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

ConditionDengue Fever
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFederal University of Minas Gerais

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Resomelagon
  • Placebo
  • Standard Treatment

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Federal University of Minas Gerais

Lead sponsor

Instituto Nacional de Ciência e Tecnologia em Dengue (INCT em Dengue)

Collaborator