Trials / Active Not Recruiting

Active Not RecruitingNCT05611710

Anakinra in Dengue With Hyperinflammation ( AnaDen )

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

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 160 (estimated)

Sponsor: Oxford University Clinical Research Unit, Vietnam · Academic / Other
Sex: All
Age: 12 Years
Healthy volunteers: Not accepted

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

Detailed description

This is a randomized double blinded placebo controlled trial investigating the effects of four days of anakinra treatment on dengue patients with hyperinflammatory syndrome. The anakinra/placebo will be given to eligible participants admitted to the Hospital for Tropical Diseases (HTD) in Ho Chi Minh City, Vietnam. 160 dengue patients will be randomly assigned to either anakinra or placebo intervention group to receive treatment for 4 days. Patients admitted to the HTD with a clinical diagnosis of dengue and at least 1 warning sign(s) or severe dengue to Emergency department / inpatient wards / Intensive Care Units (ICU), will be invited to participate in the trial. Eligible patients will be invited to participate in the screening phase during which, the collection of clinical information about this acute illness episode as well as some screening tests will be performed, including measurement ferritin, creatinine, pregnancy test (for all females). \- If ferritin level is greater than 2000ng/mL and meet all other inclusion/exclusion criteria, patients will be invited to participate in the randomization phase (second consent), which they will be randomly given either anakinra or placebo intravenous (IV) for four days. The intervention: * (i) 200mg bid for four days in adults participants (≥ 16 years) or in children (12-16 years), with weight \> 50kg; and * (ii) 2mg/kg bid for four days in children (12-16 years), with weight \< 50Kg. All patients will be followed up daily at the clinical wards until discharge. Details of all AEs and SAEs will be recorded on specific forms, together with an assessment as to whether the events are likely to have been related to any treatment received. All SAEs will be reported promptly to the DMC and ECs according to policy. In cases of discontinuation due to AEs, participants will be followed up until the events have resolved or stabilized.

Conditions

Interventions

Type	Name	Description
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)

Timeline

Start date: 2023-01-02
Primary completion: 2025-10-20
Completion: 2027-12-31
First posted: 2022-11-10
Last updated: 2026-01-06

Locations

1 site across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT05611710. Inclusion in this directory is not an endorsement.