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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-COV03 low dose | Experimental | 450 mg/day |
|
| CP-COV03 mid dose | Experimental | 900 mg/day |
|
| CP-COV03 high dose | Experimental | 1,350 mg/day |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-COV03 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| [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 |
| Measure | Description | Time Frame |
|---|---|---|
| [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). | Baseline, Day 1, 2, 3, 6, 8, 15 |
| [Part 1] Time to sustained symptom improvement up to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Central Contact Person | Contact | +82-1544-3194 | clinical@hyundaibio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The National Hospital of Tropical Diseases (NHTD) | Recruiting | Hanoi | Vietnam | |||
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| Placebo | Drug | Oral administration |
|
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 |
| [Part 1, 2] Diagnosis of severe dengue fever or dengue hemorrhagic fever (DHF) | Assessment of the clinical course of dengue fever | From baseline up to Day 15 |
| [Part 1] PK parameter - Area under the plasma concentration-time curve (AUC) | Pharmacokinetic assessment of CP-COV03 in dengue fever patients | Day 1, Day 7 |
| [Part 1] PK parameter - Maximum observed plasma concentration (Cmax) | Pharmacokinetic assessment of CP-COV03 in dengue fever patients | Day 1, Day 7 |
| [Part 1] PK parameter - Time to reach maximum plasma concentration (Tmax) | Pharmacokinetic assessment of CP-COV03 in dengue fever patients | Day 1, Day 7 |
| [Part 1] PK parameter - Terminal elimination half-life (t½) | Pharmacokinetic assessment of CP-COV03 in dengue fever patients | Day 1, Day 7 |
| Tien Giang Provincial General Hospital |
| Recruiting |
| Mỹ Tho |
| Vietnam |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |