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.
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.
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;
Parallel
Resomelagon
DrugResomelagon 100mg, orally, once daily.
Placebo
DrugPlacebo
Standard Treatment
Other interventionHydration and symptomatic therapy as indicated for Dengue fever.
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.
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.
Efficacy of Resomelagon in reducing illness Severity
Incidence of dengue with warning signs or severe dengue in the study patients
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
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
Evaluation of proinflammatory cytokines.
Measurement of proinflammatory cytokines using Meso Scale Discovery (MSD) platform with V-Plex proinflammatory panel 1 (Human).
Evaluation of proinflammatory chemokines.
Measurement of proinflammatory chemokines using Meso Scale Discovery (MSD) platform with V-Plex Chemokine Panel 1 (Human).
Evaluation of cytokine production by mononuclear cells.
Mononuclear cells from peripheral blood will be evaluated by flow cytometry for assessment of their surface inflammatory biomarkers.
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Federal University of Minas Gerais
Lead sponsor
Instituto Nacional de Ciência e Tecnologia em Dengue (INCT em Dengue)
Collaborator
