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.
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)
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
Parallel
CP-COV03
DrugOral administration
Placebo
DrugOral administration
[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.
[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).
[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.
[Part 1, 2] Dengue viral load up to Day 6, 8, 15
The viral load is measured in plasma samples using reverse transcription polymerase chain reaction (RT-PCR).
[Part 1] 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.
[Part 1, 2] Diagnosis of severe dengue fever or dengue hemorrhagic fever (DHF)
Assessment of the clinical course of dengue fever
[Part 1] PK parameter - Area under the plasma concentration-time curve (AUC)
Pharmacokinetic assessment of CP-COV03 in dengue fever patients
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