Dengue Clinical Trial
Official title:
Anakinra for Dengue Patients With Hyperinflammation - a Randomized Double-blind Placebo-controlled Trial
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
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | Hospital for Tropical Diseases | Ho Chi Minh |
Lead Sponsor | Collaborator |
---|---|
Oxford University Clinical Research Unit, Vietnam | Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam |
Vietnam,
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* Note: There are 39 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in immune cells | Phenotyping CD8/4+T and NK cells will be assessed | Up to day 90 | |
Primary | Change in modified Sequential Organ Failure Assessment score (mSOFA core, modified for limited resource settings and dengue) within 4 days | Change in mSOFA score over 4 days after randomization (min score= 0, max score = 24, higher scores mean worse outcomes) | baseline, up to day 4 | |
Secondary | Mortality | Number of death up to day 30 | Up to day 30 | |
Secondary | Change in modified Sequential Organ Failure Assessment score (mSOFA core, modified for limited resource settings and dengue) at day 7 | Change in mSOFA score at day 7 post randomization (min score= 0, max score = 24, higher scores mean worse outcomes) | baseline, day 7 | |
Secondary | Number of days treated in Intensive care unit (ICU) | Number of days treated in ICU | Up to day 30 | |
Secondary | Number of days treated in hospital | Number of days treated in hospital | Up to day 30 | |
Secondary | Number of participants with Serious Adverse Events (SAEs) | Number of participants having SAEs within 2 time-periods, 1- 5 days and 6-30 days | Day 1-5 and Day 6-30 | |
Secondary | Number of Adverse Events (AEs) per participant | Number of AEs per individual | Up to day 30 | |
Secondary | Change in Platelets count | Change in blood levels (Platelets) over 5 days following randomization and at day 30 | Up to day 5, at day 30 | |
Secondary | Change in neutrophils count | Change in blood levels (neutrophils) over 5 days following randomization and at day 30 | Up to day 5, at day 30 | |
Secondary | Change of ALT levels | Change in blood levels (ALT) over 5 days following randomization and at day 30 | Up to day 5, at day 30 | |
Secondary | Change of Ferritin levels | Change in blood levels (Ferritin) over 5 days following randomization and at day 30 | Up to day 5, at day 30 | |
Secondary | Change of CRP levels | Change in blood levels (CRP) over 5 days following randomization and at day 30 | Up to day 5, at day 30 | |
Secondary | Time to normalization of blood levels | Time to normalization of platelets (defined as >150 x109/l) and neutrophils (>2 x109/l) | Up to day 30 | |
Secondary | Platelet nadir | Lowest platelet count recorded during admission | Up to day 30 | |
Secondary | Fever clearance time | Time to temperature <37.5 for at least 48 hours | Up to day 30 | |
Secondary | Duration of viraemia | Number of days from enrollment to the first undetectable viraemia (negative in qPCR and NS1) | Up to day 30 | |
Secondary | Area under the curve (AUC) of the serial viral load measurements during hospital stay | AUC of viral load measurements during hospital stay will be reported | at discharge (assessed up to day 8) | |
Secondary | Patients' quality of life questionnaire score | Patients' quality of life during their hospitalisation will be explored at discharge and day 30 using the EQ-5D questionnaire. | at discharge (assessed up to day 8) and at day 30 |
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