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NCT Number: NCT07576868

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

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Key information

Conditions

Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The National Hospital of Tropical Diseases (NHTD), Hanoi, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-COV03

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. [Part 1] Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From start of study intervention (Day 1) up to end of safety follow-up (Day 29)

    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.

  2. [Part 1] Average of dengue viral load on Day 3

    Time frame: Baseline, Day 1, 2, 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).

  3. [Part 2] Time to sustained symptom improvement up to Day 15

    Time frame: From baseline 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.

Secondary outcomes

  1. [Part 1, 2] Dengue viral load up to Day 6, 8, 15

    Time frame: Baseline, Day 1, 2, 3, 6, 8, 15

    The viral load is measured in plasma samples using reverse transcription polymerase chain reaction (RT-PCR).

  2. [Part 1] Time to sustained symptom improvement up to Day 15

    Time frame: From baseline 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.

  3. [Part 1, 2] Diagnosis of severe dengue fever or dengue hemorrhagic fever (DHF)

    Time frame: From baseline up to Day 15

    Assessment of the clinical course of dengue fever

  4. [Part 1] PK parameter - Area under the plasma concentration-time curve (AUC)

    Time frame: Day 1, Day 7

    Pharmacokinetic assessment of CP-COV03 in dengue fever patients

  5. [Part 1] PK parameter - Maximum observed plasma concentration (Cmax)

    Time frame: Day 1, Day 7

    Pharmacokinetic assessment of CP-COV03 in dengue fever patients

  6. [Part 1] PK parameter - Time to reach maximum plasma concentration (Tmax)

    Time frame: Day 1, Day 7

    Pharmacokinetic assessment of CP-COV03 in dengue fever patients

  7. [Part 1] PK parameter - Terminal elimination half-life (t½)

    Time frame: Day 1, Day 7

    Pharmacokinetic assessment of CP-COV03 in dengue fever patients

Study contacts

Contact information is provided by the study sponsor or research team.

Central Contact Person

CONTACT

[email protected]

+82-1544-3194

Sponsors and collaborators

Lead sponsor

Hyundai Bioscience Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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