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Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)

RecruitingPhase 2Ages 18 Years - 65 YearsAllFederal University of Minas Gerais
NCT06917001 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to understand if Resomelagon can treat adult patients with Dengue virus infection. The main questions the investigators aim to answer are: 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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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients who are 18 to 65 years old; * 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: * Has any comorbidity which is perceived as significant by the investigator; * 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.
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What it tests

  • Resomelagon
  • Placebo
  • Standard Treatment
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Where

2 sites
Clinical Research Unit
Belo Horizonte, Brazil
Centro Integrado de Pesquisa
São José do Rio Preto, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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