Actively Recruiting
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)
Led by Hyundai Bioscience Co., Ltd. · Updated on 2026-05-08
210
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and antiviral activity of CP-COV03 in adults with dengue infection in this randomized, double-blind, placebo-controlled Phase 2/3 clinical trial. The study aims to better understand how well CP-COV03 works compared to a placebo in treating dengue and dengue-like illnesses. In Phase 2, about 210 patients diagnosed with NS1-positive dengue within 72 hours of fever onset will be randomly assigned to receive either placebo or CP-COV03 at doses of 450 mg, 900 mg, or 1,350 mg per day for seven days. An independent Data and Safety Monitoring Board will analyze results to decide the best dose for Phase 3. Participants in Phase 3 include those with dengue and dengue-like illnesses such as zika, influenza, or COVID-19. During the study, researchers will monitor adverse events and serious adverse events from day 1 to day 29. They will measure dengue viral load at several time points up to day 15 and track symptom improvement. Additional tests will assess the drug's behavior in the body, including how much is absorbed and how long it stays in the bloodstream. Participants can expect regular visits for evaluations, monitoring, and safety follow-up during the trial period, which starts in April 2026 and continues until May 2027.
CONDITIONS
Brief Title
A Study of CP-COV03 Compared With Placebo in Participants With Dengue (Part 1) and Dengue-like Illness (Part 2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 hours from fever onset.
- Patients diagnosed with dengue by NS1 positive (Phase 2 - Part 1 only).
- Patients classified as dengue, zika, influenza, COVID-19, or other dengue-like illnesses (Phase 3 - Part 2 only).
You will not qualify if you...
- Patients who show severe dengue according to WHO dengue guidelines or have any severe symptoms or abnormal clinical laboratory results.
- Patients who have previously received a dengue vaccine.
- Patients with chronic medical conditions such as uncontrolled diabetes mellitus.
- Patients with severe asthma requiring oral steroids or hospital admission in the last 6 months for cardiac disease.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive CP-COV03 or placebo orally once daily for 7 days to evaluate safety and efficacy.
Daily visits for 7 days
Duration - Up to 22 days
Participants are monitored for safety and symptom improvement after treatment ends.
Approximately 3 visits up to Day 29
Trial Site Locations
Total: 2 locations
1
The National Hospital of Tropical Diseases (NHTD)
Hanoi, Vietnam
Not Yet Recruiting
2
Tien Giang Provincial General Hospital
Mỹ Tho, Vietnam
Actively Recruiting
Research Team
C
Central Contact Person
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here