Journal article
Anakinra for dengue patients with hyperinflammation: protocol for a randomized double-blind placebo-controlled trial
- Abstract:
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Background
Novel host-directed therapies are urgently needed for patients with dengue, particularly those at high risk of developing severe disease. Broad immunosuppression using corticosteroids in unselected patients with dengue has so far been unsuccessful. Patients with hyperinflammation (raised CRP and/or ferritin levels) are at highest risk of poor outcomes in dengue. Anakinra is a licensed, bio-engineered form of the naturally occurring IL-1R antagonist which has shown efficacy in other acute viral-associated hyperinflammatory syndromes.
Methods
This is a randomized placebo-controlled phase II trial of anakinra in 160 patients ≥ 12 years old, diagnosed as having dengue with warning signs or severe dengue and the hyperinflammatory syndrome (plasma ferritin >2000 ng/ml). Participants will receive a 4-day course of either anakinra or placebo. The primary endpoint is the efficacy of anakinra measured by the delta mSOFA score* (change in mSOFA score over 4 days after randomization). The accompanying immunological and transcriptomic analyses aim to identify novel mechanisms and pathways that may represent future biomarkers and therapeutic targets.
Discussion
The observed immunomodulatory benefit of anakinra in acute viral-associated hyperinflammatory syndromes including COVID-19 and auto-immune diseases makes this medication a promising potential treatment for dengue patients with hyperinflammation. This trial will assess the safety and efficacy of anakinra in patients with severe dengue or at high risk of developing life-threatening dengue disease.
Registration
ClinicalTrials.gov (NCT05611710).
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 1.1MB, Terms of use)
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- Publisher copy:
- 10.12688/wellcomeopenres.21017.1
Authors
- Publisher:
- Taylor and Francis
- Journal:
- Wellcome Open Research More from this journal
- Volume:
- 9
- Article number:
- 689
- Publication date:
- 2024-11-22
- Acceptance date:
- 2024-12-20
- DOI:
- EISSN:
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2398-502X
- Pmid:
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39931105
- Language:
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English
- Keywords:
- Pubs id:
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2085303
- Local pid:
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pubs:2085303
- Deposit date:
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2025-05-22
- ARK identifier:
Terms of use
- Copyright holder:
- Huyen TB et al.
- Copyright date:
- 2024
- Rights statement:
- © 2024 Huyen TB et al. This is an open access work distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
- Licence:
- CC Attribution (CC BY)
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