Resomelagon in Dengue Infection: Safety and Function in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial evaluating the safety and efficacy of Resomelagon in adults with acute dengue infection. Participants aged 18–65 with dengue-like symptoms within 36–84 hours of onset and a positive diagnostic test are assigned to receive Resomelagon, placebo, or standard treatment. The study monitors safety and clinical/laboratory outcomes to determine if Resomelagon reduces illness duration and inflammatory responses. Preclinical data suggest anti-inflammatory and pro-resolving effects may limit vascular changes and cytokine release associated with dengue. The trial is conducted at sites in Belo Horizonte and São Paulo, Brazil, led by Federal University of Minas Gerais in collaboration with INCT em Dengue.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Research Unit
  Belo Horizonte, Minas Gerais, Brazil Recruiting
• Centro Integrado de Pesquisa
  São José do Rio Preto, São Paulo, Brazil Not yet recruiting

Study contacts

• Principal investigator: Mauro M Teixeira, MD PhD — Federal University of Minas Gerais
• Study coordinator: Pedro RJ Almeida, MD MSc
• Email: pedrojesus@ufmg.br
• Phone: +5531995166160

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.