NCT04334382Unknown3 期
Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 1,550
- 试验地点
- 2
- 主要终点
- Hospitalization within 14 days of enrollment
研究概览
简要总结
This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, Age>44 years, competent to provide consent
- •Confirmed COVID-19, via a positive nucleic acid assay for COVID-19 within the last 7 days
排除标准
- •Participants already prescribed chloroquine, hydroxychloroquine, or azithromycin
- •Allergy to hydroxychloroquine or azithromycin
- •History of bone marrow transplant
- •Known G6PD (Glucose-6-Phosphate Dehydrogenase Deficiency) deficiency
- •Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate < 20ml/min/1.73m2
- •Liver disease (e.g. Child Pugh score ≥ B or AST (Aspartate Transaminase)>2 times upper limit)
- •Psoriasis
- •Porphyria
- •Known cardiac conduction delay (QTc > 500mSec) or taking any prescription medications known to prolong QT interval
- •Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
- •Weight < 35kg
- •Inability to follow-up - no cell phone or no address or not Spanish or English speaking
- •Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
- •No symptoms attributable to COVID-19
- •Pregnant or nursing
研究组 & 干预措施
Hydroxychloroquine
Experimental
干预措施: Hydroxychloroquine (Drug)
Azithromycin
Active Comparator
干预措施: Azithromycin (Drug)
结局指标
主要结局
Hospitalization within 14 days of enrollment
时间窗: From enrollment to 14 days after enrollment
Admitted to a hospital (not merely kept for emergency room observation)
次要结局
- ICU-free days at 28 days(Admission (day 1) to 28 days after admission (day 28))
- Hospital-free days at 28 days(Admission (day 1) to 28 days after admission (day 28))
- Duration of COVID-19-attributable symptoms(From enrollment to 14 days after enrollment)
- Ventilator-free days at 28 days(Admission (day 1) to 28 days after admission (day 28))
研究者
Brandon Webb
Director, Transplant Infectious Diseases
Intermountain Health Care, Inc.
研究点 (2)
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