Study of CP-COV03 Medicine Compared to Placebo for Treating Adults With Dengue or Dengue-like Illness

What this Trial Is About

Researchers are conducting a randomized, double-blind, placebo-controlled Phase 23 trial to assess the efficacy, safety, and antiviral effects of CP-COV03 in adults infected with dengue. The study aims to compare different doses of CP-COV03 against a placebo in patients diagnosed with dengue or dengue-like illnesses, including zika, influenza, and COVID-19. The trial is sponsored by Hyundai Bioscience Co., Ltd. and focuses on treatment outcomes in this population. In Phase 2, about 210 patients 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 7 days. An independent Data and Safety Monitoring Board will conduct an interim analysis to guide dose selection for Phase 3. The study involves oral administration of the drug and includes separate groups for each dose as well as a matching placebo group. Participants will be monitored for adverse events and changes in dengue viral load from baseline through Day 29, with viral load assessments on Days 1, 2, 3, 6, 8, and 15. Symptom improvement will be tracked up to Day 15. Pharmacokinetic parameters of the drug will also be measured on Days 1 and 7. Safety follow-up continues until Day 29. The total participation duration varies according to these assessments and treatment schedules.

A Study of CP-COV03 Compared With Placebo in Participants With Dengue (Part 1) and Dengue-like Illness (Part 2)