Clinical Trial

Anakinra in Dengue With Hyperinflammation ( AnaDen )

Active, Not Recruiting Phase 2
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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
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-11-03; most recent amendment 2025-12-31.
Status change: Recruiting → Active, Not Recruiting 2025-12-31
Status change: Not Yet Recruiting → Recruiting 2024-03-19
Trial Details
NCT Number NCT05611710
Lead Sponsor Oxford University Clinical Research Unit, Vietnam
Collaborators: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Wellcome Trust
Conditions Dengue, Dengue With Warning Signs, Severe Dengue, Anakinra, Immuno-modulation, Anti-inflammatory Agents, Macrophage Activation Syndrome, Hyperinflammatory Syndrome +1 more
Enrollment 160 participants
Start Date 2023-01-02
Primary Completion 2025-10-20 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-06