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      Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial

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          Abstract

          Objective

          To assess the efficacy and safety of hydroxychloroquine plus standard of care compared with standard of care alone in adults with coronavirus disease 2019 (covid-19).

          Design

          Multicentre, open label, randomised controlled trial.

          Setting

          16 government designated covid-19 treatment centres in China, 11 to 29 February 2020.

          Participants

          150 patients admitted to hospital with laboratory confirmed covid-19 were included in the intention to treat analysis (75 patients assigned to hydroxychloroquine plus standard of care, 75 to standard of care alone).

          Interventions

          Hydroxychloroquine administrated at a loading dose of 1200 mg daily for three days followed by a maintenance dose of 800 mg daily (total treatment duration: two or three weeks for patients with mild to moderate or severe disease, respectively).

          Main outcome measure

          Negative conversion of severe acute respiratory syndrome coronavirus 2 by 28 days, analysed according to the intention to treat principle. Adverse events were analysed in the safety population in which hydroxychloroquine recipients were participants who received at least one dose of hydroxychloroquine and hydroxychloroquine non-recipients were those managed with standard of care alone.

          Results

          Of 150 patients, 148 had mild to moderate disease and two had severe disease. The mean duration from symptom onset to randomisation was 16.6 (SD 10.5; range 3-41) days. A total of 109 (73%) patients (56 standard of care; 53 standard of care plus hydroxychloroquine) had negative conversion well before 28 days, and the remaining 41 (27%) patients (19 standard of care; 22 standard of care plus hydroxychloroquine) were censored as they did not reach negative conversion of virus. The probability of negative conversion by 28 days in the standard of care plus hydroxychloroquine group was 85.4% (95% confidence interval 73.8% to 93.8%), similar to that in the standard of care group (81.3%, 71.2% to 89.6%). The difference between groups was 4.1% (95% confidence interval –10.3% to 18.5%). In the safety population, adverse events were recorded in 7/80 (9%) hydroxychloroquine non-recipients and in 21/70 (30%) hydroxychloroquine recipients. The most common adverse event in the hydroxychloroquine recipients was diarrhoea, reported in 7/70 (10%) patients. Two hydroxychloroquine recipients reported serious adverse events.

          Conclusions

          Administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone in patients admitted to hospital with mainly persistent mild to moderate covid-19. Adverse events were higher in hydroxychloroquine recipients than in non-recipients.

          Trial registration

          ChiCTR2000029868.

          Related collections

          Most cited references 7

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          Seasonal influenza in adults and children--diagnosis, treatment, chemoprophylaxis, and institutional outbreak management: clinical practice guidelines of the Infectious Diseases Society of America.

          Guidelines for the treatment of persons with influenza virus infection were prepared by an Expert Panel of the Infectious Diseases Society of America. The evidence-based guidelines encompass diagnostic issues, treatment and chemoprophylaxis with antiviral medications, and issues related to institutional outbreak management for seasonal (interpandemic) influenza. They are intended for use by physicians in all medical specialties with direct patient care, because influenza virus infection is common in communities during influenza season and may be encountered by practitioners caring for a wide variety of patients.
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            Oral erythromycin and the risk of sudden death from cardiac causes.

            Oral erythromycin prolongs cardiac repolarization and is associated with case reports of torsades de pointes. Because erythromycin is extensively metabolized by cytochrome P-450 3A (CYP3A) isozymes, commonly used medications that inhibit the effects of CYP3A may increase plasma erythromycin concentrations, thereby increasing the risk of ventricular arrhythmias and sudden death. We studied the association between the use of erythromycin and the risk of sudden death from cardiac causes and whether this risk was increased with the concurrent use of strong inhibitors of CYP3A. We studied a previously identified Tennessee Medicaid cohort that included 1,249,943 person-years of follow-up and 1476 cases of confirmed sudden death from cardiac causes. The CYP3A inhibitors used in the study were nitroimidazole antifungal agents, diltiazem, verapamil, and troleandomycin; each doubles, at least, the area under the time-concentration curve for a CYP3A substrate. Amoxicillin, an antimicrobial agent with similar indications but which does not prolong cardiac repolarization, and former use of erythromycin also were studied, to assess possible confounding by indication. The multivariate adjusted rate of sudden death from cardiac causes among patients currently using erythromycin was twice as high (incidence-rate ratio, 2.01; 95 percent confidence interval, 1.08 to 3.75; P=0.03) as that among those who had not used any of the study antibiotic medications. There was no significant increase in the risk of sudden death among former users of erythromycin (incidence-rate ratio, 0.89; 95 percent confidence interval, 0.72 to 1.09; P=0.26) or among those who were currently using amoxicillin (incidence-rate ratio, 1.18; 95 percent confidence interval, 0.59 to 2.36; P=0.65). The adjusted rate of sudden death from cardiac causes was five times as high (incidence-rate ratio, 5.35; 95 percent confidence interval, 1.72 to 16.64; P=0.004) among those who concurrently used CYP3A inhibitors and erythromycin as that among those who had used neither CYP3A inhibitors nor any of the study antibiotic medications. In contrast, there was no increase in the risk of sudden death among those who concurrently used amoxicillin and CYP3A inhibitors or those currently using any of the study antibiotic medications who had formerly used CYP3A inhibitors. The concurrent use of erythromycin and strong inhibitors of CYP3A should be avoided. Copyright 2004 Massachusetts Medical Society
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              Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome: Current Therapeutic Options and Potential Targets for Novel Therapies

