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Adaptive Dengue Antiviral Platform Trial

RecruitingPhase 2Ages 10 Years - anyAllOxford University Clinical Research Unit, Vietnam
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Molnupiravir 400 mg
  • VIS513 (a monoclonal antibody)
  • Remdesivir 100mg
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Where

2 sites
Universiti Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital for Tropical Diseases, Ho Chi Minh city
Ho Chi Minh City, Vietnam
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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