Evaluating Anakinra for Dengue Patients with Hyperinflammation
Anakinra for Dengue Patients With Hyperinflammation - a Randomized Double-blind Placebo-controlled Trial
This study is testing if the drug anakinra can help people with moderate to severe dengue who have high inflammation feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Oxford University Clinical Research Unit, Vietnam Academic / other |
| Locations | 1 site (Ho Chi Minh) |
| Trial ID | NCT05611710 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of anakinra, an immunomodulatory drug, in patients suffering from moderate to severe dengue with hyperinflammation. The study is a randomized, double-blind, placebo-controlled trial involving 160 participants who will receive either anakinra or a placebo for four days. Patients will be monitored for clinical, physiological, and virological parameters, as well as immune cell signatures and gene expression differences. The trial is conducted at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.
Who should consider this trial
Good fit: Ideal candidates include hospitalized patients aged 12 years and older with a clinical diagnosis of dengue and elevated ferritin levels above 2000ng/mL.
Not a fit: Patients with alternative diagnoses, severe immunosuppression, or those under 12 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for dengue patients experiencing hyperinflammation.
How similar studies have performed: While the use of anakinra in dengue is a novel approach, similar immunomodulatory strategies have shown promise in other hyperinflammatory conditions.
Eligibility criteria
Show full inclusion / exclusion 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 age * Written informed consent or assent to participate in the study * Agree to come back for 2 follow up visits around day 30 of illness (maximum 5 weeks) and at 3 months Exclusion Criteria: * Pregnancy * Localizing features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis * Patients taking immunosuppressive drugs or other biologics in last 1 month * Patients with underlying malignancy or immunosuppression * Children \<12 years * Have end-stage renal failure (baseline GFR \< 30ml/min) * Being treated for TB * Taking any drug with significant interaction with anakinra * The 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
Where this trial is running
Ho Chi Minh
- Hospital for Tropical Diseases — Ho Chi Minh, Vietnam (Recruiting)
Study contacts
- Principal investigator: Sophie Yacoub — University of Oxford, UK
- Study coordinator: Sophie Yacoub
- Email: syacoub@oucru.org
- Phone: +84 77728736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.