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Confidential: for Review Only Hydroxychloroquine in Patients Mainly with Mild to Moderate COVID–19: an Open–Label, Randomized, Controlled Trial

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Confidential: for Review Only Hydroxychloroquine in Patients Mainly with Mild to Moderate COVID–19: an Open–Label, Randomized, Controlled Trial BMJ Confidential: For Review Only Hydroxychloroquine in patients mainly with mild to moderate COVID–19: an open–label, randomized, controlled trial Journal: BMJ Manuscript ID BMJ-2020-056844.R1 Article Type: Research BMJ Journal: BMJ Date Submitted by the 22-Apr-2020 Author: Complete List of Authors: Tang, Wei; Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Cao, Zhujun; Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Han, Mingfeng; Department of Respiratory Medicine. No.2 people's hospital of Fuyang city, Fuyang, Anhui, China Wang, Zhengyan; Department of Respiratory Medicine, Suizhou Hospital, Hubei University of Medicine, Suizhou, Hubei, China Chen, Junwen; Xiangyang No.1 People’s Hospital Affiliated hospital of Hubei University of Medicine Sun, Wenjin; Department of Infectious Diseases, Central Hospital of Ezhou, Ezhou, Hubei, China Wu, Yaojie; Department of Cardiovascular Medicine, Yunmeng people's hospital, Xiaogan, Hubei, China Xiao, Wei; The First People’s Hospital of Jingzhou. Liu, Shengyong; Department of Infectious Diseases, Xiaogan hospital affiliated to Wuhan university of science and technology, Xiaogan, Hubei, China Chen, Erzhen; Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Chen, Wei; Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Wang, Xiongbiao; Department of respiratory medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China Yang, Jiuyong; Department of Respiratory Medicine, Hubei Space Hospital of Xiaogan, Xiaogan, Hubei, China Lin, Jun; Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China Zhao, Qingxia; The Sixth People’s Hospital of Zhengzhou, Department of Infectious Disease Yan, Youqin; Department of Infectious Disease, Wuhan No.7 Hospital, Wuhan, Hubei, China Xie, Zhibin; Departments of Respiratory Medicine, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, https://mc.manuscriptcentral.com/bmj Page 1 of 39 BMJ 1 2 3 Hubei, China 4 Li, Dan; Department of Respiratory Medicine, The Third People’s Hospital 5 of Yichang, Yichang, Hubei, China 6 Yang, Yaofeng; Department of Respiratory Medicine, Xiao Gan First 7 People’s Hospital, Xiaogan, Hubei province, China 8 Liu, Leshan; Clinical Research Center, Ruijin Hospital, Shanghai Jiao 9 Tong University School of Medicine, Shanghai, China Qu, Jieming; Rui Jin Hospital, School of Medicine, Shanghai Jiaotong 10 Confidential:University, Department For ofReview Respiratory Medicine Only 11 Ning, Guang; Shanghai Jiaotong University School of Medicine 12 Shi, Guochao; Department of Pulmonary and Critical Care Medicine, 13 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 14 Shanghai, China 15 Xie, Qing; Department of Infectious Disease, Ruijin Hospital, Shanghai 16 Jiao Tong University School of Medicine, Shanghai, China 17 Coronavirus disease, hydroxychloroquine, clinical oucome, treatment, Keywords: 18 novel coronavirus, SARS-CoV-2, negative conversion, adverse event 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 2 of 39 1 2 3 1 TITLE PAGE 4 5 2 Title: Hydroxychloroquine in patients mainly with mild to moderate COVID–19: an open–label, 6 7 8 3 randomized, controlled trial 9 10 4 Running title: Hydroxychloroquine for COVID–19 11 12 5 Wei Tang* Confidential:Email: [email protected], Forjob title: Reviewchest physician; associate Only professor 13 14 6 Zhujun Cao* Email: [email protected], job title: infectious diseases physician 15 16 7 Mingfeng Han* Email: [email protected], job title: chest physician 17 8 Zhengyan Wang* Email: [email protected], job title: chest physician 18 19 9 Junwen Chen Email: [email protected], job title: chest physician 20 21 10 Wenjin Sun Email: [email protected], job title: infectious diseases physician 22 23 11 Yaojie Wu Email: [email protected], job title: cardiovascular physician 24 25 12 Wei Xiao Email: [email protected], job title: chest physician 26 27 13 Shengyong Liu Email: [email protected], job title: infectious diseases physician 28 29 14 Erzhen Chen Email: [email protected], job title: professor 30 31 15 Wei Chen Email: [email protected], job title: chest physician 32 33 16 Xiongbiao Wang Email: [email protected], job title: chest physician 34 35 17 Jiuyong Yang Email: [email protected], job title: chest physician 36 18 Jun Lin Email: [email protected], job title: gastrointestinal physician 37 38 19 Qingxia Zhao