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

ConditionDengue
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHyundai Bioscience Co., Ltd.

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Treatments tested in this trial

  • CP-COV03
  • Placebo

Treatment groups

210 Participants
are divided into 4 treatment groups

Sponsors and collaborators