A Phase 2/3 interventional study of CP-COV03 and Placebo in Dengue, sponsored by Hyundai Bioscience Co., Ltd.. Recruiting at 2 sites in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Hyundai Bioscience Co., Ltd. · Phase 2/3, Interventional, and Treatment
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.
In Phase 2, approximately 210 patients with NS1-positive dengue within 72 hours of fever onset will be randomized to receive placebo or CP-COV03 at doses of 450, 900, or 1,350 mg/day for 7 days. An interim analysis by an independent Data and Safety Monitoring Board (DSMB) will support dose selection for Phase 3.
Exclusion Criteria:
450 mg/day
Drug: CP-COV03
900 mg/day
Drug: CP-COV03
1,350 mg/day
Drug: CP-COV03
Matching placebo
Drug: Placebo
Oral administration
Oral administration
[Part 1] Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The incidence and severity of AEs / SAEs will be summarized by treatment group. Clinical laboratory abnormalities, vital sign changes, and electrocardiogram (ECG) findings will be reported as AEs if they are considered clinically significant.
Time frame: From start of study intervention (Day 1) up to end of safety follow-up (Day 29)
[Part 1] Average of dengue viral load on Day 3
The area under the log-transformed DENV RNA viral load (log10 VL) curve from baseline until Day 3 will be determined. The viral load is measured in plasma samples using reverse transcription polymerase chain reaction (RT-PCR).
Time frame: Baseline, Day 1, 2, 3
[Part 2] Time to sustained symptom improvement up to Day 15
Sustained improvement of each targeted symptom is defined as the event occurring on the first 2 consecutive days when each symptom scored as moderate or severe at the time of enrollment is scored as mild or absent, and those scored mild or absent at the time of enrollment are scored as absent.
Time frame: From baseline up to Day 15
[Part 1, 2] Dengue viral load up to Day 6, 8, 15
The viral load is measured in plasma samples using reverse transcription polymerase chain reaction (RT-PCR).
Time frame: Baseline, Day 1, 2, 3, 6, 8, 15
[Part 1] Time to sustained symptom improvement up to Day 15
Sustained improvement of each targeted symptom is defined as the event occurring on the first 2 consecutive days when each symptom scored as moderate or severe at the time of enrollment is scored as mild or absent, and those scored mild or absent at the time of enrollment are scored as absent.
Time frame: From baseline up to Day 15
[Part 1, 2] Diagnosis of severe dengue fever or dengue hemorrhagic fever (DHF)
Assessment of the clinical course of dengue fever
Time frame: From baseline up to Day 15
[Part 1] PK parameter - Area under the plasma concentration-time curve (AUC)
Pharmacokinetic assessment of CP-COV03 in dengue fever patients
Time frame: Day 1, Day 7
[Part 1] PK parameter - Maximum observed plasma concentration (Cmax)
Pharmacokinetic assessment of CP-COV03 in dengue fever patients
Time frame: Day 1, Day 7
[Part 1] PK parameter - Time to reach maximum plasma concentration (Tmax)
Pharmacokinetic assessment of CP-COV03 in dengue fever patients
Time frame: Day 1, Day 7
[Part 1] PK parameter - Terminal elimination half-life (t½)
Pharmacokinetic assessment of CP-COV03 in dengue fever patients
Time frame: Day 1, Day 7
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Hyundai Bioscience Co., Ltd.