DenguePhase 2NCT05611710
Anakinra in Dengue With Hyperinflammation ( AnaDen )
A Phase 2 study testing Anakinra in people with Dengue and Dengue With Warning Signs, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dengue, Dengue With Warning Signs, Severe Dengue
- What is being tested?
- Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteVietnam
- Study dates
- 2 Jan 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Dengue, Dengue With Warning Signs, Severe Dengue, Anakinra, Immuno-modulation, Anti-inflammatory Agents
- Being tested
- Placebo, Anakinra
- Keywords
- Dengue, Hyperinflammatory syndrome, Anakinra, Vietnam
- Medical subject headings
- Dengue, Severe Dengue, Macrophage Activation Syndrome, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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
AnakinraDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The control group will be formed of 80 dengue patients with warning signs or severe dengue receiving placebo. Receives: Drug: Placebo |
| Anakinra | Experimental | The intervention group will include 80 dengue patients with warning signs or severe dengue receiving anakinra. Receives: Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, up to day 4
Secondary outcomes (17)
Mortality
Number of death up to day 30
Measured: 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)
Measured: baseline, day 7
Number of days treated in Intensive care unit (ICU)
Number of days treated in ICU
Measured: Up to day 30
Number of days treated in hospital
Number of days treated in hospital
Measured: 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
Measured: Day 1-5 and Day 6-30
Number of Adverse Events (AEs) per participant
Number of AEs per individual
Measured: Up to day 30
Change in Platelets count
Change in blood levels (Platelets) over 5 days following randomization and at day 30
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Up to day 30
Platelet nadir
Lowest platelet count recorded during admission
Measured: Up to day 30
Fever clearance time
Time to temperature <37.5 for at least 48 hours
Measured: Up to day 30
Duration of viraemia
Number of days from enrollment to the first undetectable viraemia (negative in qPCR and NS1)
Measured: 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
Measured: 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.
Measured: at discharge (assessed up to day 8) and at day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start2 Jan 2023
- Primary completion20 Oct 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a randomized, double blinded, placebo controlled trial of anakinra in patients with dengue with warning signs or severe dengue
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Sophie Yacoub, Principal investigator, University of Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611710
- Sponsor's protocol ID
- 60DX
- Other IDs
- 223004/Z/21/Z
- Status last verified
- Dec 2025
- First submitted
- 19 Oct 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
PubMed 23563266Simmons CP, Farrar JJ, Nguyen vV, Wills B. Dengue. N Engl J Med. 2012 Apr 12;366(15):1423-32. doi: 10.1056/NEJMra1110265. No abstract available.
PubMed 22494122Yacoub S, Wills B. Predicting outcome from dengue. BMC Med. 2014 Sep 4;12:147. doi: 10.1186/s12916-014-0147-9.
PubMed 25259615Whitehorn J, Yacoub S, Anders KL, Macareo LR, Cassetti MC, Nguyen Van VC, Shi PY, Wills B, Simmons CP. Dengue therapeutics, chemoprophylaxis, and allied tools: state of the art and future directions. PLoS Negl Trop Dis. 2014 Aug 28;8(8):e3025. doi: 10.1371/journal.pntd.0003025. eCollection 2014 Aug.
PubMed 25166493Tam DT, Ngoc TV, Tien NT, Kieu NT, Thuy TT, Thanh LT, Tam CT, Truong NT, Dung NT, Qui PT, Hien TT, Farrar JJ, Simmons CP, Wolbers M, Wills BA. Effects of short-course oral corticosteroid therapy in early dengue infection in Vietnamese patients: a randomized, placebo-controlled trial. Clin Infect Dis. 2012 Nov;55(9):1216-24. doi: 10.1093/cid/cis655. Epub 2012 Aug 3.
PubMed 22865871McBride A, Mehta P, Rivino L, Ramanan AV, Yacoub S. Targeting hyperinflammation in infection: can we harness the COVID-19 therapeutics momentum to end the dengue drugs drought? Lancet Microbe. 2021 Jul;2(7):e277-e278. doi: 10.1016/S2666-5247(21)00087-2. Epub 2021 Apr 20. No abstract available.
PubMed 33899037Dinarello CA. The IL-1 family and inflammatory diseases. Clin Exp Rheumatol. 2002 Sep-Oct;20(5 Suppl 27):S1-13.
PubMed 14989423van de Weg CA, Huits RM, Pannuti CS, Brouns RM, van den Berg RW, van den Ham HJ, Martina BE, Osterhaus AD, Netea MG, Meijers JC, van Gorp EC, Kallas EG. Hyperferritinaemia in dengue virus infected patients is associated with immune activation and coagulation disturbances. PLoS Negl Trop Dis. 2014 Oct 9;8(10):e3214. doi: 10.1371/journal.pntd.0003214. eCollection 2014 Oct.
