Associated organisationsCentro de Atención y Diagnóstico de Enfermedades Infecciosas · Nanyang Technological University · National University of Singapore · Oxford Clinical Research Unit - Vietnam · Oxford University Clinical Research Unit - Vietnam · University of OxfordEurope PMC affiliations are not treated as award recipients or mapped locations.
Funding£8.7M
PeriodOct 2025 — Mar 2031
In plain English
AI plain-English summary
Every year, more than 100 million people worldwide develop symptomatic dengue, yet no treatment exists to stop the infection from turning fatal. This trial will test whether three existing drugs—baricitinib, corticosteroids, and N-acetylcysteine—can prevent that progression in hospitalised patients over five years old with moderate or severe dengue. The core problem is that dengue often kills through hyperinflammation and multi-organ failure, not the virus itself, so the trial targets the body’s damaging immune response rather than the pathogen. Between 7,500 and 8,500 participants across multiple countries will be randomly assigned to receive one or more of the drugs or a placebo, with adaptive stopping rules built in to halt the trial early if a treatment clearly works or fails. If any of these drugs prove effective, the impact would be immediate and practical: hospitals in dengue-endemic regions, which are routinely overwhelmed during rainy season outbreaks, would gain a cheap, off-the-shelf therapeutic to reduce deaths and shorten hospital stays. This is not fundamental science—it is a direct test of whether repurposed drugs can save lives now.
View original technical description
Dengue is the most abundant and rapidly spreading arboviral infection globally, with more than 100 million estimated symptomatic infections per year. In endemic countries, dengue is a leading cause of hospital admission during rainy season, and outbreaks can rapidly overwhelm healthcare facilities. Despite this, there are no licensed antiviral or host-directed treatments to prevent progression to severe disease or death, which is often caused by multi-organ failure in the context of hyperinflammation. We plan to conduct a multi-site, multi-country, randomised, placebo-controlled clinical trial to evaluate host-directed and adjuvant therapeutic agents for patients over 5 years of age who are hospitalised with moderate or severe dengue virus infection.Within the trial, we will evaluate the safety and efficacy of immunomodulation with baricitinib and/or corticosteroids. The primary endpoint is a composite outcome of progression to severe dengue and all-cause mortality within 30 days. We will also evaluate the safety and efficacy of N-acetylcysteine to improve liver impairment in a sub-group of patients with moderate or severe dengue-induced liver injury. Randomisation will be factorial and the total sample size will be adaptive (estimated 7500-8500 participants), with multiple planned interim analyses and stopping rules for success.
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