfen Xiang, We nxin Hong, Songmei He, Zhaoqin Wang, Jianhua Feng, Changqing Lin, Yinong Ye, Zhilong Wu, Yaocai Li, Bei Zhong, Ruilin Sun, Zhongsi Hong, Jing Liu, Hui li Chen, Xiaohua Wang, Zhonghe Li, Duanqing Pei, L in Tian, Jinyu Xia, Shanping Jiang, Nanshan Zhong, Hong Shan
doi: https://doi.org/10.1101/2020.04.26.20081059
This article is a preprint and has not been peer-reviewed [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

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Abstract


Background 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. Method 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 500mg, 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. Results 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. Conclusions Although randomised 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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https://www.medrxiv.org/content/10.1....26.20081059v1