DenguePhase 2/3NCT07576868
A Study of CP-COV03 Compared With Placebo in Participants With Dengue (Part 1) and Dengue-like Illness (Part 2)
A Phase 2/3 study testing CP-COV03 in people with Dengue, run by Hyundai Bioscience Co., Ltd. at 2 sites in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dengue
- What is being tested?
- CP-COV03
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 2 sitesVietnam
- Study dates
- 9 Apr 2026to May 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
The National Hospital of Tropical Diseases (NHTD)
Hanoi
- Recruiting
Tien Giang Provincial General Hospital
Mỹ Tho
About this study
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)
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.
Read the 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.
- Conditions
- Dengue
- Being tested
- CP-COV03, Placebo
- Keywords
- dengue, dengue treatment, dengue antiviral
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-COV03Drug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| CP-COV03 low dose | Experimental | 450 mg/day Receives: Drug: CP-COV03 |
| CP-COV03 mid dose | Experimental | 900 mg/day Receives: Drug: CP-COV03 |
| CP-COV03 high dose | Experimental | 1,350 mg/day Receives: Drug: CP-COV03 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: 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).
Measured: 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.
Measured: From baseline up to Day 15
Secondary outcomes (7)
[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).
Measured: Baseline, Day 1, 2, 3, 6, 8, 15
[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.
Measured: 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
Measured: 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
Measured: Day 1, Day 7
[Part 1] PK parameter - Maximum observed plasma concentration (Cmax)
Pharmacokinetic assessment of CP-COV03 in dengue fever patients
Measured: Day 1, Day 7
[Part 1] PK parameter - Time to reach maximum plasma concentration (Tmax)
Pharmacokinetic assessment of CP-COV03 in dengue fever patients
Measured: Day 1, Day 7
[Part 1] PK parameter - Terminal elimination half-life (t½)
Pharmacokinetic assessment of CP-COV03 in dengue fever patients
Measured: Day 1, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start9 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyundai Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576868
- Sponsor's protocol ID
- DEN-201
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07576868
- Acronym / sponsor ID
- DEN-201
- Conditions
- Dengue
- Keywords
- dengue, dengue treatment, dengue antiviral
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hyundai Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CP-COV03 low dose | Experimental | Drug: CP-COV03450 mg/day |
| CP-COV03 mid dose | Experimental | Drug: CP-COV03900 mg/day |
| CP-COV03 high dose | Experimental | Drug: CP-COV031,350 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-COV03Oral administration | Drug | CP-COV03 high dose, CP-COV03 low dose, CP-COV03 mid dose |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
[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)
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
Time frame: Baseline, Day 1, 2, 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
Time frame: From baseline 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.
7 secondary outcomes
[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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CP-COV03 in people with Dengue, run by Hyundai Bioscience Co., Ltd. at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Central Contact Person (+82-1544-3194, clinical@hyundaibio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.