NCT04330144撤回3 期
A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The rate of COVID-19
研究概览
简要总结
There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2.
- Primary end point: comparison the rate of COVID-19 between PEP with HCQ and control group.
- Secondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment).
- Safety comparison: Safety verification by identifying major side effects in the HCQ group."
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A contact person from confirmed case of SARS-CoV-2 infection
- •Medical staff exposed from confirmed case of SARS-CoV-2 infection in hospitals
- •Persons exposed to SARS-CoV-2 in COVID-19 outbreak situation with certain workplaces, religious groups, and military, etc.
- •Subjects of study include both symptomatic and asymptomatic contacts.
排除标准
- •Hypersensitivity to Chloroquine or Hydroxychloroquine
- •Those who are contraindicated in Hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc.
- •Human immunodeficiency virus (HIV) infected person
- •Patients with autoimmune disease (Systemic lupus erythematosus, Mixed connective tissue disease)
- •Patients with autoimmune rheumatoid inflammatory disease (AIIRD; Autoimmune inflammatory rheumatic diseases - Ankylosing spondylitis, Rheumatic arthritis, Psoriatic arthritis)
- •Arrhythmia, liver cirrhosis of Child Pugh C, chronic renal failure with eGFR≤30mL / min / 1.73m2
- •A person who is positive in the COVID-19 screening PCR test before starting PEP
研究组 & 干预措施
administration of hydroxychloroquine as PEP
Experimental
干预措施: Hydroxychloroquine as post exposure prophylaxis (Drug)
control with no PEP
Active Comparator
干预措施: Others(No intervention) (Other)
结局指标
主要结局
The rate of COVID-19
时间窗: PCR test of COVID-19 at 14 days after the contact from confirmed case
After postexposure prophylaxis, the rate of COVID-19 conversion between two groups
次要结局
未报告次要终点
研究者
Young Goo Song
Professor, Department of Internal Medicine,
Gangnam Severance Hospital
研究点 (1)
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