NCT06551844 Adaptive Dengue Antiviral Platform Trial
| NCT ID | NCT06551844 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oxford University Clinical Research Unit, Vietnam |
| Condition | Dengue |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2026-04-20 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized, open-label adaptive platform trial aiming to screen the antiviral effectiveness of the experimental drug(s) in early dengue infection * Primary objectives: * To determine the antiviral effectiveness of the experimental drug(s) in early dengue infection * To assess the safety and tolerability of the experimental drug(s) in dengue patients * Secondary objective: * To assess the effect of the experimental drug(s) in dengue patients on physiological, clinical and virological parameters
Eligibility Criteria
Inclusion Criteria: * Female or male patients with a clinical diagnosis of dengue virus infection and less than 48 hours of fever * Positive NS1 rapid diagnostic test * \>= 10 years or ≥ 18 years of age (depending on license of therapeutic being evaluated) * Patient is able to give written informed consent or assent for full participation in the study. * Agreement to stay in hospital for duration of the intervention (most will be 5 days) and follow-up visits at day 30 and 60 post enrolment. Exclusion Criteria: * Meets criteria for severe dengue at baseline (severe plasma leakage leading to dengue shock syndrome, fluid accumulation with respiratory distress, severe bleeding, severe organ involvement - AST/ALT\>1000 U/L, impaired consciousness, multiple organ dysfunction) * Pregnancy (either clinically confirmed or by urine dipstick for human chorionic gonadotrophin hormone) * Breastfeeding women * Localising features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis * Renal failure (baseline eGFR \< 30ml/min) * History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders * History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed) * Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant * Participation or planned participation in a study involving the administration of an investigational compound within the past one month.
Contact & Investigator
Sophie Yacoub, MD., PhD.
PRINCIPAL INVESTIGATOR
University of Oxford, UK
Frequently Asked Questions
Who can join the NCT06551844 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying Dengue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06551844 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06551844 currently recruiting?
Yes, NCT06551844 is actively recruiting participants. Contact the research team at syacoub@oucru.org for enrollment information.
Where is the NCT06551844 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia, Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06551844 clinical trial?
NCT06551844 is sponsored by Oxford University Clinical Research Unit, Vietnam. The principal investigator is Sophie Yacoub, MD., PhD. at University of Oxford, UK. The trial plans to enroll 500 participants.