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
Radiological progress.. 29% improvement lower risk ← → higher risk Viral+ at day 7 -100% HCQ for COVID-19  Chen et al.  LATE TREATMENT RCT Is late treatment with HCQ beneficial for COVID-19? RCT 30 patients in China (February - February 2020) Lower progression with HCQ (not stat. sig., p=0.57) c19early.org Chen et al., J. Zhejiang University, Mar 2020 0 0.5 1 1.5 2+ RR
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 424 studies, used in 59 countries.
Lower risk for mortality, hospitalization, progression, recovery, cases, and viral clearance.
No treatment is 100% effective. Protocols combine treatments.
6,300+ studies for 210+ treatments. c19early.org
Meta Analysis
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 average with moderate 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
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).
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org December 2025 China United Kingdom Russia USA Sudan Angola Colombia Kenya Mozambique Pakistan Argentina Vietnam Peru Philippines Spain Brazil Italy France Japan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland India DR Congo Madagascar Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Bosnia-Herzegovina Côte d'Ivoire Eritrea Bulgaria Greece Slovakia Singapore Iceland New Zealand Czechia Mongolia Israel Trinidad and Tobago Hong Kong North Macedonia Belarus Qatar Panama Serbia CAR China favored low-cost treatments.The average efficacy of treatments was moderate.Low-cost treatments improve early treatment, andprovide complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org December 2025 China United Kingdom Russia USA Sudan Angola Colombia Kenya Mozambique Pakistan Argentina Vietnam Peru Philippines Spain Brazil Italy France Japan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland India DR Congo Madagascar Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Côte d'Ivoire Eritrea Togo Bulgaria Greece Slovakia Singapore New Zealand Malawi Czechia Mongolia Israel Trinidad and Tobago North Macedonia Belarus Qatar Panama Serbia Syria China favored low-cost treatments.The average efficacy was moderate.Low-cost protocols improve early treatment,and add complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Abstract: 浙 江 大 学 学 报 ( 医 学 版 ) ２０２０ 年 ４ 月 Ａｐｒｉｌ ２０２０ ｈｔｔｐ:∥ｗｗｗ. ｚｊｕｊｏｕｒｎａｌｓ. ｃｏｍ / ｍｅｄ ＤＯＩ:１０. ３７８５ / ｊ. ｉｓｓｎ. １００８￣９２９２. ２０２０. ０３. ０３ ＪＯＵＲＮＡＬ ＯＦ ＺＨＥＪＩＡＮＧ ＵＮＩＶＥＲＳＩＴＹ ( ＭＥＤＩＣＡＬ ＳＣＩＥＮＣＥＳ) 􀅰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(４００ ｍｇꎬ １ 次 / ｄ) 治疗ꎬ疗程为 ５ ｄꎮ 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 ３ ｄ 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) Ｊｏｕｒｎａｌ ｏｆ Ｚｈｅｊｉａｎｇ Ｕｎｉｖｅｒｓｉｔｙ ( Ｍｅｄｉｃａｌ Ｓｃｉｅｎｃｅｓ) 􀅰 ２１６􀅰 Ａ ｐｉｌｏｔ ｓｔｕｄｙ ｏｆ ｈｙｄｒｏｘｙｃｈｌｏｒｏｑｕｉｎｅ ｉｎ ｔｒｅａｔｍｅｎｔ ｏｆ ｐａｔｉｅｎｔｓ ｗｉｔｈ ｍｏｄｅｒａｔｅ ＣＯＶＩＤ￣１９ ＣＨＥＮ Ｊｕｎꎬ ＬＩＵ Ｄａｎｐｉｎｇꎬ ＬＩＵ Ｌｉꎬ ＬＩＵ Ｐｉｎｇꎬ ＸＵ Ｑｉｎｇｎｉａｎꎬ ＸＩＡ Ｌｕꎬ ＬＩＮＧ Ｙｕｎꎬ ＨＵＡＮＧ Ｄａｎꎬ ＳＯＮＧ Ｓｈｕｌｉꎬ ＺＨＡＮＧ Ｄａｎｄａｎꎬ ＱＩＡＮ Ｚｈｉｐｉｎｇꎬ ＬＩ Ｔａｏꎬ ＳＨＥＮ Ｙｉｎｚｈｏｎｇꎬ ＬＵ Ｈｏｎｇｚｈｏｕ ( Ｄｅｐａｒｔｍｅｎｔ ｏｆ Ｉｎｆｅｃｔｉｏｎ ａｎｄ Ｉｍｍｕｎｉｔｙꎬ Ｓｈａｎｇｈａｉ Ｐｕｂｌｉｃ Ｈｅａｌｔｈ Ｃｌｉｎｉｃａｌ Ｃｅｎｔｅｒꎬ Ｆｕｄａｎ Ｕｎｉｖｅｒｓｉｔｙꎬ Ｓｈａｎｇｈａｉ ２０１５０８ꎬ Ｃｈｉｎａ) Ｃｏｒｒｅｓｐｏｎｄｉｎｇ ａｕｔｈｏｒ: ＬＵ Ｈｏｎｇｚｈｏｕꎬ Ｅ￣ｍａｉｌ: ｌｕｈｏｎｇｚｈｏｕ ＠ ｆｕｄａｎ. ｅｄｕ. ｃｎꎬ ｈｔｔｐｓ: / / ｏｒｃｉｄ. ｏｒｇ / ００００￣０００２￣８３０８￣５５３４ [ Ａｂｓｔｒａｃｔ] Ｏｂｊｅｃｔｉｖｅ: Ｔｏ ｅｖａｌｕａｔｅ ｔｈｅ ｅｆｆｉｃａｃｙ ａｎｄ ｓａｆｅｔｙ ｏｆ ｈｙｄｒｏｘｙｃｈｌｏｒｏｑｕｉｎｅ ( ＨＣＱ) ｉｎ ｔｈｅ ｔｒｅａｔｍｅｎｔ ｏｆ ｐａｔｉｅｎｔｓ ｗｉｔｈ ｍｏｄｅｒａｔｅ ｃｏｒｏｎａｖｉｒｕｓ ｄｉｓｅａｓｅ ２０１９ ( ＣＯＶＩＤ￣ １９) . Ｍｅｔｈｏｄｓ: Ｗｅ ｐｒｏｓｐｅｃｔｉｖｅｌｙ ｅｎｒｏｌｌｅｄ ３０ ｔｒｅａｔｍｅｎｔ￣ｎａïｖｅ ｐａｔｉｅｎｔｓ ｗｉｔｈ ｃｏｎｆｉｒｍｅｄ ＣＯＶＩＤ￣１９ ａｆｔｅｒ ｉｎｆｏｒｍｅｄ ｃｏｎｓｅｎｔ ａｔ Ｓｈａｎｇｈａｉ Ｐｕｂｌｉｃ Ｈｅａｌｔｈ Ｃｌｉｎｉｃａｌ Ｃｅｎｔｅｒ. Ｔｈｅ ｐａｔｉｅｎｔｓ ｗｅｒｅ ｒａｎｄｏｍｉｚｅｄ １ ∶ １ ｔｏ ＨＣＱ ｇｒｏｕｐ ａｎｄ ｔｈｅ ｃｏｎｔｒｏｌ ｇｒｏｕｐ. Ｐａｔｉｅｎｔｓ ｉｎ ＨＣＱ ｇｒｏｕｐ ｗｅｒｅ ｇｉｖｅｎ ＨＣＱ ４００ ｍｇ ｐｅｒ ｄａｙ ｆｏｒ ５ ｄａｙｓ ｐｌｕｓ ｃｏｎｖｅｎｔｉｏｎａｌ ｔｒｅａｔｍｅｎｔｓꎬ ｗｈｉｌｅ ｔｈｏｓｅ ｉｎ ｔｈｅ ｃｏｎｔｒｏｌ ｇｒｏｕｐ ｗｅｒｅ ｇｉｖｅｎ ｃｏｎｖｅｎｔｉｏｎａｌ ｔｒｅａｔｍｅｎｔ ｏｎｌｙ. Ｔｈｅ ｐｒｉｍａｒｙ ｅｎｄｐｏｉｎｔ ｗａｓ ｎｅｇａｔｉｖｅ ｃｏｎｖｅｒｓｉｏｎ ｒａｔｅ ｏｆ ＳＡＲＳ￣ＣｏＶ￣２ ｎｕｃｌｅｉｃ ａｃｉｄ ｉｎ ｒｅｓｐｉｒａｔｏｒｙ ｐｈａｒｙｎｇｅａｌ ｓｗａｂ ｏｎ ｄａｙｓ ７ ａｆｔｅｒ ｒａｎｄｏｍｉｚａｔｉｏｎ. Ｔｈｉｓ ｓｔｕｄｙ ｈａｓ ｂｅｅｎ ａｐｐｒｏｖｅｄ ｂｙ ｔｈｅ Ｅｔｈｉｃｓ Ｃｏｍｍｉｔｔｅｅ ｏｆ Ｓｈａｎｇｈａｉ Ｐｕｂｌｉｃ Ｈｅａｌｔｈ Ｃｌｉｎｉｃａｌ Ｃｅｎｔｅｒ ａｎｄ ｒｅｇｉｓｔｅｒｅｄ ｏｎｌｉｎｅ ( ＮＣＴ０４２６１５１７ ) . Ｒｅｓｕｌｔｓ: Ｏｎｅ ｐａｔｉｅｎｔ ｉｎ ＨＣＱ ｇｒｏｕｐ ｄｅｖｅｌｏｐｅｄ ｔｏ ｓｅｖｅｒｅ ｄｕｒｉｎｇ ｔｈｅ ｔｒｅａｔｍｅｎｔ. Ｏｎ ｄａｙ ７ꎬ ｎｕｃｌｅｉｃ ａｃｉｄ ｏｆ ｔｈｒｏａｔ ｓｗａｂｓ ｗａｓ ｎｅｇａｔｉｖｅ ｉｎ １３ (８６. ７％ ) ｃａｓｅｓ ｉｎ ｔｈｅ ＨＣＱ ｇｒｏｕｐ ａｎｄ １４ (９３. ３％ ) ｃａｓｅｓ ｉｎ ｔｈｅ ｃｏｎｔｒｏｌ ｇｒｏｕｐ ( Ｐ > ０. ０５) . Ｔｈｅ ｍｅｄｉａｎ ｄｕｒａｔｉｏｎ..
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 200,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.
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