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

Phase 2Not Yet RecruitingNCT06917001

Federal University of Minas Gerais120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Dengue Fever

Interventions

ResomelagonDRUG

Resomelagon 100mg, orally, once daily.

PlaceboDRUG

Placebo

Standard TreatmentOTHER

Hydration and symptomatic therapy as indicated for Dengue fever.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

Clinical Research Unit

Belo Horizonte, Minas Gerais, Brazil

Centro Integrado de Pesquisa

São José do Rio Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 10 days

Secondary Outcomes

Efficacy of Resomelagon in reducing illness Severity

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

Time frame: 10 days

Efficacy of Resomelagon in reducing plasma leakage

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

Time frame: 10 days

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

Incidence of a stay of more than 12h in the emergency department or hospital admission

Time frame: 10 days

Central Contacts

Pedro RJ Almeida, MD MSc

CONTACT

+5531995166160 pedrojesus@ufmg.br

Data from ClinicalTrials.gov

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