Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.06.19.20136093; this version posted June 22, 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(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
Efficacy and safety of chloroquine or hydroxychloroquine in moderate
type of COVID-19: a prospective open-label randomized controlled study
Lan Chen1, Zhen-Yu Zhang1, Jian-Guo Fu1, Zhi-Peng Feng1, Su-Zhen Zhang1,
Qiu-Ying Han1, Xiao-Bin Zhang1, Xiong Xiao2, Hui-Min Chen3, Li-Long Liu4,
Xian-Li Chen5, Yu-Pei Lan6, De-Jin Zhong7, Lan Hu8, Jun-Hui Wang8, Xing-Hua Yu1,
Dan-Yang She9*, Yong-Hong Zhu10* and Zhen-Yu Yin1*
1
Zhongshan Hospital, Xiamen University, Xiamen, Fujian, China;
2
Department of Respiratory, Xiamen Branch of Zhongshan Hospital Affiliated to
Fudan University, Xiamen, Fujian, China;
3
Department of Intensive Care Unit, Xiamen Third Hospital, Xiamen, Fujian, China;
4
Department of Infectious Disease, Hongai Hospital, Xiamen, Fujian, China;
5
Department of Infectious Disease, Xiang'an Hospital Affiliated to Xiamen
University, Xiamen, Fujian, China;
6
General Office, Xiamen Haicang Hospital, Xiamen, Fujian, China;
7
Department of Gastroenterology, Xiamen Changgen Hospital, Xiamen, Fujian,
China;
8
Optics Valley Branch of Tongji Hospital, Tongji Medical College, Huazhong
University of Science and Technology Wuhan, Wuhan, Hubei, China.
9
Department of Pulmonary and Critical Care Medicine, the First Medical Center of
Chinese PLA General Hospital, Beijing 100853, China
10
Early Clinical Development of Immunology, Infectious Disease and Ophthalmology,
Roche Innovation Center, Shanghai 201203, China
*
Corresponding author:
Zhen-Yu Yin
Zhongshan Hospital, Xiamen University,
Department of Hepatobiliary Surgery
201, Hubin South Road, Siming qu
Xiamen, Fujian 361004, China
E-mail: yinzy@xmu.edu.cn
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.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/10.1101/2020.06.19.20136093; this version posted June 22, 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(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
Dan-Yang She*
Department of Pulmonary and Critical Care Medicine, the First Medical Center of
Chinese PLA General Hospital, Beijing 100853, China
E-mail: dysheh@163.com
Yong-Hong Zhu*
Early Clinical Development of Immunology, Infectious Disease and Ophthalmology,
Roche Innovation Center, Shanghai 201203, China
E-mail: yonghong.zhu.yz2@roche.com
Key words: coronavirus disease 2019, COVID-19, SARS-CoV-2, chloroquine,
hydroxychloroquine, time to clinical recovery
RUNNING TITLE: (hydroxy)chloroquine in treating COVID-19
CONFLICT OF INTEREST
The authors declare no conflict of interest regarding the contents of this article.
FUNDING
This study was funded by the Medical and Health Key project of Xiamen
(3502Z20191106), which is a project of the Xiamen Science and Technology Bureau
(3502Z20194016).
Target journal: Clinical and Translational Science
Word count: 5795
Abstract: 237 (max 250)
Text: 3977 (max 4000)
Tables/figures: 3+2 (max 7)
References:22 (max 50)
medRxiv preprint doi: https://doi.org/10.1101/2020.06.19.20136093; this..
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'abstract': '<jats:title>ABSTRACT</jats:title><jats:p>The outbreak of novel coronavirus disease 2019 '
'(COVID-19) has become a pandemic. Drug repurposing may represent a rapid way to fill the '
'urgent need for effective treatment. We evaluated the clinical utility of chloroquine and '
'hydroxychloroquine in treating COVID-19.</jats:p><jats:p>Forty-eight patients with moderate '
'COVID-19 were randomized to oral treatment with chloroquine (1000 mg QD on Day 1, then 500 mg '
'QD for 9 days; n=18), hydroxychloroquine (200 mg BID for 10 days; n=18), or control treatment '
'(n=12).</jats:p><jats:p>Adverse events were mild, except for one case of Grade 2 ALT '
'elevation. Adverse events were more commonly observed in the chloroquine group (44.44%) and '
'the hydroxychloroquine group (50.00%) than in the control group (16.67%). The chloroquine '
'group achieved shorter time to clinical recovery (TTCR) than the control group (P=0.019). '
'There was a trend toward reduced TTCR in the hydroxychloroquine group (P=0.049). The time to '
'reach viral RNA negativity was significantly faster in the chloroquine group and the '
'hydroxychloroquine group than in the control group (P=0.006 and P=0.010, respectively). The '
'median numbers of days to reach RNA negativity in the chloroquine, hydroxychloroquine, and '
'control groups was 2.5 (IQR: 2.0-3.8) days, 2.0 (IQR: 2.0-3.5) days, and 7.0 (IQR: 3.0-10.0) '
'days, respectively. The chloroquine and hydroxychloroquine groups also showed trends toward '
'improvement in the duration of hospitalization and findings on lung computerized tomography '
'(CT). This study provides evidence that (hydroxy)chloroquine may be used effectively in '
'treating moderate COVID-19 and supports larger trials.</jats:p>',
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