Anakinra in Dengue With Hyperinflammation ( AnaDen )
Key facts
- Who runs it
- Oxford University Clinical Research Unit, Vietnam
- Where
- Vietnam1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 2
- People taking part
- 160 people, planned
- Started
- 2 Jan 2023
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- Anakinra
- Record updated
- 6 January 2026
Who can take part
- Age
- 12 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Patients hospitalised with a clinical diagnosis of dengue and at least 1 warning sign(s) (see appendix) or severe dengue to Emergency department/inpatient wards/Intensive Care wards (ICU),
- Ferritin levels > 2000ng/mL
- ≥ 12 years of age
- Written informed consent or assent to participate in the study
- Agree to come back for 2 follow up visits around day 30 of illness (maximum 5 weeks) and at 3 months
Who cannot take part
- Patients taking immunosuppressive drugs or other biologics in last 1 month
- Taking any drug with significant interaction with anakinra
- Patients with underlying malignancy or immunosuppression
- Have end-stage renal failure (baseline GFR < 30ml/min)
- Children <12 years
- Pregnancy
- Localizing features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis
- Being treated for TB
- The study physician judges that the patient is unlikely to attend follow up visit at around 3-4 weeks after fever onset - e.g. due to long travelling distance from the clinic
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This study aims to evaluate the effect of anakinra in dengue patients with hyperinflammation as compared to placebo
Read full original descriptionShow less
Primary Objective:
To evaluate the efficacy of Anakinra in moderate-severe dengue patients with hyperinflammation.
Secondary Objectives:
* To assess the safety of anakinra therapy in dengue with hyperinflammation * To assess the effect of anakinra therapy in patients with dengue on physiological, clinical and virological parameters * To assess the immunomodulation effects of anakinra in dengue * Immune cell signatures in dengue with and without anakinra * To assess difference in gene expression between treatment group compared to non-treatment population
The 2 groups in the trial
- PlaceboPlacebo, for comparison
The control group will be formed of 80 dengue patients with warning signs or severe dengue receiving placebo.
- AnakinraTreatment being tested
The intervention group will include 80 dengue patients with warning signs or severe dengue receiving anakinra.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Anakinra for Dengue Patients With Hyperinflammation - a Randomized Double-blind Placebo-controlled Trial
- Record updated
- 6 January 2026