PubMed 25299654Slaats J, Ten Oever J, van de Veerdonk FL, Netea MG. IL-1beta/IL-6/CRP and IL-18/ferritin: Distinct Inflammatory Programs in Infections. PLoS Pathog. 2016 Dec 15;12(12):e1005973. doi: 10.1371/journal.ppat.1005973. eCollection 2016 Dec.
PubMed 27977798Soundravally R, Agieshkumar B, Daisy M, Sherin J, Cleetus CC. Ferritin levels predict severe dengue. Infection. 2015 Feb;43(1):13-9. doi: 10.1007/s15010-014-0683-4. Epub 2014 Oct 30.
PubMed 25354733Cavalli G, Larcher A, Tomelleri A, Campochiaro C, Della-Torre E, De Luca G, Farina N, Boffini N, Ruggeri A, Poli A, Scarpellini P, Rovere-Querini P, Tresoldi M, Salonia A, Montorsi F, Landoni G, Castagna A, Ciceri F, Zangrillo A, Dagna L. Interleukin-1 and interleukin-6 inhibition compared with standard management in patients with COVID-19 and hyperinflammation: a cohort study. Lancet Rheumatol. 2021 Apr;3(4):e253-e261. doi: 10.1016/S2665-9913(21)00012-6. Epub 2021 Feb 3.
PubMed 33655218Kyriakoulis KG, Kollias A, Poulakou G, Kyriakoulis IG, Trontzas IP, Charpidou A, Syrigos K. The Effect of Anakinra in Hospitalized Patients with COVID-19: An Updated Systematic Review and Meta-Analysis. J Clin Med. 2021 Sep 28;10(19):4462. doi: 10.3390/jcm10194462.
PubMed 34640480Rich C, Eriksson D, Dolfi F, Jablonska K, Dabbous F, Nazir J. Patients diagnosed with COVID-19 and treated with anakinra: a real-world study in the USA. Clin Exp Immunol. 2022 Apr 4;207(2):218-226. doi: 10.1093/cei/uxab024.
PubMed 35020840European Medicines Agency. Kineret 2022 [updated 22DEC2021. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/kineret
Kanitkar T, Richardson C, Scobie A, Ireson A, Singh A, Jacobs M, et al. Fatal primary dengue-induced haemophagocytis lymphohistiocytosis (HLH) in a returning traveller from India treated with anakinra for the first time. Clinical Infection in Practice. 2020;7-8
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anakinra for Dengue Patients With Hyperinflammation - a Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05611710
- Acronym / sponsor ID
- 60DX
- Conditions
- Dengue, Dengue With Warning Signs, Severe Dengue, Anakinra, Immuno-modulation, Anti-inflammatory Agents
- Keywords
- Dengue, Hyperinflammatory syndrome, Anakinra, Vietnam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Wellcome Trust
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, double blinded, placebo controlled trial of anakinra in patients with dengue with warning signs or severe dengue
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe control group will be formed of 80 dengue patients with warning signs or severe dengue receiving placebo. |
| Anakinra | Experimental | Drug: AnakinraThe intervention group will include 80 dengue patients with warning signs or severe dengue receiving anakinra. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDrug: 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 | Placebo |
| AnakinraDrug: 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) | Drug | Anakinra |
Primary outcome
Change in modified Sequential Organ Failure Assessment score (mSOFA core, modified for limited resource settings and dengue) within 4 days
Time frame: baseline, up to day 4
Change in mSOFA score over 4 days after randomization (min score= 0, max score = 24, higher scores mean worse outcomes)
17 secondary outcomes
Mortality
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
Time frame: baseline, day 7
Number of days treated in Intensive care unit (ICU)
Time frame: Up to day 30
Number of days treated in hospital
Time frame: Up to day 30
Number of participants with Serious Adverse Events (SAEs)
Time frame: Day 1-5 and Day 6-30
Number of Adverse Events (AEs) per participant
Time frame: Up to day 30
Change in Platelets count
Time frame: Up to day 5, at day 30
Change in neutrophils count
Time frame: Up to day 5, at day 30
Change of ALT levels
Time frame: Up to day 5, at day 30
Change of Ferritin levels
Time frame: Up to day 5, at day 30
Change of CRP levels
Time frame: Up to day 5, at day 30
Time to normalization of blood levels
Time frame: Up to day 30
Platelet nadir
Time frame: Up to day 30
Fever clearance time
Time frame: Up to day 30
Duration of viraemia
Time frame: Up to day 30
Area under the curve (AUC) of the serial viral load measurements during hospital stay
Time frame: at discharge (assessed up to day 8)
Patients' quality of life questionnaire score
Time frame: at discharge (assessed up to day 8) and at day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 23563266Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
- Background: PubMed 22494122Simmons CP, Farrar JJ, Nguyen vV, Wills B. Dengue. N Engl J Med. 2012 Apr 12;366(15):1423-32. doi: 10.1056/NEJMra1110265. No abstract available.
