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

August 27, 2025 updated by: Mauro Martins Teixeira, Federal University of Minas Gerais

A Randomized, Double-blind, Placebo-controled, Phase 2a Trial Evaluating the Safety and Initial Efficacy of Resomelagon in Patients With Dengue Infection

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30750140
        • Clinical Research Unit
        • Contact:
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090000
        • Centro Integrado de Pesquisa
        • Contact:
        • Principal Investigator:
          • Cassia F Estofolete, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resomelagon
Resomelagon, 100mg, orally, once daily plus standard treatment
Drug: Resomelagon
Resomelagon 100mg, orally, once daily.
Other: Standard Treatment
Hydration and symptomatic therapy as indicated for Dengue fever.
Placebo Comparator: Placebo
Placebo plus standard treatment
Drug: Placebo
Placebo
Other: Standard Treatment
Hydration and symptomatic therapy as indicated for Dengue fever.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate safety of Resomelagon in Dengue patients
Time Frame: 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.
28 days
Efficacy of Resomelagon in decreasing illness duration
Time Frame: 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.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Resomelagon in reducing illness Severity
Time Frame: 10 days
Incidence of dengue with warning signs or severe dengue in the study patients
10 days
Efficacy of Resomelagon in reducing plasma leakage
Time Frame: 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
10 days
Efficacy of Resomelagon in reducing dengue hospitalization or prolonged observation in the Emergency department
Time Frame: 10 days
Incidence of a stay of more than 12h in the emergency department or hospital admission
10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of proinflammatory cytokines.
Time Frame: 28 days
Measurement of proinflammatory cytokines using Meso Scale Discovery (MSD) platform with V-Plex proinflammatory panel 1 (Human).
28 days
Evaluation of proinflammatory chemokines.
Time Frame: 28 days
Measurement of proinflammatory chemokines using Meso Scale Discovery (MSD) platform with V-Plex Chemokine Panel 1 (Human).
28 days
Evaluation of cytokine production by mononuclear cells.
Time Frame: 28 days
Mononuclear cells from peripheral blood will be evaluated by flow cytometry for assessment of their surface inflammatory biomarkers.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

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

Investigators

  • Principal Investigator: Mauro M Teixeira, MD PhD, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85788125.5.1001.5415

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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