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

NCT06917001 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 85788125.5.1001.5415
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Dengue Fever

Keywords

Resomelagon; Resolution of inflammation; Melanocortin; Dengue; RESOVIR-2

Outcome Measures

Primary Outcomes (2)

• Evaluate safety of Resomelagon in Dengue patients

  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 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 Outcomes (3)

• Efficacy of Resomelagon in reducing illness Severity

  10 days

• Efficacy of Resomelagon in reducing plasma leakage

  10 days

• Efficacy of Resomelagon in reducing dengue hospitalization or prolonged observation in the Emergency department

  10 days

Other Outcomes (3)

• Evaluation of proinflammatory cytokines.

  28 days

• Evaluation of proinflammatory chemokines.

  28 days

• Evaluation of cytokine production by mononuclear cells.

  28 days

Study Arms (2)

Resomelagon

EXPERIMENTAL

Resomelagon, 100mg, orally, once daily plus standard treatment

Drug: Resomelagon; Other: Standard Treatment

Placebo

PLACEBO COMPARATOR

Placebo plus standard treatment

Drug: Placebo; Other: Standard Treatment

Interventions

Resomelagon DRUG

Resomelagon 100mg, orally, once daily.

Resomelagon

Placebo DRUG

Placebo

Placebo

Standard Treatment OTHER

Hydration and symptomatic therapy as indicated for Dengue fever.

Placebo; Resomelagon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Instituto Nacional de Ciência e Tecnologia em Dengue (INCT em Dengue): collaborator

Study Sites (2)

Clinical Research Unit

Belo Horizonte, Minas Gerais, 30750140, Brazil

Location

Centro Integrado de Pesquisa

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

Related Publications (16)

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• Schilling WHK, Jittamala P, Watson JA, Boyd S, Luvira V, Siripoon T, Ngamprasertchai T, Batty EM, Cruz C, Callery JJ, Singh S, Saroj M, Kruabkontho V, Ngernseng T, Tanglakmankhong N, Tubprasert J, Abdad MY, Madmanee W, Kouhathong J, Suwannasin K, Pagornrat W, Piaraksa N, Hanboonkunupakarn P, Hanboonkunupakarn B, Poovorawan K, Potaporn M, Srisubat A, Loharjun B, Taylor WRJ, Chotivanich V, Chotivanich K, Imwong M, Pukrittayakamee S, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Antiviral efficacy of molnupiravir versus ritonavir-boosted nirmatrelvir in patients with early symptomatic COVID-19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial. Lancet Infect Dis. 2024 Jan;24(1):36-45. doi: 10.1016/S1473-3099(23)00493-0. Epub 2023 Sep 28.

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MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

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

Study Officials

• Mauro M Teixeira, MD PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro RJ Almeida, MD MSc

CONTACT

+5531995166160; pedrojesus@ufmg.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 8, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)