Can an arthritis drug tame deadly dengue inflammation?

NCT ID NCT05611710

Disease control Sponsor: Oxford University Clinical Research Unit, Vietnam Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether anakinra, an anti-inflammatory drug, can help people with severe dengue who have dangerously high inflammation. About 160 adults and children will receive either anakinra or a placebo for four days. The goal is to see if anakinra reduces organ failure and improves recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Anakinra (an anti-inflammatory drug given intravenously)
What this could lead to: If it works, this could offer a way to prevent organ failure in severe dengue patients with dangerous inflammation.
What could go wrong: This is a mid-stage trial with only 160 participants, so results may not apply to all dengue patients. Anakinra may not improve outcomes and could have side effects like increased infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cytokine release syndrome dengue disease Dengue hemorrhagic fever dengue shock syndrome hemophagocytic syndrome macrophage activation syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anakinra Anti-inflammatory agents Cytokine storm Dengue Dengue with warning signs Hyperinflammatory syndrome Immuno-modulation Macrophage activation syndrome Severe dengue

Can an arthritis drug tame deadly dengue inflammation?

What the study statuses mean