Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- COVID Ordinal Outcomes Scale at 14 Days
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 hospitalized patients 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age ≥ 18 years)
- •Confirmed OR suspected COVID-19,
- •Confirmed: Positive assay for COVID-19 within the last 10 days
- •Suspected: Pending assay for COVID-19 WITH high clinical suspicion
- •Scheduled for admission or already admitted to an inpatient bed
排除标准
- •Allergy to hydroxychloroquine or azithromycin
- •History of bone marrow transplant
- •Known G6PD deficiency
- •Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
- •Psoriasis
- •Porphyria
- •Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol
- •Known history of long QT syndrome
- •Current known QTc>500 msec
- •Pregnant or nursing
- •Weight < 35kg
- •Seizure disorder
- •Severe liver disease
- •Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19
- •Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.
- •Treating physician refuses to allow patient participation in the study
- •Unable to obtain informed consent
- •Prior enrollment in this study
研究组 & 干预措施
Azithromycin
干预措施: Azithromycin (Drug)
Hydroxychloroquine
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
COVID Ordinal Outcomes Scale at 14 Days
时间窗: Assessed once on day 14 after enrollment (enrollment is day 0)
Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
次要结局
- Hospital-free Days at 28 Days(Admission (day 1) to 28 days after admission (day 28))
- Time to a 1-point Decrease in the WHO Ordinal Recovery Score(Admission (day 1) to 14 days after admission (day 14))
- Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator)(Admission (day 1) to 28 days after admission (day 28))
- ICU-free Days at 28 Days(Admission (day 1) to 28 days after admission (day 28))
研究者
Samuel Brown
Director, Critical Care Research
Intermountain Health Care, Inc.