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2020.04.26.20081059V1.Full.Pdf medRxiv preprint doi: https://doi.org/10.1101/2020.04.26.20081059; this version posted May 4, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 1 Preliminary evidence from a multicenter prospective observational 2 study of the safety and efficacy of chloroquine for the treatment of 3 COVID-19 4 Mingxing Huang1*, Man Li2*, Fei Xiao1,2*, Jiabi Liang3*, Pengfei Pang2,4*, 5 Tiantian Tang5*, Shaoxuan Liu6, Binghui Chen7, Jingxian Shu3, Yingying You8, 2 9 10 10 11 6 Yang Li , Meiwen Tang , Jianhui Zhou , Guanmin Jiang , Jingfen Xiang , 7 Wenxin Hong12, Songmei He13, Zhaoqin Wang14, Jianhua Feng15, Changqing 8 Lin16, Yinong Ye17, Zhilong Wu18, Yaocai Li19, Bei Zhong20, Ruilin Sun21, 9 Zhongsi Hong1, Jing Liu22, Huili Chen1, Xiaohua Wang 23, Zhonghe Li 24, 10 Duanqing Pei25,26†, Lin Tian3†, Jinyu Xia1†, Shanping Jiang5†, Nanshan 11 Zhong27†, Hong Shan1,2† 12 13 1. Department of Infectious Diseases, The Fifth Affiliated Hospital, Sun 14 Yat-sen University, Zhuhai, Guangdong Province, China 15 2. Guangdong Provincial Key Laboratory of Biomedical Imaging and 16 Guangdong Provincial Engineering Research Center of Molecular 17 Imaging, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, 18 Guangdong Province, China 19 3. Department of Pharmacy, The Fifth Affiliated Hospital, Sun Yat-sen 20 University, Zhuhai, Guangdong Province, China 21 4. Interventional Medical Center, Guangdong Provincial Key 22 Laboratory of Biomedical Imaging, Zhuhai, Guangdong Province, 23 China 24 5. Department of Respiratory and Critical Care Medicine, Sun Yat-sen 25 Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong 26 Province, China 27 6. Clinical Research Center Office, The Fifth Affiliated Hospital, Sun 28 Yat-sen University, Zhuhai, Guangdong Province, China 29 7. Department of Radiology, The Fifth Affiliated Hospital, Sun Yat-sen 30 University, Zhuhai, Guangdong Province, China 1 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2020.04.26.20081059; this version posted May 4, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 31 8. Department of Oral and Maxillofacial Surgery, The Fifth Affiliated 32 Hospital, Sun Yat-sen University, Zhuhai, Guangdong Province, 33 China 34 9. Department of Hematology, The Fifth Affiliated Hospital, Sun Yat- 35 sen University, Zhuhai, Guangdong Province, China 36 10. Department of Clinical Laboratory, The Fifth Affiliated Hospital, Sun 37 Yat-sen University, Zhuhai, Guangdong Province, China 38 11. Department of Emergency, Wuhan East West Lake Mobile Cabin 39 Hospitals, Wuhan, Hubei Province, China 40 12. Department of Infectious Diseases, Guangzhou Eighth People's 41 Hospital, Guangzhou Province, Guangdong Province, China 42 13. Department of Infectious Diseases, Dongguan Ninth People's 43 Hospital, Dongguan, Guangdong Province, China 44 14. Department of Infectious Diseases, Shenzhen Third People's 45 Hospital, Shenzhen, Guangdong Province, China 46 15. Department of Infectious Diseases, Zhongshan Second People's 47 Hospital, Zhongshan, Guangdong Province, China 48 16. Department of Respiratory and Critical Care Medicine, Huizhou 49 Central People's Hospital, Huizhou, Guangdong Province, China 50 17. Department of Infectious Diseases, Foshan First people's Hospital, 51 Foshan, Guangdong Province, China 52 18. Department of Respiratory and Critical Care Medicine, Foshan 53 Fourth People's Hospital, Foshan, Guangdong Province, China 54 19. Department of Infectious Diseases, Maoming People's Hospital, 55 Maoming, Guangdong Province, China 56 20. Department of Infectious Diseases, Qingyuan People's Hospital, 57 Qingyuan, Guangdong Province, China 58 21. Department of Respiratory and Critical Care Medicine, Guangdong 59 Second People's Hospital, Guangzhou, Guangdong Province, China 60 22. Department of Respiratory and Critical Care Medicine, The Fifth 61 Affiliated Hospital, Sun Yat-sen University, Zhuhai, Guangdong 62 Province, China 63 23. Intensive Care Unit, The Fifth Affiliated Hospital, Sun Yat-sen 64 University, Zhuhai, Guangdong Province, China 2 medRxiv preprint doi: https://doi.org/10.1101/2020.04.26.20081059; this version posted May 4, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 65 24. Department of Nephropathy, The Fifth Affiliated Hospital, Sun Yat- 66 sen University, Zhuhai, Guangdong Province, China 67 25. Guangzhou Regenerative Medicine and Health Guangdong 68 Laboratory, Guangzhou, Guangdong Province, China 69 26. Guangzhou Institutes of Biomedicine and Health, Chinese Academy 70 of Sciences, Guangzhou, Guangdong Province, China 71 27. State Key Laboratory of Respiratory Diseases, The First Affiliated 72 Hospital of Guangzhou Medical University, Guangzhou, Guangdong 73 Province, China. 