Anakinra in Dengue With Hyperinflammation ( AnaDen )

• Status: Not yet recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the effect of anakinra in dengue patients with hyperinflammation as compared to placebo

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford University Clinical Research Unit, Vietnam
• Collaborator: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy

• Localizing features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis

• Patients taking immunosuppressive drugs or other biologics in last 1 month

• Patients with underlying malignancy or immunosuppression

• Children <12 years

• Have end-stage renal failure (baseline GFR < 30ml/min)

• Being treated for TB

• Taking any drug with significant interaction with anakinra

• 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