NCT04652648已完成4 期
Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts
Bryn Mawr Hospital3 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年5月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- COVID-19 symptom development with positive PCR test
研究概览
简要总结
- organizing an entirely no in-person contact clinical trial is feasible during a 22 COVID-19 pandemic 23
- Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with the technology 25
- Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26 cardiotoxicity 27
- Additional study using this technique is warranted to look at reliability and cost-28 effectiveness
详细描述
Household members were contacted by telephone and provided consent forms via E-mail electronic signatures. Randomization was 2:1 to HCQ 200 mg BID or observation for 10 days with total follow-up of 14 days. COVID status was determined by home saliva PCR assay on days 1 and 14. Study drug was shipped to participants. Data of daily symptoms and 6-lead ECGs using a smartphone KardiaMobile® 6L application were collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •exposure to a COVID-19-infected individual in the same household within five days of diagnosis;
- •age >18 years;
- •ability to give informed consent to participate in a clinical study;
- •ability to swallow oral medications;
- •access to a smartphone
排除标准
- •allergy or intolerance to hydroxychloroquine (PlaquenilR);
- •weight less than 85 pounds;
- •eye disease affecting the retina;
- •severe kidney or liver disease;
- •G6PD-deficiency;
- •porphyria;
- •long QTc EKG abnormality or family history of this;
- •other major EKG abnormalities;
- •taking medications that can affect the QT interval including flecainide, amiodarone, digoxin, procainamide, propafenone, sotalol, quinidine, dofetilide, levofloxacin, ciprofloxacin, azithromycin, erythromycin, amitriptyline, doxepin, desipramine, imipramine, fluoxetine, sertraline, venlafaxine, quetiapine, haloperidol, droperidol, thioridazine, ziprasidone, furosemide, sumatriptan or zolmitriptan, cisapride, arsenic, dolasetron, or methadone;
- •current pregnancy;
- •current hospitalization;
- •symptomatic with fever or cough;
- •lack of access to a smartphone
研究组 & 干预措施
Hydroxychloroquine
Active Comparator
Randomization was 2:1 to HCQ 200 mg BID for 10 days
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
COVID-19 symptom development with positive PCR test
时间窗: within 14 days
The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14.
次要结局
- Hospital admission for COVID-19(within 14 days of study entry)
- Positive coronavirus PCR test without symptoms(By Day 14 (end of study))
- Death by Day 14(within 14 days of study entry)
- Symptom severity at specified time points(at Day 7 and at Day 14 from study entry)
- COVID -19 rate at study entry(Day 1 of study)
- HCQ discontinuation or study withdrawal(within 14 days of study entry)
- EKG changes during study(Day 1 thru Day 14 of study)
研究者
Luciano kapelusznik
Attending Physician
Bryn Mawr Hospital
研究点 (3)
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