74 75 * These authors contributed equally. 76 † These are the co-corresponding authors. 3 medRxiv preprint doi: https://doi.org/10.1101/2020.04.26.20081059; this version posted May 4, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 77 Abstract 78 Background Effective therapies are urgently needed for the SARS-CoV-2 79 pandemic. Chloroquine has been proved to have antiviral effect against 80 coronavirus in vitro. In this study, we aimed to assess the efficacy and safety 81 of chloroquine with different doses in COVID-19. 82 Method In this multicenter prospective observational study, we enrolled 83 patients older than 18 years old with confirmed SARS-CoV-2 infection 84 excluding critical cases from 12 hospitals in Guangdong and Hubei Provinces. 85 Eligible patients received chloroquine phosphate 500mg, orally, once (half 86 dose) or twice (full dose) daily. Patients treated with non-chloroquine therapy 87 were included as historical controls. The primary endpoint is the time to 88 undetectable viral RNA. Secondary outcomes include the proportion of 89 patients with undetectable viral RNA by day 10 and 14, hospitalization time, 90 duration of fever, and adverse events. 91 Results A total of 197 patients completed chloroquine treatment, and 176 92 patients were included as historical controls. The median time to achieve an 93 undetectable viral RNA was shorter in chloroquine than in non-chloroquine 94 (absolute difference in medians -6.0 days; 95% CI -6.0 to -4.0). The duration 95 of fever is shorter in chloroquine (geometric mean ratio 0.6; 95% CI 0.5 to 0.8). 96 No serious adverse events were observed in the chloroquine group. Patients 97 treated with half dose experienced lower rate of adverse events than with full 98 dose. 99 Conclusions Although randomised trials are needed for further evaluation, this 100 study provides evidence for safety and efficacy of chloroquine in COVID-19 101 and suggests that chloroquine can be a cost-effective therapy for combating 4 medRxiv preprint doi: https://doi.org/10.1101/2020.04.26.20081059; this version posted May 4, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 102 the COVID-19 pandemic. 5 medRxiv preprint doi: https://doi.org/10.1101/2020.04.26.20081059; this version posted May 4, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 103 Introduction 104 The coronavirus disease 2019 (COVID-19) emerged in late 2019, 105 originating from Wuhan China1,2. The responsible virus, severe acute 106 respiratory syndrome coronavirus 2 (SARS-CoV-2), belongs to a distinct clade 107 from the human severe acute respiratory syndrome CoV (SARS-CoV) and 108 Middle East respiratory syndrome CoV (MERS-CoV)3. It has become a global 109 pandemic, affecting over 100 countries with more than 240,000 confirmed 110 cases and over 10,000 deaths globally as of March 20, 2020, calling for an 111 urgent demand of effective treatment. 112 Chloroquine has been proved effective in vitro to inhibit the replication 113 of SARS-CoV4, HCoV-229E5, and the newly discovered SARS-CoV-26,7. To 114 evaluate the efficacy and safety of chloroquine for COVID-19, we previously 115 conducted a single-arm pilot clinical study with 10 patients (Huang et al. 116 Journal of Molecular Cell Biology, in press). Encouragingly, all patients 117 achieved undetectable level of viral RNA within 14 days without serious 118 adverse events. These results led us to conduct a multicenter prospective 119 observational study in adult patients with COVID-19 to assess the efficacy 120 and safety of chloroquine for COVID-19. 121 122 Result 123 Patients 124 Of the 233 enrolled patients for chloroquine, 197 (84.5%) completed 125 treatment and were included in the final analysis (Figure 1, study flowchart; 126 Supplementary Table 1). Of the 182 patients collected as historical controls, 127 176 (96.7%) were included in the final analysis. Their baseline demographic 128 and clinical features are listed in Table 1. The median age of patients were 43 6 medRxiv preprint doi: https://doi.org/10.1101/2020.04.26.20081059; this version posted May 4, 2020.
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