              No specific antivirals are currently available for two emerging infectious diseases, Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). A literature search covering pathogenesis, clinical features and therapeutics, clinically developed drugs for repurposing and novel drug targets was performed. This review presents current knowledge on the epidemiology, pathogenesis and clinical features of the SARS and MERS coronaviruses. The rationale for and outcomes with treatments used for SARS and MERS is discussed. The main focus of the review is on drug development and the potential that drugs approved for other indications provide for repurposing. The drugs we discuss belong to a wide range of different drug classes, such as cancer therapeutics, antipsychotics, and antimalarials. In addition to their activity against MERS and SARS coronaviruses, many of these approved drugs have broad-spectrum potential and have already been in clinical use for treating other viral infections. A wealth of knowledge is available for these drugs. However, the information in this review is not meant to guide clinical decisions, and any therapeutic described here should only be used in context of a clinical trial. Potential targets for novel antivirals and antibodies are discussed as well as lessons learned from treatment development for other RNA viruses. The article concludes with a discussion of the gaps in our knowledge and areas for future research on emerging coronaviruses.
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                Author and article information

                Contributors
                Role: associate professor
                Role: infectious diseases physician
                Role: chest physician
                Role: chest physician
                Role: chest physician
                Role: infectious diseases physician
                Role: cardiovascular physician
                Role: chest physician
                Role: infectious diseases physician
                Role: professor
                Role: chest physician
                Role: chest physician
                Role: chest physician
                Role: gastrointestinal physician
                Role: infectious diseases physician
                Role: infectious diseases physician
                Role: chest physician
                Role: chest physician
                Role: chest physician
                Role: associate research fellow in statistics
                Role: chest physician and professor
                Role: endocrinology physician and professor
                Role: chest physician and professor
                Role: professor
                Journal
                BMJ
                BMJ
                BMJ-UK
                bmj
                The BMJ
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2020
                14 May 2020
                : 369
                Affiliations
                [1 ]Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
                [2 ]Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
                [3 ]Department of Infectious Disease, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
                [4 ]Department of Respiratory Medicine, No 2 People’s Hospital of Fuyang City, Fuyang, Anhui, China
                [5 ]Department of Respiratory Medicine, Suizhou Hospital, Hubei University of Medicine, Suizhou, Hubei, China
                [6 ]Department of Respiratory and Critical Care Medicine, Xiangyang No 1 People’s Hospital, Hubei University of Medicine, Xiangyang, Hubei, China
                [7 ]Department of Infectious Diseases, Central Hospital of Ezhou, Ezhou, Hubei, China
                [8 ]Department of Cardiovascular Medicine, Yunmeng People’s Hospital, Xiaogan, Hubei, China
                [9 ]Department of Respiratory Medicine, First People’s Hospital of Jingzhou City, Jingzhou, Hubei, China
                [10 ]Department of Infectious Diseases, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China
                [11 ]Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
                [12 ]Department of Respiratory Medicine, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
                [13 ]Department of Respiratory Medicine, Hubei Space Hospital of Xiaogan, Xiaogan, Hubei, China
                [14 ]Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
                [15 ]Department of Infectious Disease, The Sixth People’s Hospital of Zhengzhou, Zhengzhou, Henan, China
                [16 ]Department of Infectious Disease, Wuhan No 7 Hospital, Wuhan, Hubei, China
                [17 ]Departments of Respiratory Medicine, Xiaogan Hospital Affiliated to Wuhan University of Science and Technology, Xiaogan, Hubei, China
                [18 ]Department of Respiratory Medicine, The Third People’s Hospital of Yichang, Yichang, Hubei, China
                [19 ]Department of Respiratory Medicine, Xiao Gan First People’s Hospital, Xiaogan, Hubei Province, China
                [20 ]Clinical Research Centre, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
                [21 ]Shanghai National Research Centre for Endocrine and Metabolic Diseases, State Key Laboratory of Medical Genomics, Shanghai Institute for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
                Author notes
                Correspondence to: Q Xie xieqingrjh@ 123456163.com
                Article
                weit056844
                10.1136/bmj.m1849
                7221473
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

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