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Therapeutics for Moderate and Severe Dengue
Sponsor: Oxford University Clinical Research Unit, Vietnam
Summary
The purpose of this multi-site, factorial randomised, platform trial is to evaluate host-directed therapeutic agents in patients hospitalised with moderate and severe dengue virus infection. Our primary aim is to find safe and affordable therapeutics which prevent disease progression among those at high risk for severe dengue, and improve outcomes for those with established severe disease, thereby also reducing the substantial burden placed on health systems in dengue endemic regions.
Official title: A Randomised Platform Trial to Evaluate Therapeutics in Patients With Moderate or Severe Dengue (DEN-HOST)
Key Details
Gender
All
Age Range
5 Years - Any
Study Type
INTERVENTIONAL
Enrollment
8800
Start Date
2026-10-01
Completion Date
2031-07-31
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo matched to baricitinib/dexamethasone in form, dose, frequency and duration.
Dexamethasone
Dexamethasone is a corticosteroid. Form: tablet or intravenous preparation. Dose: Aged ≥ 12 years: 6mg once daily. Aged 5 - 11 years by weight: * 10kg to \<20 kg: 2mg once daily, * 20kg to \<30 kg: 4mg once daily, * 30kg: 6mg once daily. Duration: 4 days, or until discharge if this happens before.
N-Acetylcysteine
N-acetylcysteine acts to protect the liver. It functions as a glutathione precursor and antioxidant. Dose: 100mg/kg/day, by continuous infusion over 24 hours in glucose 5% (preferred) or sodium chloride 0.9%. Duration: 4 days, or until hospital discharge if sooner.
Standard of care
Standard of care as per local site guidelines
Baricitinib
Baricitinib is an inhibitor of Janus Kinase (JAK) 1 \& 2, and Numb associated kinase (NAK). Form: tablet. Dose: Aged ≥ 12 years: 4mg once daily, Aged 5 - 11 years: 2mg once daily. - Renal adjustment of dose: Adults: eGFR ≥30 and \<60 mL/min/1.73m2: 2mg once daily, eGFR ≥15 and \<30 mL/min/1.73m2: 2mg on alternate days. Children: eGFR ≥30 and \<60mL/min/1.73m2: 2mg on alternate days \- Dose should be halved in patients also taking probenecid Duration: 4 days, or less if the patient is discharged before this time.
Locations (18)
Chittagong Medical College Hospital
Chittagong, Bangladesh
Dhaka Medical College & Hospital
Dhaka, Bangladesh
Dhaka North City Corporation Hospital
Dhaka, Bangladesh
Instituto de Infectologia Emílio Ribas
São Paulo, Brazil
Centro de Atención y Diagnóstico de Enfermedades Infecciosas
Bucaramanga, Colombia
Fundación Valle del Lili
Cali, Colombia
Hospital Universitario Erasmo Meoz
Cúcuta, Colombia
Universitas Sumatera Utara
Medan, Indonesia
Hospital Queen Elizabeth II, Sabah
Kota Kinabalu, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
National Academy of Medical Sciences/Bir Hospital
Kathmandu, Nepal
Sukraraj Tropical and Infectious Disease Hospital
Kathmandu, Nepal
Hospital Regional de Loreto
Iquitos, Peru
San Lazaro Hospital
Manila, Philippines
Siriraj Hospital, Mahidol University
Bangkok, Thailand
Prince of Songkla University in Southern Thailand
Songkhla, Thailand
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam
Number 2 Children's Hospital
Ho Chi Minh City, Vietnam