Malaysia, Vietnam500 participantsStarted 2026-04-20
Plain-language 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
Who can participate
Age range10 Years
SexALL
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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 …
What they're measuring
1
Viral clearance rate
Timeframe: From randomization until day 5 of study
2
Number of AEs (grade 3, 4 and 5)
Timeframe: Until day 30 post-enrolment
Trial details
NCT IDNCT06551844
SponsorOxford University Clinical Research Unit, Vietnam