RECRUITING Phase 2 ClinicalTrials.gov

Adaptive Dengue Antiviral Platform Trial

Sponsor: Oxford University Clinical Research Unit, Vietnam • ClinicalTrials.gov ID: NCT06551844

Registry updated: 2026-09-28

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Description

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

Interventions

Molnupiravir 400 mg (Drug)
This is an antiviral drug (an RNA dependent RNA polymerase inhibitor, with broad spectrum antiviral activity) currently approved for use in treatment for COVID-19 patients. In this trial, its antiviral effectiveness on the early phase of dengue virus infection will be assessed.
VIS513 (a monoclonal antibody) (Drug)
VIS513 is an engineered humanised monoclonal antibody produced by recombinant DNA technology in a mammalian cell (i.e. Chinese hamster ovary) line. It was discovered in the USA by Visterra Inc and subsequently technology for manufacturing and further development was transferred to Serum Institute of India Pvt. Ltd., Pune, India. It has shown potent, specific neutralization of all four serotypes of DENV.
Remdesivir 100mg (Drug)
Remdesivir (GS-443902) is a nucleoside analogue - RNA dependent RNA polymerase inhibitor.

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.

Conditions

Dengue Antiviral Drugs

Locations

Universiti Malaya Medical Centre — Kuala Lumpur, Malaysia
Hospital for Tropical Diseases, Ho Chi Minh city — Ho Chi Minh City, Vietnam

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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