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Anakinra in Dengue With Hyperinflammation ( AnaDen )

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 31, 2025 to Oct 20, 2025
    • Site details revised
    v7
  2. Collaborators: 1 to 2v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 30, 2023 to Jan 2, 2023
    • Site details revised
    v5
  4. Start date: Sep 30, 2023 to Dec 30, 2023v4
  5. Start date: Jun 30, 2023 to Sep 30, 2023v3
  6. Start date: Dec 31, 2022 to Jun 30, 2023
    • Study description shortened, about 300 words
    • Publications: 1 to 40
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
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
(from sponsor)		 Dengue, Dengue With Warning Signs, Severe Dengue, Anakinra, Immuno-modulation, Anti-inflammatory Agents, Macrophage Activation Syndrome, Hyperinflammatory Syndrome +1 more
Related terms Cytokine Release Syndrome, Dengue, Macrophage Activation Syndrome, Severe Dengue
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov