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)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Viet Nam
The National Hospital of Tropical Diseases (NHTD)
NOT_YET_RECRUITING
Hanoi
Tien Giang Provincial General Hospital
RECRUITING
Mỹ Tho
Contact Information
Primary
Central Contact Person
clinical@hyundaibio.com
+82-1544-3194
Time Frame
Start Date: 2026-04-09
Estimated Completion Date: 2027-05
Participants
Target number of participants: 210
Treatments
Experimental: CP-COV03 low dose
450 mg/day
Experimental: CP-COV03 mid dose
900 mg/day
Experimental: CP-COV03 high dose
1,350 mg/day
Placebo_comparator: Placebo
Matching placebo
Related Therapeutic Areas
Sponsors
Leads: Hyundai Bioscience Co., Ltd.