A Study of CP-COV03 Compared With Placebo in Participants With Dengue (Part 1) and Dengue-like Illness (Part 2)
2026年5月4日 更新者：Hyundai Bioscience Co., Ltd.
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)
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
210
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Central Contact Person
- 电话号码：+82-1544-3194
- 邮箱：clinical@hyundaibio.com
学习地点
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Hanoi、越南
- 尚未招聘
- The National Hospital of Tropical Diseases (NHTD)
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Mỹ Tho、越南
- 招聘中
- Tien Giang Provincial General Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
匹配安慰剂
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口服给药
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实验性的：CP-COV03 low dose
450 mg/day
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Oral administration
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实验性的：CP-COV03 mid dose
900 mg/day
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Oral administration
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实验性的：CP-COV03 high dose
1,350 mg/day
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Oral administration
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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[Part 1] Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：From start of study intervention (Day 1) up to end of safety follow-up (Day 29)
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The incidence and severity of AEs / SAEs will be summarized by treatment group.
Clinical laboratory abnormalities, vital sign changes, and electrocardiogram (ECG) findings will be reported as AEs if they are considered clinically significant.
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From start of study intervention (Day 1) up to end of safety follow-up (Day 29)
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[Part 1] Average of dengue viral load on Day 3
大体时间：Baseline, Day 1, 2, 3
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The area under the log-transformed DENV RNA viral load (log10 VL) curve from baseline until Day 3 will be determined.
The viral load is measured in plasma samples using reverse transcription polymerase chain reaction (RT-PCR).
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Baseline, Day 1, 2, 3
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[Part 2] Time to sustained symptom improvement up to Day 15
大体时间：From baseline up to Day 15
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Sustained improvement of each targeted symptom is defined as the event occurring on the first 2 consecutive days when each symptom scored as moderate or severe at the time of enrollment is scored as mild or absent, and those scored mild or absent at the time of enrollment are scored as absent.
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From baseline up to Day 15
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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[Part 1, 2] Dengue viral load up to Day 6, 8, 15
大体时间：Baseline, Day 1, 2, 3, 6, 8, 15
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The viral load is measured in plasma samples using reverse transcription polymerase chain reaction (RT-PCR).
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Baseline, Day 1, 2, 3, 6, 8, 15
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[Part 1] Time to sustained symptom improvement up to Day 15
大体时间：From baseline up to Day 15
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Sustained improvement of each targeted symptom is defined as the event occurring on the first 2 consecutive days when each symptom scored as moderate or severe at the time of enrollment is scored as mild or absent, and those scored mild or absent at the time of enrollment are scored as absent.
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From baseline up to Day 15
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[Part 1, 2] Diagnosis of severe dengue fever or dengue hemorrhagic fever (DHF)
大体时间：From baseline up to Day 15
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Assessment of the clinical course of dengue fever
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From baseline up to Day 15
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[Part 1] PK parameter - Area under the plasma concentration-time curve (AUC)
大体时间：Day 1, Day 7
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Pharmacokinetic assessment of CP-COV03 in dengue fever patients
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Day 1, Day 7
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[Part 1] PK parameter - Maximum observed plasma concentration (Cmax)
大体时间：Day 1, Day 7
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Pharmacokinetic assessment of CP-COV03 in dengue fever patients
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Day 1, Day 7
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[Part 1] PK parameter - Time to reach maximum plasma concentration (Tmax)
大体时间：Day 1, Day 7
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Pharmacokinetic assessment of CP-COV03 in dengue fever patients
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Day 1, Day 7
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[Part 1] PK parameter - Terminal elimination half-life (t½)
大体时间：Day 1, Day 7
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Pharmacokinetic assessment of CP-COV03 in dengue fever patients
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Day 1, Day 7
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月9日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年5月1日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月8日
研究记录更新
最后更新发布 (实际的)
2026年5月8日
上次提交的符合 QC 标准的更新
2026年5月4日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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