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NOT YET RECRUITING
NCT07543458
PHASE3

Therapeutics for Moderate and Severe Dengue

Sponsor: Oxford University Clinical Research Unit, Vietnam

View on ClinicalTrials.gov

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

Interventions

DRUG

Placebo

Placebo matched to baricitinib/dexamethasone in form, dose, frequency and duration.

DRUG

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.

DRUG

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.

OTHER

Standard of care

Standard of care as per local site guidelines

DRUG

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