NCT04372017终止3 期
Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test.
研究概览
简要总结
This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.
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
- Double (Participant, Investigator)
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
- •Inclusion Criteria Cohort A:
- •≥ 18 years old
- •Employee of healthcare organization in South Dakota or Sanford Health employee in any location and with exposure to a person with COVID-19 within the last 5 days
- •Occupational exposure as determined by the participant's employee health department (i.e. not wearing the proper Personal Protective Equipment (PPE))
- •Criteria according to Center for Disease Control (CDC) guidelines
- •Community exposure (within 6 feet for at least 15 minutes)
- •No current symptoms attributable to COVID-19, per HCW report (fever, cough, difficulty breathing, sore throat)
- •No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
- •Ability to provide informed consent
- •Inclusion Criteria - Cohort B
- •≥ 18 years old
- •High-risk person who had close contact (i.e. within 6 feet for at least 15 minutes) with a COVID-19 positive person within the last 5 days and is a South Dakota resident or high-risk person with close household contact of a COVID-19 positive Sanford employee
- •High-risk person defined by:
- •Age 18-44 with 2 or more comorbidities listed below
- •Age 45-79 with any comorbid condition listed below
- •Age 80 and above (regardless of comorbid conditions)
- •Co-morbid list
- •Congestive Heart Failure (CHF)
- •Chronic lung disease (Includes any of the following: asthma, chronic obstructive pulmonary disease, emphysema)
- •Solid organ transplant or immunosuppression (Defined as an outpatient prescription of greater than 10 mg/day of prednisone or equivalent, use of chemotherapy, or use of immunosuppressive agents for solid organ transplant or for an autoimmune disease.)
- •Chronic Kidney Disease or End Stage Renal Disease
- •Diabetes mellitus
- •Cardiovascular disease/Hypertension
- •Smoking/Vaping (currently using or history of using in the past 1 year)
- •Obesity (calculated by height and weight per participant report)
- •Hyperlipidemia
- •No current symptoms attributable to COVID-19
- •No prior COVID-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion)
- •Ability to provide informed consent
- •Confirmed review of concomitant medications (with emphasis on cardiac medications)
- •Exclusion Criteria Cohort A & B:
- •Known allergy to hydroxychloroquine or quinine
- •Known history of long QT syndrome
- •Known history of arrhythmia or dysrhythmia
- •Known current QTc >500 ms
- •Known G6PD deficiency
- •Known history of hypoglycemia
- •Pregnant or Nursing by patient history
- •Use of any of the following concomitant medications: See Appendix D for Exclusion medication list
- •Concurrent diagnosis of dermatitis, porphyria, or psoriasis
- •History of chronic liver disease, including cirrhosis and/or diagnosis of hepatitis (infectious, idiopathic, or immune)
- •History of chronic kidney disease
- •Pre-existing retinopathy
- •Already taking hydroxychloroquine
- •Any condition or medication in the opinion of the investigator that would prohibit the use of hydroxychloroquine
- •Enrollment in another clinical with investigational drug or device
- •Inability to swallow pills
- •Adults unable to provide informed consent
排除标准
- 未提供
研究组 & 干预措施
Cohort A: Healthcare worker (hydroxychloroquine)
Experimental
干预措施: Hydroxychloroquine (Drug)
Cohort A: Healthcare worker (placebo)
Placebo Comparator
干预措施: Vitamin D (Dietary Supplement)
Cohort B: High-Risk participant (hydroxychloroqine)
Experimental
干预措施: Hydroxychloroquine (Drug)
Cohort B: High-Risk participant (placebo)
Placebo Comparator
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Cohort A: Percentage of COVID-19 Exposed Healthcare Workers Treated With Hydroxychloroquine With a Positive COVID-19 Test.
时间窗: At enrollment completion outcome 1 will be analyzed.
Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.
Cohort B: Percentage of COVID-19 Exposed High-risk Individuals Treated With Hydroxychloroquine With a Positive COVID-19 Test.
时间窗: At enrollment completion outcome 2 will be analyzed.
Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.
次要结局
未报告次要终点
研究者
研究点 (1)
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