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Efficacy and safety of chloroquine or hydroxychloroquine in moderate type of COVID-19: a prospective open-label randomized controlled study

Chen et al., medRxiv, doi:10.1101/2020.06.19.20136093

Jun 2020

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HCQ for COVID-19

1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 423 studies, used in 59 countries.

Lower risk for mortality, hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments.

5,500+ studies for 119 treatments. c19hcq.org

RCT 48 hospitalized patients in China showing faster clinical recovery and viral clearance with CQ/HCQ.

Standard of Care (SOC) for COVID-19 in the study country, China, is poor with low average efficacy for approved treatments1.

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time to clinical recovery, 20.0% lower, relative time 0.80, p = 0.51, treatment median 6.0 IQR 5.0 n=18, control median 7.5 IQR 11.25 n=12, HCQ.

time to clinical recovery, 26.7% lower, relative time 0.73, p = 0.36, treatment median 5.5 IQR 4.25 n=18, control median 7.5 IQR 11.25 n=12, CQ.

median time to PCR-, 71.4% lower, relative time 0.29, p < 0.001, treatment median 2.0 IQR 1.5 n=18, control median 7.0 IQR 7.0 n=12, HCQ.

median time to PCR-, 64.3% lower, relative time 0.36, p = 0.001, treatment median 2.5 IQR 1.8 n=18, control median 7.0 IQR 7.0 n=12, CQ.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. c19early.org, c19early.org/soc/china.html.c19early.org/soc/china.html.

Chen et al., 22 Jun 2020, Randomized Controlled Trial, China, preprint, 19 authors, study period 18 February, 2020 - 30 March, 2020, dosage 200mg bid days 1-10.

This Paper HCQ All

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 The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.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..

DOI record: { "DOI": "10.1101/2020.06.19.20136093", "URL": "http://dx.doi.org/10.1101/2020.06.19.20136093", "abstract": "ABSTRACTThe 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.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).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.", "accepted": { "date-parts": [ [ 2020, 6, 22 ] ] }, "author": [ { "ORCID": "http://orcid.org/0000-0003-4520-5109", "affiliation": [], "authenticated-orcid": false, "family": "Chen", "given": "Lan", "sequence": "first" }, { "affiliation": [], "family": "Zhang", "given": "Zhen-Yu", "sequence": "additional" }, { "affiliation": [], "family": "Fu", "given": "Jian-Guo", "sequence": "additional" }, { "affiliation": [], "family": "Feng", "given": "Zhi-Peng", "sequence": "additional" }, { "affiliation": [], "family": "Zhang", "given": "Su-Zhen", "sequence": "additional" }, { "affiliation": [], "family": "Han", "given": "Qiu-Ying", "sequence": "additional" }, { "affiliation": [], "family": "Zhang", "given": "Xiao-Bin", "sequence": "additional" }, { "affiliation": [], "family": "Xiao", "given": "Xiong", "sequence": "additional" }, { "affiliation": [], "family": "Chen", "given": "Hui-Min", "sequence": "additional" }, { "affiliation": [], "family": "Liu", "given": "Li-Long", "sequence": "additional" }, { "affiliation": [], "family": "Chen", "given": "Xian-Li", "sequence": "additional" }, { "affiliation": [], "family": "Lan", "given": "Yu-Pei", "sequence": "additional" }, { "affiliation": [], "family": "Zhong", "given": "De-Jin", "sequence": "additional" }, { "affiliation": [], "family": "Hu", "given": "Lan", "sequence": "additional" }, { "affiliation": [], "family": "Wang", "given": "Jun-Hui", "sequence": "additional" }, { "affiliation": [], "family": "Yu", "given": "Xing-Hua", "sequence": "additional" }, { "affiliation": [], "family": "She", "given": "Dan-Yang", "sequence": "additional" }, { "affiliation": [], "family": "Zhu", "given": "Yong-Hong", "sequence": "additional" }, { "affiliation": [], "family": "Yin", "given": "Zhen-Yu", "sequence": "additional" } ], "container-title": [], "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2020, 6, 22 ] ], "date-time": "2020-06-22T23:05:24Z", "timestamp": 1592867124000 }, "deposited": { "date-parts": [ [ 2021, 1, 5 ] ], "date-time": "2021-01-05T15:15:32Z", "timestamp": 1609859732000 }, "group-title": "Infectious Diseases (except HIV/AIDS)", "indexed": { "date-parts": [ [ 2024, 2, 8 ] ], "date-time": "2024-02-08T18:07:40Z", "timestamp": 1707415660428 }, "institution": [ { "name": "medRxiv" } ], "is-referenced-by-count": 28, "issued": { "date-parts": [ [ 2020, 6, 22 ] ] }, "link": [ { "URL": "https://syndication.highwire.org/content/doi/10.1101/2020.06.19.20136093", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "246", "original-title": [], "posted": { "date-parts": [ [ 2020, 6, 22 ] ] }, "prefix": "10.1101", "published": { "date-parts": [ [ 2020, 6, 22 ] ] }, "publisher": "Cold Spring Harbor Laboratory", "reference": [ { "DOI": "10.1001/jama.2020.1097", "doi-asserted-by": "crossref", "key": "2021010505550617000_2020.06.19.20136093v1.1", "unstructured": "Phelan AL , Katz R , Gostin LO . 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Late treatment
is less effective

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