Therapeutics for Moderate and Severe Dengue

Sponsor
Oxford University Clinical Research Unit, Vietnam
Study ID
NCT07543458
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Arbovirus Infections
  • Dengue
  • Flavivirus Infections
  • Hemorrhagic Fever
  • Mosquito-Borne Diseases
  • RNA Virus Infections
  • Severe Dengue
  • Vector Borne Diseases

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo matched to baricitinib/dexamethasone in form, dose, frequency and duration.
  • Dexamethasone — DRUG
    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 — DRUG
    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 — OTHER
    Standard of care as per local site guidelines
  • Baricitinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
8,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Comparison A: Baricitinib versus placebo
    Participants eligible for baricitinib may be randomized to baricitinib or matched placebo.
  • Experimental: Comparison B: Dexamethasone versus Placebo
    Participants eligible for dexamethasone may be randomized to dexamethasone or matched placebo.
  • Experimental: Comparison C: N-acetylcysteine versus standard of care
    Patients with liver involvement (ALT or AST \>400 IU/L) during hospital admission may be randomised to N-acetylcysteine or standard of care.

Primary Outcome Measure

Progression to severe dengue/critical dengue [ Time Frame: between randomization to hospital discharge (average of 5 days) ]

Central Contacts

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