An observational study in DENV Without Warning Signs, DENV with Warning Signs and Severe Dengue, sponsored by Karolinska Institutet. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Karolinska Institutet · Observational
The goal of this observational study is to identify biomarkers and host factors associated with dengue severity in patients from dengue-endemic regions. The main question it aims to answer is:
Can multi-omics approaches predict disease severity and identify key factors contributing to severe dengue infections?
Participants will include individuals with dengue infection, and the study will analyze their blood samples using multi-omics techniques to uncover host immune responses, disease pathogenesis, and cellular pathway interactions. The study will also assess the role of primary and secondary infections, virus serotypes, and immunological factors in disease progression. Findings aim to support disease management, improve severity prediction, and identify potential therapeutic targets to prevent severe outcomes.
Background: Many ongoing dengue clinical trials aim to evaluate both therapeutic compounds and potential vaccine candidates. The therapeutic compounds aim to target various stages of dengue virus replication, such as viral entry, by inhibiting virus fusion, NS5 polymerase inhibitor, and NS1 antigenemia reduction, to mention a few. However, an omics-based approach to identifying the metabolic pathways that dengue utilizes to subvert the host system to derive energy from and subsequently deploy viral immune evasion strategies has yet to be established. This study will focus on exploring and understanding the pathways that the dengue virus exploits and investigate if blocking the identified pathway can cause the virus to 'starve.'
The primary objectives of the proposed study are:
Study Cohorts:
Clinical material from two endemic regions, one from Central America (Guatemala) and Southeast Asia (India) will be used. Guatemala is an exemplary location for studying the DENV infection, owing to its distinctive combination of climatic diversity and endemic and dengue presence. Two blood samples (on the day of hospitalization and the day of discharge) from the patients will be collected as per the WHO revised 2009 case classification: 1) dengue without warning signs (DwoWS, n=200), 2) dengue with warning signs (DWS, n=200), 3) severe dengue (SD, n=200). Additionally, non-dengue samples will be collected from healthy controls (n=200). This cohort will act as the DISCOVERY cohort. We will collect whole blood in a TempusTM tube (for RNA sequencing) and serum (for proteomics and metabolomics).
Under the India-EU cooperation on research \& innovation (R\&I) and co-funding partnership under the EU framework program on R\&I 'Horizon Europe, samples will be collected from India, from Artemis Hospital, New Delhi, Max Health Care, New Delhi (a unit of Devki Devi Foundation) and Kasturba Medical College Hospital, Mangalore. Those are the two epicentres of the dengue endemic in India. 50 samples from each dengue severity classification (total samples 150 in each category) and DENV-negative healthy control (total 150: 50 in each site) will be collected. The Indian cohorts will act as the VALIDATION cohorts.
Recruitment of controls Healthy participants who have tested negative for dengue infection in the past three months will not be recruited to the study, which will be further age-and gender-matched with the cases. These samples will be tested for anti-dengue IgM and NS1 ELISA to rule out ongoing asymptomatic infection. They will also be subjected to anti-dengue IgG ELISA to check for past dengue infection. Each of the control participants will also be asked to provide a detailed medical history
65 studies on the registry are indexed under Severe Dengue; 5 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 667 across 13 observational studies indexed under Severe Dengue.
Browse Severe Dengue studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Group 1: Dengue without warning signs Patients presenting with the following symptoms confirmed positive for dengue infection by lab diagnosis by anti-dengue IgM or NS1 ELISA will be recruited for the study under this cohort.
Symptoms will be fever along with at least two of the following -
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.
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.
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.
Laboratory confirmed Dengue without plasma leakage
Other: Infection and no infection
Laboratory confirmed Dengue without plasma leakage plus abdominal pain, persistent vomiting, fluid accumulation, mucosal bleeding, lethargy, liver enlargement, increasing haematocrit with decreasing platelets
Other: Infection and no infection
Dengue with severe plasma leakage, severe bleeding, or organ failure
Other: Infection and no infection
Healthy participants who have tested negative for dengue infection
No intervention apart from the dengue infection
DISCOVER predictive biomarkers and AI tool for Dengue Severity
This project aims to identify prognostic plasma protein biomarkers for disease severity in dengue virus (DENV) using data from a clinical cohort in an endemic region experiencing a surge in DENV morbidity and mortality. It involves developing a novel consensus association-based gene/protein cooperation network to uncover key host factors driving severe disease. Additionally, the project seeks to create AI-driven prognostic tools for predicting DENV severity by integrating patient demographic and clinical data with gene and protein biomarkers, DENV serotyping, and climate information.
Time frame: From enrollment to the end of hospitalisation at 2 weeks
Plan to share: Undecided — Annonymised and delinked IPD can be shared after the completion of the study after getting approval from the steering board and obtaining the ethical clearance of the requesting party.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
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