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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Dengue
• Intervention / Treatment: Drug: Placebo; Drug: CP-COV03

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Central Contact Person; Phone Number: +82-1544-3194; Email: clinical@hyundaibio.com

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Not yet recruiting
    • The National Hospital of Tropical Diseases (NHTD)
  • Mỹ Tho, Vietnam
    • Recruiting
    • Tien Giang Provincial General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Oral administration
Experimental: CP-COV03 low dose; 450 mg/day	Drug: CP-COV03; Oral administration
Experimental: CP-COV03 mid dose; 900 mg/day	Drug: CP-COV03; Oral administration
Experimental: CP-COV03 high dose; 1,350 mg/day	Drug: CP-COV03; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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.	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).	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.	From baseline up to Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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).	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.	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	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	Day 1, Day 7
[Part 1] PK parameter - Maximum observed plasma concentration (Cmax)	Pharmacokinetic assessment of CP-COV03 in dengue fever patients	Day 1, Day 7
[Part 1] PK parameter - Time to reach maximum plasma concentration (Tmax)	Pharmacokinetic assessment of CP-COV03 in dengue fever patients	Day 1, Day 7
[Part 1] PK parameter - Terminal elimination half-life (t½)	Pharmacokinetic assessment of CP-COV03 in dengue fever patients	Day 1, Day 7

Collaborators and Investigators

• Sponsor: Hyundai Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dengue; dengue treatment; dengue antiviral
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; RNA Virus Infections; Virus Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue
• Other Study ID Numbers: DEN-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No