CP-COV03 versus placebo for adults with dengue or dengue-like illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The National Hospital of Tropical Diseases (NHTD)
  Hanoi, Vietnam 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.