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

RecruitingPhase 2, Phase 3

Sponsor: Hyundai Bioscience Co., Ltd.

Conditions: Dengue

Interventions: CP-COV03, Placebo

Countries: Vietnam

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Hanoi, Vietnam
Mỹ Tho, Vietnam