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Not Yet Recruiting NCT05611710

Anakinra in Dengue With Hyperinflammation ( AnaDen )

Conditions: Dengue, Dengue With Warning Signs, Severe Dengue, Anakinra, Immuno-suppressants, Anti-inflammatory Agents, Macrophage Activated Syndrome, Hyperinflammatory Syndrome, Cytokine Storm

Sex: All
Ages: 12 Years – N/A
Phase: PHASE2
Enrollment: 160
Sponsor: Oxford University Clinical Research Unit, Vietnam

Location: Vietnam

Summary

This study aims to evaluate the effect of anakinra in dengue patients with hyperinflammation as compared to placeboPrimary 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 hyperinflammationTo assess the effect of anakinra therapy in patients with dengue on physiological, clinical and virological parametersTo assess the immunomodulation effects of anakinra in dengueImmune cell signatures in dengue with and without anakinraTo assess difference in gene expression between treatment group compared to non-treatment population

Eligibility Criteria

Inclusion Criteria:Patients hospitalised with a clinical diagnosis of dengue and at least 1 warning sign(s) (see appendix) or severe dengue to Emergency department/inpatient wards/Intensive Care wards (ICU),Ferritin levels > 2000ng/mL≥ 12 years of ageWritten informed consent or assent to participate in the studyAgree to come back for 2 follow up visits around day 30 of illness (maximum 5 weeks) and at 3 monthsExclusion Criteria:PregnancyLocalizing features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsisPatients taking immunosuppressive drugs or other biologics in last 1 monthPatients with underlying malignancy or immunosuppressionChildren <12 yearsHave end-stage renal failure (baseline GFR < 30ml/min)Being treated for TBTaking any drug with significant interaction with anakinraThe study physician judges that the patient is unlikely to attend follow up visit at around 3-4 weeks after fever onset - e.g. due to long travelling distance from the clinic

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05611710). StuddyBuddy aggregates publicly available trial information.