Status:
NOT_YET_RECRUITING
Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)
Lead Sponsor:
Federal University of Minas Gerais
Collaborating Sponsors:
Instituto Nacional de Ciência e Tecnologia em Dengue (INCT em Dengue)
Conditions:
Dengue Fever
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 us...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06917001
Start Date
February 1 2026
End Date
December 1 2027
Last Update
August 28 2025
Active Locations (2)
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1
Clinical Research Unit
Belo Horizonte, Minas Gerais, Brazil, 30750140
2
Centro Integrado de Pesquisa
São José do Rio Preto, São Paulo, Brazil, 15090000