Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients.
Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients.
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DOI：
10.1093/ofid/ofaa446
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发表时间：
2020-10
影响因子：
4.2
通讯作者：
Mulligan MJ
中科院分区：
文献类型：
--
作者：
Ulrich RJ;Troxel AB;Carmody E;Eapen J;Bäcker M;DeHovitz JA;Prasad PJ;Li Y;Delgado C;Jrada M;Robbins GA;Henderson B;Hrycko A;Delpachitra D;Raabe V;Austrian JS;Dubrovskaya Y;Mulligan MJ
迫切需要有效的治疗方法来对抗2019冠状病毒（COVID-19）。羟氯喹（Hydroxychloroquine， HCQ）在体外具有抗严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）的抗病毒活性，但HCQ治疗COVID-19的临床疗效尚不清楚。需要随机对照试验来确定HCQ治疗COVID-19住院患者的安全性和有效性。我们在实验室确诊的COVID-19住院患者中开展了一项多中心、双盲、随机临床试验。受试者按1:1的比例随机分为HCQ组或安慰剂组，为期5天，随访30天。主要疗效终点是第14天严重疾病进展复合终点（死亡、重症监护病房入住、机械通气、体外膜氧合和/或使用血管加压药）。共有128名患者被纳入意向治疗分析。基线人口统计学、临床和实验室特征在HCQ组（n = 67）和安慰剂组（n = 61）之间相似。在第14天，11名（16.4%）HCQ组受试者和6名（9.8%）安慰剂组受试者达到了严重疾病进展终点，但这没有达到统计学意义（P = 0.350）。HCQ与安慰剂在COVID-19临床评分、无氧天数、SARS-CoV-2清除率或不良事件方面无显著差异。HCQ与平均校正QT间期轻微增加、d -二聚体增加以及住院时间增加的趋势有关。在COVID-19住院患者中，我们的数据表明HCQ不能预防严重结局或提高临床评分。然而，我们的结论受到相对较小的样本量的限制，需要更大规模的随机对照试验或合并分析。COVID-19住院患者急需治疗。在这项多中心、双盲、随机试验中，5天羟氯喹（N=67）与安慰剂（N=61）相比没有益处。羟氯喹增加qT间期、d -二聚体，并有延长住院时间的趋势。需要更大规模的试验。
Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19. We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14. A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (P = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay. In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed. Treatments for patients hospitalized with COVID-19 are urgently needed. In this multicenter, double-blind, randomized trial, five days of hydroxychloroquine (N=67) did not suggest benefit compared to placebo (N=61). Hydroxychloroquine increased qT interval, D-dimer, and trended towards an increased length of stay. Larger trials are needed.
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影响因子：
158.5
作者：
Cavalcanti, A. B.;Zampieri, F. G.;Berwanger, O.
通讯作者：
Berwanger, O.
DOI：
10.1016/j.ijantimicag.2020.105949
发表时间：
2020-07-01
影响因子：
10.8
作者：
Gautret, Philippe;Lagier, Jean-Christophe;Raoult, Didier
通讯作者：
Raoult, Didier
中国武汉市 138 例 2019 新型冠状病毒感染肺炎住院患者的临床特征。
影响因子：
120.7
作者：
Wang, Dawei;Hu, Bo;Peng, Zhiyong
通讯作者：
Peng, Zhiyong
影响因子：
12
作者：
Lagier, Jean-Christophe;Million, Matthieu;Raoult, Didier
通讯作者：
Raoult, Didier
影响因子：
120.7
作者：
Rosenberg, Eli S.;Dufort, Elizabeth M.;Zucker, Howard A.
通讯作者：
Zucker, Howard A.