NCT07576868招募中2 期
A Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of CP-COV03 in Dengue Patients (Part 1) / Dengue and Dengue-like Illness Patients (Part 2)
Hyundai Bioscience Co., Ltd.2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2026年4月9日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 2
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the efficacy, safety, and antiviral activity of CP-COV03 in adult patients with dengue infection.
详细描述
In Phase 2, approximately 210 patients with NS1-positive dengue within 72 hours of fever onset will be randomized to receive placebo or CP-COV03 at doses of 450, 900, or 1,350 mg/day for 7 days. An interim analysis by an independent Data and Safety Monitoring Board (DSMB) will support dose selection for Phase 3.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients who are 18 years or over of age at time of screening.
- •Patients who have at least two symptoms with a score of 2 or higher within 72 h from fever onset.
- •Patients who are diagnosed with dengue by NS1 positive (Phase 2- Part 1 only). And patients who are classified as dengue, zika, influenza, COVID-19 and others (Phase 3- Part 2 only)
排除标准
- •Patients who show severe dengue (WHO dengue guideline C, any severe symptoms or clinical laboratory results)
- •Patients who have previously received dengue vaccine
- •Patients who have chronic medical conditions such as uncontrolled diabetes mellitus, severe asthma requiring oral steroids or admission to the hospital in the previous 6 months for cardiac disease
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
CP-COV03 mid dose
Experimental
900 mg/day
干预措施: CP-COV03 (Drug)
CP-COV03 low dose
Experimental
450 mg/day
干预措施: CP-COV03 (Drug)
CP-COV03 high dose
Experimental
1,350 mg/day
干预措施: CP-COV03 (Drug)
研究者
研究点 (2)
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