Adaptive platform testing antiviral medicines and a monoclonal antibody for early dengue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital for Tropical Diseases, Ho Chi Minh city
  Ho Chi Minh City, Vietnam Recruiting
• Universiti Malaya Medical Centre
  Kuala Lumpur, Malaysia Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.