Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Development of COVID-19 symptoms during HCQ preventive therapy in staff
研究概览
简要总结
Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.
详细描述
This study is designed to evaluate the prophylactic efficacy of HCQ in COVID-19 cases with mild to moderate symptoms and in the hospital staff engaged in attending infected patients.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Months 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years of age at the time of enrollment
- •COVID-19 test positive patients with mild-moderate symptoms including fever >37.50 F
- •Consecutive consenting staff at ICU, ER and COVID-19 unit that have never been diagnosed with COVID-19
排除标准
- •Exclusion criteria:
- •Hepatic cirrhosis or active hepatitis B or C
- •Severe renal disease
- •Hospitalized for severe symptoms of COVID-19 (ARDS), on mechanical ventilation or ECMO
- •Contraindication to HCQ
- •Using HCQ for some other condition (i.e. SLE, rheumatoid arthritis)
- •Pregnant or breast feeding
- •Known history of long QT syndrome (QTc >500 ms on electrocardiogram)
- •Seizure disorder
- •Body weight <50kg
- •Psoriasis
- •Unwilling to provide informed consent
研究组 & 干预措施
HCQ arm
COVID-19 positive cases will receive receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.
Staff randomized to this group will receive HCQ sulfate 400 mg/week for 4 weeks
干预措施: Hydroxychloroquine Sulfate (Drug)
结局指标
主要结局
Development of COVID-19 symptoms during HCQ preventive therapy in staff
时间窗: 1 month
Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy
Time to reach normal body temperature
时间窗: 1 month
Time to reach normal body temperature (TNBT), ≤37.50 C
次要结局
- Worsening of symptoms in COVID-19 patients(1 month)
- COVID-19 test result at follow-up in patients(6 days)
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation