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

Launched by FEDERAL UNIVERSITY OF MINAS GERAIS · Apr 1, 2025

Keywords

ClinConnect Summary

The RESOVIR-2 clinical trial is studying a medication called Resomelagon to see if it can safely and effectively treat adults with Dengue fever, a viral infection that causes symptoms like fever, muscle pain, and headaches. The main goals of the trial are to check if Resomelagon is safe for patients and if it can help reduce how long they are sick. Participants will either receive Resomelagon or a placebo (a dummy treatment) and will need to take the medication and undergo some blood tests during the study.

To be eligible for this trial, participants should be between 18 and 65 years old, able to give consent, and have had symptoms of Dengue for more than 36 hours but less than 84 hours, confirmed by specific tests. However, individuals with certain health issues or severe symptoms, as well as pregnant women, will not be able to participate. The trial is not currently recruiting participants, but it will provide important information on the potential benefits of Resomelagon for treating Dengue fever.

Gender

ALL

Eligibility criteria

• 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.