E–mail: [email protected], job title: infectious diseases physician 39 40 20 Youqin Yan E–mail: [email protected], job title: infectious diseases physician 41 42 21 Zhibin Xie Email: [email protected], job title: chest physician 43 44 22 Dan Li Email: [email protected], job title: chest physician 45 46 23 Yaofeng Yang Email: [email protected], job title: chest physician 47 48 24 Leshan Liu E–mail: [email protected], job title: associate research fellow 49 50 25 Jieming Qu† Email: [email protected], job title: chest physician; professor 51 † 52 26 Guang Ning Email: [email protected], job title: endocrinology physician; professor 53 † 54 27 Guochao Shi Email: [email protected], job title: chest physician; professor 55 † 56 28 Qing Xie E–mail: [email protected], job title: professor 57 29 *Contributed equally 58 59 30 †Joint corresponding authors 60 1 https://mc.manuscriptcentral.com/bmj Page 3 of 39 BMJ 1 2 3 1 Affiliations: 4 5 6 2 1. Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong 7 8 3 University School of Medicine, Shanghai, China (W Tang, W Chen, J Qu, G Shi) 9 10 11 4 2. Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, 12 Confidential: For Review Only 13 14 5 China (W Tang, W Chen, J Qu, G Shi) 15 16 6 3. Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of 17 18 19 7 Medicine, Shanghai, China (Z Cao, Q Xie) 20 21 22 8 4. Department of Respiratory Medicine. No.2 people's hospital of Fuyang city, Fuyang, Anhui, 23 24 25 9 China (M Han) 26 27 10 5. Department of Respiratory Medicine, Suizhou Hospital, Hubei University of Medicine, Suizhou, 28 29 30 11 Hubei, China (Z Wang) 31 32 33 12 6. Department of Respiratory and Critical Care Medicine, Xiangyang No.1 People's Hospital, Hubei 34 35 13 University of Medicine, Xiangyang, Hubei, China (J Chen) 36 37 38 14 7. Department of Infectious Diseases, Central Hospital of Ezhou, Ezhou, Hubei, China (W Sun) 39 40 41 15 8. Department of Cardiovascular Medicine, Yunmeng people's hospital, Xiaogan, Hubei, China (Y 42 43 44 16 Wu) 45 46 17 9. Department of Respiratory Medicine, The First People's Hospital of Jingzhou City, Jingzhou, 47 48 49 18 Hubei, China (W Xiao) 50 51 52 19 10. Department of Infectious Diseases, Xiaogan hospital affiliated to Wuhan university of science 53 54 20 and technology, Xiaogan, Hubei, China (S Liu) 55 56 57 21 11. Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of 58 59 60 22 Medicine, Shanghai, China (E Chen) 2 https://mc.manuscriptcentral.com/bmj BMJ Page 4 of 39 1 2 3 1 12. Department of Respiratory Medicine, Putuo Hospital, Shanghai University of Traditional 4 5 6 2 Chinese Medicine, Shanghai, China (X Wang) 7 8 3 13. Department of Respiratory Medicine, Hubei Space Hospital of Xiaogan, Xiaogan, Hubei, China 9 10 11 4 (J Yang) 12 Confidential: For Review Only 13 14 5 14. Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 15 16 6 China (J Lin) 17 18 19 7 15. Department of Infectious Disease, The Sixth People’s Hospital of Zhengzhou, Zhengzhou, 20 21 22 8 Henan, China (Q Zhao) 23 24 25 9 16. Department of Infectious Disease, Wuhan No.7 Hospital, Wuhan, Hubei, China (Y Yan) 26 27 10 17. Departments of Respiratory Medicine, Xiaogan Hospital Affiliated to Wuhan University of 28 29 30 11 Science and Technology, Xiaogan, Hubei, China (Z Xie) 31 32 33 12 18. Department of Respiratory Medicine, The Third People’s Hospital of Yichang, Yichang, Hubei, 34 35 13 China (D Li) 36 37 38 14 19. Department of Respiratory Medicine, Xiao Gan First People’s Hospital, Xiaogan, Hubei 39 40 41 15 province, China (Y Yang) 42 43 44 16 20. Clinical Research Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 45 46 17 Shanghai, China (L Liu) 47 48 49 18 21. Shanghai National Research Centre for Endocrine and Metabolic Diseases, State Key Laboratory 50 51 52 19 of Medical Genomics, Shanghai Institute for Endocrine and Metabolic Diseases, Ruijin Hospital, 53 54 20 Shanghai Jiao Tong University School of Medicine, Shanghai, China (G Nin) 55 56 57 58 59 60 3 https://mc.manuscriptcentral.com/bmj Page 5 of 39 BMJ 1 2 3 1 Correspondence: 4 5 6 2 Qing Xie, 7 8 3 Department of Infectious Disease, Ruijin Hospital, 9 10 11 4 Shanghai Jiao Tong University School of Medicine, 12 Confidential: For Review Only 13 14 5 197 Ruijin 2nd Road, Shanghai, 200025, China 15 16 6 Email: [email protected] 17 18 19 7 Author contributions: 20 21 22 8 WT, ZC, MH and ZW contributed equally to this paper and share joint first authorship. QX, GS, GN, 23 24 25 9 and JQ contributed equally to this paper and share joint corresponding authorship. QX and GS were 26 27 10 co–chief investigators of this trial and act as guarantors of the study in its entirety.
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