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

Hyundai Bioscience Co., Ltd.

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Dengue

Treatments: Drug: Placebo; Drug: CP-COV03

Study type: Interventional

Funder types: Industry

Identifiers

NCT07576868

DEN-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 4 patient groups, including a placebo group

CP-COV03 low dose

Experimental group

Description:

450 mg/day

Treatment:

Drug: CP-COV03

CP-COV03 mid dose

Experimental group

Description:

900 mg/day

Treatment:

Drug: CP-COV03

CP-COV03 high dose

Experimental group

Description:

1,350 mg/day

Treatment:

Drug: CP-COV03

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo