A Phase 2 interventional study of Placebo and Anakinra in Dengue, Dengue With Warning Signs and Severe Dengue, sponsored by Oxford University Clinical Research Unit, Vietnam. Active, not recruiting at 1 site in Vietnam. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Oxford University Clinical Research Unit, Vietnam · Phase 2, Interventional, and Treatment
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:
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:
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.
65 studies on the registry are indexed under Severe Dengue; 5 are open to participants now.
This study's planned enrollment of 160 is close to the median of 170 across 52 interventional studies indexed under Severe Dengue.
Browse Severe Dengue studies →Oxford University Clinical Research Unit, Vietnam is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Compared within Severe Dengue, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dengue. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will be formed of 80 dengue patients with warning signs or severe dengue receiving placebo.
Drug: Placebo
The intervention group will include 80 dengue patients with warning signs or severe dengue receiving anakinra.
Drug: Anakinra
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 * 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)
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)
Time frame: baseline, up to day 4
Mortality
Number of death up to day 30
Time frame: Up to day 30
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)
Time frame: baseline, day 7
Number of days treated in Intensive care unit (ICU)
Number of days treated in ICU
Time frame: Up to day 30
Number of days treated in hospital
Number of days treated in hospital
Time frame: Up to day 30
Number of participants with Serious Adverse Events (SAEs)
Number of participants having SAEs within 2 time-periods, 1- 5 days and 6-30 days
Time frame: Day 1-5 and Day 6-30
Number of Adverse Events (AEs) per participant
Number of AEs per individual
Time frame: Up to day 30
Change in Platelets count
Change in blood levels (Platelets) over 5 days following randomization and at day 30
Time frame: Up to day 5, at day 30
Change in neutrophils count
Change in blood levels (neutrophils) over 5 days following randomization and at day 30
Time frame: Up to day 5, at day 30
Change of ALT levels
Change in blood levels (ALT) over 5 days following randomization and at day 30
Time frame: Up to day 5, at day 30
Change of Ferritin levels
Change in blood levels (Ferritin) over 5 days following randomization and at day 30
Time frame: Up to day 5, at day 30
Change of CRP levels
Change in blood levels (CRP) over 5 days following randomization and at day 30
Time frame: Up to day 5, at day 30
Time to normalization of blood levels
Time to normalization of platelets (defined as \>150 x109/l) and neutrophils (\>2 x109/l)
Time frame: Up to day 30
Platelet nadir
Lowest platelet count recorded during admission
Time frame: Up to day 30
Fever clearance time
Time to temperature \<37.5 for at least 48 hours
Time frame: Up to day 30
Duration of viraemia
Number of days from enrollment to the first undetectable viraemia (negative in qPCR and NS1)
Time frame: Up to day 30
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
Time frame: at discharge (assessed up to day 8)
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.
Time frame: at discharge (assessed up to day 8) and at day 30
Change in immune cells
Phenotyping CD8/4+T and NK cells will be assessed
Time frame: Up to day 90
Plan to share: Yes — Anonymised data of this study may be requested for publication by journals. Sharing anonymised with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation than authorized in the study.
Supporting information: Study protocol
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Oxford University Clinical Research Unit, Vietnam