A Study of CP-COV03 Compared With Placebo in Participants With Dengue (Part 1) and Dengue-like Illness (Part 2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CP-COV03, Placebo.
- Who it may be relevant to
- Registry conditions: Dengue. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of CP-COV03 in Dengue Patients (Part 1) / Dengue and Dengue-like Illness Patients (Part 2)
Overview
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.
Detailed 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.
Interventions
- Drug CP-COV03
Oral administration - Drug Placebo
Oral administration
Primary outcome measures
- [Part 1] Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: 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 [Time frame: Baseline, Day 1, 2, 3]
- [Part 2] Time to sustained symptom improvement up to Day 15 [Time frame: From baseline up to Day 15]
Secondary outcome measures (7)
- [Part 1, 2] Dengue viral load up to Day 6, 8, 15 [Time frame: Baseline, Day 1, 2, 3, 6, 8, 15]
- [Part 1] Time to sustained symptom improvement up to Day 15 [Time frame: From baseline up to Day 15]
- [Part 1, 2] Diagnosis of severe dengue fever or dengue hemorrhagic fever (DHF) [Time frame: From baseline up to Day 15]
- [Part 1] PK parameter - Area under the plasma concentration-time curve (AUC) [Time frame: Day 1, Day 7]
- [Part 1] PK parameter - Maximum observed plasma concentration (Cmax) [Time frame: Day 1, Day 7]
- [Part 1] PK parameter - Time to reach maximum plasma concentration (Tmax) [Time frame: Day 1, Day 7]
- [Part 1] PK parameter - Terminal elimination half-life (t½) [Time frame: Day 1, Day 7]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Vietnam · 2 centers
- The National Hospital of Tropical Diseases (NHTD) — Hanoi
- Tien Giang Provincial General Hospital — Mỹ Tho
Identifiers
NCT: NCT07576868 · DEN-201