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

Federal University of Minas Gerais

Status and phase

Not yet enrolling

Phase 2

Conditions

Dengue Fever

Treatments

Drug: Placebo

Other: Standard Treatment

Drug: Resomelagon

Study type

Interventional

Funder types

Other

Identifiers

NCT06917001

85788125.5.1001.5415

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.