Adaptive platform testing antiviral medicines and a monoclonal antibody for early dengue
Adaptive Dengue Antiviral Platform Trial (ADAPT): a Phase 2 Randomized, Adaptive, Open Label Trial for Antiviral Screening in Patients With Early Symptomatic Dengue
This trial tests whether antiviral pills (molnupiravir or remdesivir) or a dengue monoclonal antibody can reduce the virus and help people with early dengue (within 48 hours of fever).
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Oxford University Clinical Research Unit, Vietnam Academic / other |
| Locations | 2 sites (Kuala Lumpur and 1 other locations) |
| Trial ID | NCT06551844 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label adaptive platform that compares multiple antiviral interventions against standard of care in people with lab-confirmed dengue and under 48 hours of fever. Participants are randomly allocated to available arms (currently molnupiravir, remdesivir, VIS513 monoclonal antibody, or no study drug) with no placebos used. The platform uses adaptive sample sizes and prespecified stopping rules to add promising therapies and drop poorly performing arms. Current sites include the Hospital for Tropical Diseases in Ho Chi Minh City and Universiti Malaya Medical Centre in Kuala Lumpur, with local ethical approvals in place.
Who should consider this trial
Good fit: Ideal candidates are people with lab-confirmed dengue who present within 48 hours of fever onset, meet the age and consent requirements for the tested therapy, and can remain hospitalized for the intervention and follow-up visits.
Not a fit: People with severe dengue at baseline, pregnant or breastfeeding women, or those with clear alternative diagnoses are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the interventions could shorten illness, reduce viral load, and provide the first effective antiviral treatment options for early dengue.
How similar studies have performed: Antiviral treatments for dengue remain largely experimental with limited clinical success so far, so this platform is testing promising but not widely proven approaches.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kuala Lumpur and 1 other locations
- Universiti Malaya Medical Centre — Kuala Lumpur, Malaysia (Not_yet_recruiting)
- Hospital for Tropical Diseases, Ho Chi Minh city — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Principal investigator: Sophie Yacoub, MD., PhD. — University of Oxford, UK
- Study coordinator: Sophie Yacoub, MD., PhD.
- Email: syacoub@oucru.org
- Phone: +84 77728736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.