- Background: PubMed 25259615Yacoub S, Wills B. Predicting outcome from dengue. BMC Med. 2014 Sep 4;12:147. doi: 10.1186/s12916-014-0147-9.
- Background: PubMed 25166493Whitehorn J, Yacoub S, Anders KL, Macareo LR, Cassetti MC, Nguyen Van VC, Shi PY, Wills B, Simmons CP. Dengue therapeutics, chemoprophylaxis, and allied tools: state of the art and future directions. PLoS Negl Trop Dis. 2014 Aug 28;8(8):e3025. doi: 10.1371/journal.pntd.0003025. eCollection 2014 Aug.
- Background: PubMed 22865871Tam DT, Ngoc TV, Tien NT, Kieu NT, Thuy TT, Thanh LT, Tam CT, Truong NT, Dung NT, Qui PT, Hien TT, Farrar JJ, Simmons CP, Wolbers M, Wills BA. Effects of short-course oral corticosteroid therapy in early dengue infection in Vietnamese patients: a randomized, placebo-controlled trial. Clin Infect Dis. 2012 Nov;55(9):1216-24. doi: 10.1093/cid/cis655. Epub 2012 Aug 3.
- Background: PubMed 33899037McBride A, Mehta P, Rivino L, Ramanan AV, Yacoub S. Targeting hyperinflammation in infection: can we harness the COVID-19 therapeutics momentum to end the dengue drugs drought? Lancet Microbe. 2021 Jul;2(7):e277-e278. doi: 10.1016/S2666-5247(21)00087-2. Epub 2021 Apr 20. No abstract available.
- Background: PubMed 14989423Dinarello CA. The IL-1 family and inflammatory diseases. Clin Exp Rheumatol. 2002 Sep-Oct;20(5 Suppl 27):S1-13.
- Background: PubMed 25299654van de Weg CA, Huits RM, Pannuti CS, Brouns RM, van den Berg RW, van den Ham HJ, Martina BE, Osterhaus AD, Netea MG, Meijers JC, van Gorp EC, Kallas EG. Hyperferritinaemia in dengue virus infected patients is associated with immune activation and coagulation disturbances. PLoS Negl Trop Dis. 2014 Oct 9;8(10):e3214. doi: 10.1371/journal.pntd.0003214. eCollection 2014 Oct.
- Background: PubMed 27977798Slaats J, Ten Oever J, van de Veerdonk FL, Netea MG. IL-1beta/IL-6/CRP and IL-18/ferritin: Distinct Inflammatory Programs in Infections. PLoS Pathog. 2016 Dec 15;12(12):e1005973. doi: 10.1371/journal.ppat.1005973. eCollection 2016 Dec.
- Background: PubMed 25354733Soundravally R, Agieshkumar B, Daisy M, Sherin J, Cleetus CC. Ferritin levels predict severe dengue. Infection. 2015 Feb;43(1):13-9. doi: 10.1007/s15010-014-0683-4. Epub 2014 Oct 30.
- Background: PubMed 33655218Cavalli G, Larcher A, Tomelleri A, Campochiaro C, Della-Torre E, De Luca G, Farina N, Boffini N, Ruggeri A, Poli A, Scarpellini P, Rovere-Querini P, Tresoldi M, Salonia A, Montorsi F, Landoni G, Castagna A, Ciceri F, Zangrillo A, Dagna L. Interleukin-1 and interleukin-6 inhibition compared with standard management in patients with COVID-19 and hyperinflammation: a cohort study. Lancet Rheumatol. 2021 Apr;3(4):e253-e261. doi: 10.1016/S2665-9913(21)00012-6. Epub 2021 Feb 3.
- Background: PubMed 34640480Kyriakoulis KG, Kollias A, Poulakou G, Kyriakoulis IG, Trontzas IP, Charpidou A, Syrigos K. The Effect of Anakinra in Hospitalized Patients with COVID-19: An Updated Systematic Review and Meta-Analysis. J Clin Med. 2021 Sep 28;10(19):4462. doi: 10.3390/jcm10194462.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Yacoub principal investigator
University of Oxford, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra in people with Dengue and Dengue With Warning Signs, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified Sequential Organ Failure Assessment score (mSOFA core, modified for limited resource settings and dengue) within 4 days (time frame: baseline, up to day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611710, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.