NCT07576868

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
12mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026May 2027

Study Start

First participant enrolled

April 9, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

April 27, 2026

Last Update Submit

May 4, 2026

Conditions

Dengue

Keywords

denguedengue treatmentdengue antiviral

Outcome Measures

Primary Outcomes (3)

  • [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 Outcomes (7)

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

    Baseline, Day 1, 2, 3, 6, 8, 15

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

    From baseline up to Day 15

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

    From baseline up to Day 15

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

    Day 1, Day 7

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

    Day 1, Day 7

  • +2 more secondary outcomes

Study Arms (4)

CP-COV03 low dose

EXPERIMENTAL

450 mg/day

Drug: CP-COV03

CP-COV03 mid dose

EXPERIMENTAL

900 mg/day

Drug: CP-COV03

CP-COV03 high dose

EXPERIMENTAL

1,350 mg/day

Drug: CP-COV03

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

CP-COV03DRUG

Oral administration

CP-COV03 high doseCP-COV03 low doseCP-COV03 mid dose
PlaceboDRUG

Oral administration

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The National Hospital of Tropical Diseases (NHTD)

Hanoi, Vietnam

NOT YET RECRUITING

Tien Giang Provincial General Hospital

Mỹ Tho, Vietnam

RECRUITING

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Central Study Contacts

Central Contact Person

CONTACT

+82-1544-3194clinical@hyundaibio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 8, 2026

Study Start

April 9, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations

VN(2)