A Phase 2 interventional study of Resomelagon and Placebo in Dengue Fever, sponsored by Federal University of Minas Gerais. Recruiting at 2 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Federal University of Minas Gerais · Phase 2, Interventional, and Treatment
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.
Complications of dengue infection follows the peak of viremia and are associated with increased activation of the immune response. Proof-of-concept studies in animal models of dengue infection have shown that blocking certain aspects of the inflammatory response or the administration of pro-resolving molecules is beneficial in experimental dengue. In these experiments, the administration of certain anti-inflammatory or pro-resolution molecules decreases disease severity and aspects of the inflammatory response, including changes in vascular permeability. We have previously shown that treatment with RESOMELAGON decreased lung inflammation and outcome in animal models of beta coronavirus infection (including by SARS-CoV-2) and decreased disease severity in COVID-19 patients, even in the presence of glucocorticoid therapy. Preclinical experiments also showed that RESOMELAGON decreased disease severity in an animal model of dengue infection and decreased cytokine release by human PBMC infected with dengue virus. RESOMELAGON is safe in healthy individuals, those with rheumatoid arthritis, and patients with COVID-19. This is a placebo controlled, randomized, double-blinded clinical trial evaluating the safety and efficacy of Resomelagon in patients with acute dengue infection.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 120 is close to the median of 132 across 197 interventional studies indexed under Dengue.
Browse Dengue studies →Federal University of Minas Gerais is the lead sponsor of 152 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Resomelagon, 100mg, orally, once daily plus standard treatment
Drug: Resomelagon · Other: Standard Treatment
Placebo plus standard treatment
Drug: Placebo · Other: Standard Treatment
Resomelagon 100mg, orally, once daily.
Placebo
Hydration 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.
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
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
Evaluation of proinflammatory cytokines.
Measurement of proinflammatory cytokines using Meso Scale Discovery (MSD) platform with V-Plex proinflammatory panel 1 (Human).
Time frame: 28 days
Evaluation of proinflammatory chemokines.
Measurement of proinflammatory chemokines using Meso Scale Discovery (MSD) platform with V-Plex Chemokine Panel 1 (Human).
Time frame: 28 days
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.
Time frame: 28 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2026 (actual). Primary completion is estimated for Jun 2027, 15 months after the start.
Of 31 phase 2 interventional studies under Dengue, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 38. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Resomelagon
Federal University of Minas Gerais →