Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)
NCT ID: NCT06917001
Last Updated: 2025-08-28
Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2026-02-28
2027-12-31
Brief Summary
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Is Resomelagon safe to use in patients with Dengue? Is Resomelagon able to reduce the duration of illness? (defined by clinical and laboratory criteria) Participants will be allocated to Resomelagon or placebo groups in this study and asked to take the medication and submitted to blood tests.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Resomelagon
Resomelagon, 100mg, orally, once daily plus standard treatment
Resomelagon
Resomelagon 100mg, orally, once daily.
Standard Treatment
Hydration and symptomatic therapy as indicated for Dengue fever.
Placebo
Placebo plus standard treatment
Placebo
Placebo
Standard Treatment
Hydration and symptomatic therapy as indicated for Dengue fever.
Interventions
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Resomelagon
Resomelagon 100mg, orally, once daily.
Placebo
Placebo
Standard Treatment
Hydration and symptomatic therapy as indicated for Dengue fever.
Eligibility Criteria
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Inclusion Criteria
* Able to understand study procedures and give informed consent;
* Presents with more than 36 and less than 84h since symptoms onset;
* Symptoms compatible with dengue infection (fever, myalgia, arthralgia, headache or conjunctivitis) with positive antigen test or polymerase chain reaction test.
Exclusion Criteria
* Significant laboratory abnormalities discovered at triage: Hemoglobin \<10g/dL; Platelet count \< 50.000/microL; alanine transaminase \> 3x upper limit of normal; Total bilirubin \>1,5 x upper limit of normal; glomerular filtration rate \< 60mls/min/1,73m2;
* Contraindications or known hypersensitivity to Resomelagon;
* Presents as dengue with warning signs or severe dengue at inclusion;
* Currently participating in another drug clinical trial;
* Clinical evidence of another infection that might explain current symptoms;
* Pregnant women or women actively trying to achieve pregnancy.
18 Years
65 Years
ALL
No
Sponsors
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Instituto Nacional de Ciência e Tecnologia em Dengue (INCT em Dengue)
UNKNOWN
Federal University of Minas Gerais
OTHER
Responsible Party
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Mauro Martins Teixeira
Pricipal Investigator
Principal Investigators
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Mauro M Teixeira, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Minas Gerais
Locations
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Clinical Research Unit
Belo Horizonte, Minas Gerais, Brazil
Centro Integrado de Pesquisa
São José do Rio Preto, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Almeida PRJ, Periard AM, Tana FL, Avila RE, Milhorato LB, Alcantara KMM, Resende CB, Serufo AV, Santos FR, Teixeira DC, Queiroz-Junior CM, Fonseca TCM, Silva BLV, Costa VV, Souza RP, Perretti M, Jonassen TEN, Teixeira MM. Effects of a pro-resolving drug in COVID-19: preclinical studies to a randomized, placebo-controlled, phase Ib/IIa trial in hospitalized patients. Br J Pharmacol. 2024 Dec;181(23):4750-4765. doi: 10.1111/bph.17322. Epub 2024 Aug 19.
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Dengue Alliance. Electronic address: [email protected]; Dengue Alliance. Treatments for dengue: a Global Dengue Alliance to address unmet needs. Lancet Glob Health. 2023 Nov;11(11):e1680-e1681. doi: 10.1016/S2214-109X(23)00362-5. Epub 2023 Aug 31. No abstract available.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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85788125.5.1001.5415
Identifier Type: -
Identifier Source: org_study_id
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