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

Phase 2

Not yet recruiting

• Conditions: Dengue Fever
• Interventions: Drug: Resomelagon; Drug: Placebo; Other: Standard Treatment

• Registration Number: NCT06917001
• Lead Sponsor: Federal University of Minas Gerais

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resomelagon	Resomelagon	Resomelagon, 100mg, orally, once daily plus standard treatment
Resomelagon	Standard Treatment	Resomelagon, 100mg, orally, once daily plus standard treatment
Placebo	Placebo	Placebo plus standard treatment
Placebo	Standard Treatment	Placebo plus standard treatment

Primary Outcome Measures

Name	Time	Method
Evaluate safety of Resomelagon in Dengue patients	28 days	Incidence of clinical or laboratory adverse events. All symptoms, illness and laboratory abnormalities will be graded by the investigators in accordance to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events graded 3 or more in severity will be registered. Serious adverse events will be reported and registered. Incidence of adverse events will be compared between placebo and intervention groups.
Efficacy of Resomelagon in decreasing illness duration	10 days	Time to resolution of illness as defined by a composite outcome: Patient afebrile for 48 hours without paracetamol (or other drugs to treat fever) ingestion; Rising platelet counts of \>20% of the lowest, or normal platelet counts if the patient did not have thrombocytopenia, following two consecutive measurements from the lowest platelet count Haematocrit stabilized or return to the normal hematocrit for age \& sex, following two consecutive measurements Absence of bleeding or significant vomiting for 48h.

Secondary Outcome Measures

Name	Time	Method
Efficacy of Resomelagon in reducing illness Severity	10 days	Incidence of dengue with warning signs or severe dengue in the study patients
Efficacy of Resomelagon in reducing plasma leakage	10 days	Incidence of hemoconcentration (hematocrit increase of \>10% from inclusion or elevated for age \& sex) OR evidence of pleural effusion OR evidence of ascitis OR pericardial effusion
Efficacy of Resomelagon in reducing dengue hospitalization or prolonged observation in the Emergency department	10 days	Incidence of a stay of more than 12h in the emergency department or hospital admission

Trial Locations

Locations (2)

Clinical Research Unit; 🇧🇷 Belo Horizonte, MG, Brazil

Centro Integrado de Pesquisa; 🇧🇷 São José do Rio Preto, São Paulo, Brazil