Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06917001

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dengue Fever Arbovirus Infections Dengue Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Unit, Belo Horizonte, Minas Gerais, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resomelagon

Drug

Resomelagon 100mg, orally, once daily.

Placebo

Drug

Placebo

standard treatment

Other

Hydration and symptomatic therapy as indicated for Dengue fever.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Efficacy of Resomelagon in reducing illness Severity

    Time frame: 10 days

    Incidence of dengue with warning signs or severe dengue in the study patients

  2. 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

  3. 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

Other outcomes

  1. 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).

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pedro RJ Almeida, MD MSc

CONTACT

[email protected]

+5531995166160

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RESOVIR-2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.