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ACTIVE NOT RECRUITING
NCT05611710
PHASE2

Anakinra in Dengue With Hyperinflammation ( AnaDen )

Sponsor: Oxford University Clinical Research Unit, Vietnam

View on ClinicalTrials.gov

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

Official title: Anakinra for Dengue Patients With Hyperinflammation - a Randomized Double-blind Placebo-controlled Trial

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2023-01-02

Completion Date

2027-12-31

Last Updated

2026-01-06

Healthy Volunteers

No

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)

Locations (1)

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam