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Anakinra in Dengue With Hyperinflammation ( AnaDen )

NCT05611710 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-06

No results posted yet for this study

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

Conditions

  • Dengue
  • Dengue With Warning Signs
  • Severe Dengue
  • Anakinra
  • Immuno-modulation
  • Anti-inflammatory Agents
  • Macrophage Activation Syndrome
  • Hyperinflammatory Syndrome
  • Cytokine Storm

Interventions

DRUG

Placebo

Drug: Placebo, with visually matched clear syringes * Adults (≥16 years) and children (12-16 years, \> 50Kg) will receive 2 syringes of placebo via IV route, twice daily for 4 days * Children (12-16 years, \< 50Kg) will receive no more than 1 syringe of placebo via IV route, twice daily for 4 days

DRUG

Anakinra

Drug: Anakinra * Adults (≥16 years) and children (12-16 years, \> 50Kg) will receive 200mg of anakinra (2 syringes) via IV route, twice daily for 4 days * Children (12-16 years, \< 50Kg) will receive 2mg/Kg of anakinra via IV route, twice daily for 4 days (no more than 1 syringe of anakinra, twice daily for 4 days)

Sponsors & Collaborators

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Sophie Yacoub · University of Oxford, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2025-10-20
Completion
2027-12-31

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611710 on ClinicalTrials.gov