NCT04721535终止3 期
A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年6月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Percentage of subjects with COVID-19
研究概览
简要总结
To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults over the age of 19 as of the signed date in written consent
- •Subjects in self-quarantine who contact from COVID-19 confirmed patient
- •Subjects who have COVID-19 negative RT-PCR result
- •Subjects with no symptoms of COVID-19
排除标准
- •Subjects who cannot orally administer the investigational products
- •Subjects who need administration of immunosuppressants
- •Subjects who are allergic or sensitive to investigational products or its ingredients
- •Subjects who have a history of drug and/or alcohol abuse within 12 months before screening
- •Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
研究组 & 干预措施
DWJ1248
Experimental
Camostat mesilate 200mg
干预措施: DWJ1248 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects with COVID-19
时间窗: Up to 14 days
positive result in RT-PCR test
次要结局
- Percentage of subjects who experience intensive care unit (ICU)(Days 3, 7, 14, and 28)
- Percentage of subjects with hospitalization(Days 3, 7, 14, and 28)
研究者
研究点 (1)
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