A pilot study of hydroxychloroquine in treatment of patients with common coronavirus disease-19 (COVID-19)

Chen et al., J. Zhejiang University (Med Sci), doi:10.3785/j.issn.1008-9292.2020.03.03, NCT04261517, Mar 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 121 treatments. c19hcq.org

30 moderate hospitalized cases, all recovered. Time to RNA negative comparable. Less frequent radiological progression with HCQ but not statistically significant. One HCQ patient developed to a severe case. Treatment group 4 years older and with higher incidence of hypertension.

Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture. Porter et al. show that viral load early in infection was correlated with infectious virus, but viral load late in infection could be high even with low or undetectable infectious virus. Assessing viral load later in infection may underestimate reductions in infectious virus with treatment.

Standard of Care (SOC) for COVID-19 in the study country, China, is poor with low average efficacy for approved treatments2.

Important missing comments or errors? Let us know.

risk of radiological progression, 29.0% lower, RR 0.71, p = 0.57, treatment 5 of 15 (33.3%), control 7 of 15 (46.7%), NNT 7.5.

risk of viral+ at day 7, 100% higher, RR 2.00, p = 1.00, treatment 2 of 15 (13.3%), control 1 of 15 (6.7%).

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

1. Porter et al., The ratio between SARS-CoV-2 RNA viral load and culturable viral titer differs depending on stage of infection, medRxiv, doi:10.1101/2023.07.06.23292300.medrxiv.org, doi.org.

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

Chen et al., 6 Mar 2020, Randomized Controlled Trial, China, peer-reviewed, 14 authors, study period 6 February, 2020 - 25 February, 2020, trial NCT04261517 (history).

