Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.
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DOI：
10.1093/ofid/ofaa500
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发表时间：
2020-11
影响因子：
4.2
通讯作者：
Rajasingham R
中科院分区：
文献类型：
--
作者：
Lofgren SM;Nicol MR;Bangdiwala AS;Pastick KA;Okafor EC;Skipper CP;Pullen MF;Engen NW;Abassi M;Williams DA;Nascene AA;Axelrod ML;Lother SA;MacKenzie LJ;Drobot G;Marten N;Cheng MP;Zarychanski R;Schwartz IS;Silverman M;Chagla Z;Kelly LE;McDonald EG;Lee TC;Hullsiek KH;Boulware DR;Rajasingham R
在2019冠状病毒病（COVID-19）住院患者中使用羟氯喹，特别是与阿奇霉素联合使用，引起了安全问题。在这里，我们报告了3个门诊随机临床试验的安全性数据。我们进行了3项随机、双盲、安慰剂对照试验，采用基于互联网的设计，研究羟氯喹作为COVID-19暴露前预防、暴露后预防和早期治疗的效果。我们排除了羟氯喹禁忌症患者。我们收集了副作用和严重的不良事件。我们报告了我们的发现的描述性分析。我们招募了2795名参与者。研究参与者的年龄中位数（四分位数范围）为40岁（34-49岁），59%（1633/2767）报告无慢性疾病。总的来说，2544名（91%）参与者报告了副作用数据，748名（29%）报告了至少一种药物副作用。与安慰剂组的19%相比，羟氯喹组的副作用发生率为每日一次的40%，每周两次的36%，每周一次的31%。最常见的副作用是胃部不适或恶心（每日1次组为25%，每周2次组为19%，每周1次组为18%，安慰剂组为11%），其次是腹泻、呕吐或腹痛（每日1次组为23%，每周2次组为17%，每周一次组为13%，安慰剂组为7%）。2人因房性心律失常住院，1人服用安慰剂，1人服用每周两次的羟氯喹。没有发生突然死亡。来自3个门诊COVID-19试验的数据表明，使用羟氯喹的胃肠道副作用很常见，但很轻微，而严重的副作用很少见。没有发生与羟氯喹有关的死亡。在健康门诊患者队列中进行的随机临床试验可以安全地调查羟氯喹对COVID-19是否有效。NCT04308668用于暴露后预防和早期治疗试验；NCT04328467用于暴露前预防试验。
Use of hydroxychloroquine in hospitalized patients with coronavirus disease 2019 (COVID-19), especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from 3 outpatient randomized clinical trials. We conducted 3 randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, postexposure prophylaxis, and early treatment for COVID-19 using an internet-based design. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings. We enrolled 2795 participants. The median age of research participants (interquartile range) was 40 (34–49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2544 (91%) participants reported side effect data, and 748 (29%) reported at least 1 medication side effect. Side effects were reported in 40% with once-daily, 36% with twice-weekly, 31% with once-weekly hydroxychloroquine, compared with 19% with placebo. The most common side effects were upset stomach or nausea (25% with once-daily, 19% with twice-weekly, and 18% with once-weekly hydroxychloroquine, vs 11% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for once-daily, 17% twice-weekly, and 13% once-weekly hydroxychloroquine, vs 7% for placebo). Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly hydroxychloroquine. No sudden deaths occurred. Data from 3 outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials, in cohorts of healthy outpatients, can safely investigate whether hydroxychloroquine is efficacious for COVID-19. NCT04308668 for postexposure prophylaxis and early treatment trials; NCT04328467 for pre-exposure prophylaxis trial.
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影响因子：
158.5
作者：
Boulware, David R.;Pullen, Matthew F.;Hullsiek, Kathy H.
通讯作者：
Hullsiek, Kathy H.
影响因子：
39.2
作者：
Skipper, Caleb P.;Pastick, Katelyn A.;Boulware, David R.
通讯作者：
Boulware, David R.
影响因子：
--
作者：
Munster, T;Gibbs, JP;Furst, DE
通讯作者：
Furst, DE
影响因子：
6.7
作者：
Al-Kofahi, Mahmoud;Jacobson, Pamala;Nicol, Melanie R.
通讯作者：
Nicol, Melanie R.
2019年严重冠状病毒病患者（COVID-19）患者的电解质失衡。
影响因子：
2.2
作者：
Lippi G;South AM;Henry BM
通讯作者：
Henry BM