CP-COV03 versus placebo for adults with dengue or dengue-like illness
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 trial tests whether taking CP-COV03 for seven days helps adults with dengue (or dengue-like illnesses) recover faster and lower their viral levels compared with a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hyundai Bioscience Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Hanoi and 1 other locations) |
| Trial ID | NCT07576868 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 2/3 trial gives adults with recent-onset dengue or dengue-like illness either CP-COV03 or placebo and follows them for safety, antiviral effect, and clinical recovery. In Phase 2 about 210 NS1-positive patients within 72 hours of fever onset will be randomized to placebo or one of three daily doses (450, 900, or 1,350 mg) of CP-COV03 for seven days, with an independent DSMB performing an interim analysis to select the dose for Phase 3. Phase 3 expands enrollment to include patients with dengue-like illnesses and compares the selected dose against placebo for clinical and virologic outcomes. Key endpoints include symptom resolution, reduction in viral load, and monitoring for adverse events.
Who should consider this trial
Good fit: Adults aged 18 or older with recent-onset dengue symptoms—Phase 2 requires NS1 positivity and symptom onset within 72 hours with at least two moderate symptoms—are the intended participants.
Not a fit: People with severe dengue, prior dengue vaccination, or unstable chronic conditions such as uncontrolled diabetes or severe asthma were excluded and are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, CP-COV03 could shorten illness, reduce viral levels, and lower the risk of complications from dengue.
How similar studies have performed: There are few proven antiviral treatments for dengue and most candidate therapies have not shown clear clinical benefit, so this antiviral approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hanoi and 1 other locations
- The National Hospital of Tropical Diseases (NHTD) — Hanoi, Vietnam (Not_yet_recruiting)
- Tien Giang Provincial General Hospital — Mỹ Tho, Vietnam (Recruiting)
Study contacts
- Study coordinator: Central Contact Person
- Email: clinical@hyundaibio.com
- Phone: +82-1544-3194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.