This Paper HCQ All

Abstract: 浙江大学学报 ( 医学版 ) ２０２０年４月Ａｐｒｉｌ２０２０ｈｔｔｐ:∥ｗｗｗ. ｚｊｕｊｏｕｒｎａｌｓ. ｃｏｍ / ｍｅｄＤＯＩ:１０. ３７８５ / ｊ. ｉｓｓｎ. １００８￣９２９２. ２０２０. ０３. ０３ＪＯＵＲＮＡＬＯＦＺＨＥＪＩＡＮＧＵＮＩＶＥＲＳＩＴＹ ( ＭＥＤＩＣＡＬＳＣＩＥＮＣＥＳ) 􀅰原著􀅰 硫酸羟氯喹治疗２０１９冠状病毒病( ＣＯＶＩＤ￣１９) 普通型患者的初步研究陈军ꎬ刘丹萍ꎬ刘张丹丹ꎬ钱志平ꎬ李莉ꎬ刘萍ꎬ徐庆年ꎬ夏涛ꎬ沈银忠ꎬ卢洪洲露ꎬ凌云ꎬ黄丹ꎬ宋树丽ꎬ 上海市公共卫生临床中心感染与免疫科ꎬ 上海２０１５０８ [摘要] 目的:初步评价硫酸羟氯喹治疗２０１９冠状病毒病( ＣＯＶＩＤ￣１９) 普通型患者的疗效和安全性ꎮ 方法:收集２０２０年２月６至２５日在上海市公共卫生临床中心住院治疗的３０例ＣＯＶＩＤ￣１９普通型患者ꎮ 患者１∶ １随机分配到试验组和对照组ꎮ 对照组接受常规治疗ꎬ试验组在常规治疗的基础上口服硫酸羟氯喹(４００ｍｇꎬ １次 / ｄ) 治疗ꎬ疗程为５ｄꎮ 比较两组治疗第７天时咽拭子病毒核酸转阴率等指标ꎮ 研究获上海市公共卫生临床中心伦理委员会批准ꎬ并登记注册( ＮＣＴ０４２６１５１７) ꎮ 结果:在治疗过程中ꎬ试验组１例患者发展为重型ꎮ 入组后第７天ꎬ试验组中１３例 (８６. ７％ ) 和对照组中１４例(９３. ３％ ) 患者咽拭子病毒核酸检测为阴性( Ｐ > ０. ０５) ꎮ 在２周的访视期内ꎬ所有受试者的咽拭子核酸检测均转为阴性ꎬ其中试验组咽拭子核酸转阴时间为入院后第４ (１ꎬ９) 天ꎬ对照组为第２ (１ꎬ４) 天ꎬ差异无统计学意义 (Ｚ＝１. ２７ꎬＰ > ０. ０５) ꎮ 试验组在入院后第１(０ꎬ２)天体温恢复正常ꎬ对照组在入院后第１(０ꎬ３)天体温恢复正常ꎮ 影像学检查结果显示ꎬ试验组５例(３３. ３％ ) 和对照组７例(４６. ７％ ) 患者均在入院３ｄ后的复查中出现了进展ꎬ所有患者在随后的复查中均提示病灶好转ꎮ 试验组和对照组分别有４例(２６. ７％ ) 和３例(２０. ０％ ) 患者出现一过性的腹泻和肝功能异常等不良反应ꎬ两组不良反应发生率差异无统计学意义 ( Ｐ > ０. ０５) ꎮ 结论:目前ＣＯＶＩＤ￣１９普通型患者预后较好ꎬ以病毒转阴率、重症化率为主要终点的研究难以对药物的疗效进行判断ꎮ 开展后续的研究需要确定更合适的人群和终点事件ꎬ并充分考虑样本量等试验的可行性问题ꎮ [关键词] ２０１９冠状病毒病ꎻ 严重急性呼吸综合征冠状病毒２ꎻ 新型冠状病毒肺炎ꎻ 羟氯喹ꎻ 治疗结果ꎻ 安全性ꎻ 随机对照试验 [ 中图分类号] Ｒ５１２. ９９ [ 文献标志码] Ａ收稿日期:２０２０￣０２￣２９接受日期:２０２０￣０３￣０３在线优先出版日期:２０２０￣０３￣０６基金项目: 上海市科学技术委员会应急科技攻关专项 ( ２０４３１９００１０３ ) ꎻ 复旦大学一流大学和一流学科建设项目 ( ＩＤＦ１６２００５) ꎻ浙江大学新型冠状病毒(２０１９￣ｎＣｏＶ) 肺炎应急科研专项(２０２０ＸＧＺＸ０３０) ꎻ上海市公共卫生临床中心新型冠状病毒“２０１９￣ｎＣｏＶ” 科研攻关院内专项(２０２０ＹＪＫＹ０１) ꎻ上海市重点专科传染病项目( ｓｈｓｌｃｚｄｚｋ０１１０２) ꎻ上海市“ 医苑新星” 医学人才项目(２０１９￣７２) 第一作者:陈军(１９８４—) ꎬ男ꎬ博士ꎬ副主任医师ꎬ主要从事感染性疾病的诊治和发病机制研究ꎻＥ￣ｍａｉｌ: ｑｔｃｈｅｎｊｕｎ＠１６３. ｃｏｍꎻ ｈｔｔｐｓ: / / ｏｒｃｉｄ. ｏｒｇ / ００００￣０００２￣３８５０￣４８７５通信作者:卢洪洲( １９６６—) ꎬ 男ꎬ 博士ꎬ 教授ꎬ 主任医师ꎬ 博士生导师ꎬ 主要从事感染性疾病的诊治和发病机制研究ꎻ Ｅ￣ｍａｉｌ: ｌｕｈｏｎｇｚｈｏｕ＠ｆｕｄａｎ. ｅｄｕ. ｃｎꎻ ｈｔｔｐｓ: / / ｏｒｃｉｄ. ｏｒｇ / ００００￣０００２￣８３０８￣５５３４浙江大学学报( 医学版) ＪｏｕｒｎａｌｏｆＺｈｅｊｉａｎｇＵｎｉｖｅｒｓｉｔｙ ( ＭｅｄｉｃａｌＳｃｉｅｎｃｅｓ) 􀅰 ２１６􀅰 ＡｐｉｌｏｔｓｔｕｄｙｏｆｈｙｄｒｏｘｙｃｈｌｏｒｏｑｕｉｎｅｉｎｔｒｅａｔｍｅｎｔｏｆｐａｔｉｅｎｔｓｗｉｔｈｍｏｄｅｒａｔｅＣＯＶＩＤ￣１９ＣＨＥＮＪｕｎꎬ ＬＩＵＤａｎｐｉｎｇꎬ ＬＩＵＬｉꎬ ＬＩＵＰｉｎｇꎬ ＸＵＱｉｎｇｎｉａｎꎬ ＸＩＡＬｕꎬ ＬＩＮＧＹｕｎꎬ ＨＵＡＮＧＤａｎꎬ ＳＯＮＧＳｈｕｌｉꎬ ＺＨＡＮＧＤａｎｄａｎꎬ ＱＩＡＮＺｈｉｐｉｎｇꎬ ＬＩＴａｏꎬ ＳＨＥＮＹｉｎｚｈｏｎｇꎬ ＬＵＨｏｎｇｚｈｏｕ ( ＤｅｐａｒｔｍｅｎｔｏｆＩｎｆｅｃｔｉｏｎａｎｄＩｍｍｕｎｉｔｙꎬ ＳｈａｎｇｈａｉＰｕｂｌｉｃＨｅａｌｔｈＣｌｉｎｉｃａｌＣｅｎｔｅｒꎬ ＦｕｄａｎＵｎｉｖｅｒｓｉｔｙꎬ Ｓｈａｎｇｈａｉ２０１５０８ꎬ Ｃｈｉｎａ) Ｃｏｒｒｅｓｐｏｎｄｉｎｇａｕｔｈｏｒ: ＬＵＨｏｎｇｚｈｏｕꎬ Ｅ￣ｍａｉｌ: ｌｕｈｏｎｇｚｈｏｕ＠ｆｕｄａｎ. ｅｄｕ. ｃｎꎬ ｈｔｔｐｓ: / / ｏｒｃｉｄ. ｏｒｇ / ００００￣０００２￣８３０８￣５５３４ [ Ａｂｓｔｒａｃｔ] Ｏｂｊｅｃｔｉｖｅ: Ｔｏｅｖａｌｕａｔｅｔｈｅｅｆｆｉｃａｃｙａｎｄｓａｆｅｔｙｏｆｈｙｄｒｏｘｙｃｈｌｏｒｏｑｕｉｎｅ ( ＨＣＱ) ｉｎｔｈｅｔｒｅａｔｍｅｎｔｏｆｐａｔｉｅｎｔｓｗｉｔｈｍｏｄｅｒａｔｅｃｏｒｏｎａｖｉｒｕｓｄｉｓｅａｓｅ２０１９ ( ＣＯＶＩＤ￣１９) . Ｍｅｔｈｏｄｓ: Ｗｅｐｒｏｓｐｅｃｔｉｖｅｌｙｅｎｒｏｌｌｅｄ３０ｔｒｅａｔｍｅｎｔ￣ｎａïｖｅｐａｔｉｅｎｔｓｗｉｔｈｃｏｎｆｉｒｍｅｄＣＯＶＩＤ￣１９ａｆｔｅｒｉｎｆｏｒｍｅｄｃｏｎｓｅｎｔａｔＳｈａｎｇｈａｉＰｕｂｌｉｃＨｅａｌｔｈＣｌｉｎｉｃａｌＣｅｎｔｅｒ. Ｔｈｅｐａｔｉｅｎｔｓｗｅｒｅｒａｎｄｏｍｉｚｅｄ１ ∶ １ｔｏＨＣＱｇｒｏｕｐａｎｄｔｈｅｃｏｎｔｒｏｌｇｒｏｕｐ. ＰａｔｉｅｎｔｓｉｎＨＣＱｇｒｏｕｐｗｅｒｅｇｉｖｅｎＨＣＱ４００ｍｇｐｅｒｄａｙｆｏｒ５ｄａｙｓｐｌｕｓｃｏｎｖｅｎｔｉｏｎａｌｔｒｅａｔｍｅｎｔｓꎬ ｗｈｉｌｅｔｈｏｓｅｉｎｔｈｅｃｏｎｔｒｏｌｇｒｏｕｐｗｅｒｅｇｉｖｅｎｃｏｎｖｅｎｔｉｏｎａｌｔｒｅａｔｍｅｎｔｏｎｌｙ. ＴｈｅｐｒｉｍａｒｙｅｎｄｐｏｉｎｔｗａｓｎｅｇａｔｉｖｅｃｏｎｖｅｒｓｉｏｎｒａｔｅｏｆＳＡＲＳ￣ＣｏＶ￣２ｎｕｃｌｅｉｃａｃｉｄｉｎｒｅｓｐｉｒａｔｏｒｙｐｈａｒｙｎｇｅａｌｓｗａｂｏｎｄａｙｓ７ａｆｔｅｒｒａｎｄｏｍｉｚａｔｉｏｎ. ＴｈｉｓｓｔｕｄｙｈａｓｂｅｅｎａｐｐｒｏｖｅｄｂｙｔｈｅＥｔｈｉｃｓＣｏｍｍｉｔｔｅｅｏｆＳｈａｎｇｈａｉＰｕｂｌｉｃＨｅａｌｔｈＣｌｉｎｉｃａｌＣｅｎｔｅｒａｎｄｒｅｇｉｓｔｅｒｅｄｏｎｌｉｎｅ ( ＮＣＴ０４２６１５１７ ) . Ｒｅｓｕｌｔｓ: ＯｎｅｐａｔｉｅｎｔｉｎＨＣＱｇｒｏｕｐｄｅｖｅｌｏｐｅｄｔｏｓｅｖｅｒｅｄｕｒｉｎｇｔｈｅｔｒｅａｔｍｅｎｔ. Ｏｎｄａｙ７ꎬ ｎｕｃｌｅｉｃａｃｉｄｏｆｔｈｒｏａｔｓｗａｂｓｗａｓｎｅｇａｔｉｖｅｉｎ１３ (８６. ７％ ) ｃａｓｅｓｉｎｔｈｅＨＣＱｇｒｏｕｐａｎｄ１４ (９３. ３％ ) ｃａｓｅｓｉｎｔｈｅｃｏｎｔｒｏｌｇｒｏｕｐ ( Ｐ > ０. ０５) . Ｔｈｅｍｅｄｉａｎｄｕｒａｔｉｏｎ..

Late treatment
is less effective

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