A Phase 3 interventional study of Placebo and Dexamethasone in Dengue, Severe Dengue and Mosquito-Borne Diseases, sponsored by Oxford University Clinical Research Unit, Vietnam. Not yet recruiting at 18 sites in 10 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Oxford University Clinical Research Unit, Vietnam · Phase 3, Interventional, and Treatment
The purpose of this multi-site, factorial randomised, platform trial is to evaluate host-directed therapeutic agents in patients hospitalised with moderate and severe dengue virus infection. Our primary aim is to find safe and affordable therapeutics which prevent disease progression among those at high risk for severe dengue, and improve outcomes for those with established severe disease, thereby also reducing the substantial burden placed on health systems in dengue endemic regions.
This multi-site, factorial randomised, platform clinical trial will evaluate host-directed therapeutic agents in patients hospitalised with moderate and severe dengue virus infection. The primary aim is to find safe and affordable therapeutics which prevent disease progression among those at high risk for severe dengue, and improve outcomes for those with established severe disease, thereby also reducing the substantial burden placed on health systems in dengue endemic regions.
The trial will employ partial factorial randomization. Participants who provide informed consent will be entered into one or more randomisations, depending on eligibility for each intervention, clinician discretion, and availability of the treatment at the study site. For each intervention, eligible participants will be randomised in a 1:1 ratio to receive either the active intervention or the corresponding control (either matched placebo or usual care, depending on the intervention). Participants who are ineligible for a specific treatment comparison may still enter other treatment comparisons within the trial.
Outcomes are described in more detail in the outcome section below. Participants will be followed up until death/day 30 after randomisation (whichever is sooner) to monitor for primary, secondary and safety outcomes. Participants who have been discharged from hospital alive before day 30 will have a final assessment conducted by telephone at least 30 days after randomisation.
Patients will be additionally consented for collection of a blood sample, taken and stored as a dried blood spot, for analyses in genetic studies and other research.
65 studies on the registry are indexed under Severe Dengue; 5 are open to participants now.
This study's planned enrollment of 8,800 is above the median of 170 across 52 interventional studies indexed under Severe Dengue.
Browse Severe Dengue studies →Oxford University Clinical Research Unit, Vietnam is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Compared within Severe Dengue, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dengue. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Participants must also have at least one 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.
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.
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.
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.
Participants eligible for baricitinib may be randomized to baricitinib or matched placebo.
Drug: Placebo · Drug: Baricitinib
Participants eligible for dexamethasone may be randomized to dexamethasone or matched placebo.
Drug: Placebo · Drug: Dexamethasone
Patients with liver involvement (ALT or AST \>400 IU/L) during hospital admission may be randomised to N-acetylcysteine or standard of care.
Drug: N-Acetylcysteine · Other: Standard of care
Placebo matched to baricitinib/dexamethasone in form, dose, frequency and duration.
Dexamethasone is a corticosteroid. Form: tablet or intravenous preparation. Dose: Aged ≥ 12 years: 6mg once daily. Aged 5 - 11 years by weight: * 10kg to \<20 kg: 2mg once daily, * 20kg to \<30 kg: 4mg once daily, * 30kg: 6mg once daily. Duration: 4 days, or until discharge if this happens before.
N-acetylcysteine acts to protect the liver. It functions as a glutathione precursor and antioxidant. Dose: 100mg/kg/day, by continuous infusion over 24 hours in glucose 5% (preferred) or sodium chloride 0.9%. Duration: 4 days, or until hospital discharge if sooner.
Standard of care as per local site guidelines
Baricitinib is an inhibitor of Janus Kinase (JAK) 1 \& 2, and Numb associated kinase (NAK). Form: tablet. Dose: Aged ≥ 12 years: 4mg once daily, Aged 5 - 11 years: 2mg once daily. - Renal adjustment of dose: Adults: eGFR ≥30 and \<60 mL/min/1.73m2: 2mg once daily, eGFR ≥15 and \<30 mL/min/1.73m2: 2mg on alternate days. Children: eGFR ≥30 and \<60mL/min/1.73m2: 2mg on alternate days \- Dose should be halved in patients also taking probenecid Duration: 4 days, or less if the patient is discharged before this time.
Progression to severe dengue/critical dengue
In the trial, baseline severity of dengue will be assessed at the start of study participation. Participants will be defined in accordance with our case definitions as having moderate, severe or critical dengue, based on clinical signs and symptoms, laboratory parameters, and if they have evidence of organ failure with or without need for organ support. At hospital discharge or following death, we will capture if the participant had evidence of at least one of: * Progression to Severe dengue, in a participant with moderate dengue at enrolment, * Progression to Critical dengue, in a participant with moderate or severe dengue at enrolment.
Time frame: between randomization to hospital discharge (average of 5 days)
All-cause mortality within 30 days
All-cause mortality in any participant. Assessed as dead or alive
Time frame: Day 30
Length of hospital stay
Number of days from hospital admission to discharge
Time frame: At hospital discharge (average of 5 days)
Lowest recorded platelet count
Lowest recorded platelet count between randomisation and hospital discharge
Time frame: Between randomisation and hospital discharge (average of 5 days)
Acute kidney injury
Serum creatinine \> 3.5 mg/dL or more than double baseline
Time frame: Between randomisation and hospital discharge (average of 5 days)
Liver involvement
Highest recorded ALT or AST
Time frame: Between randomisation and hospital discharge (average of 5 days)
Change in ALT/AST
N-acetylcysteine treatment comparison only. Fold change in ALT or AST
Time frame: at randomisation, day 2 (if feasible) and day 4 or hospital discharge (average on day 5) if sooner
Highest bilirubin
N-acetylcysteine treatment comparison only. Highest recorded bilirubin
Time frame: Between randomisation and hospital discharge (average of 5 days)
Highest INR
N-acetylcysteine treatment comparison only. Highest recorded INR
Time frame: Between randomisation and hospital discharge (average of 5 days)
Safety reporting: Suspected Severe Adverse Reactions
Suspected serious adverse reactions (SSARs) excluding primary outcomes
Time frame: During hospital stay (average of 5 days) and at day 30 follow up
Quality of live assessment using EQ-5D-5L value index
The EQ-5D-5L (EuroQoL \[European Quality of Life\] 5-Dimension 5-Level) is a standardized measure of health-related quality of life assessing five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is self-reported by the respondent and rated on five levels of severity, ranging from "no problems" (level 1) to "extreme problems/unable" (level 5). Responses across the five domains define a health state, which is converted into a single index (utility) score using population-based value sets. This index score typically ranges from values below 0 (health states considered worse than death) to 1 (perfect health).
Time frame: at day 30 follow up
Quality of live assessment using EQ-Visual Analogue Scale (VAS)
This is a self-rated measure of overall health. Respondent indicate their current health status on a vertical scale from 0 to 100. A score of 0 represents "the worst health you can imagine" and 100 represents "the best health you can imagine". This measure captures the respondent's subjective assessment of their overall health on the day of evaluation. When this assessment done remotely by telephone, the rating is approximated verbally by the respondent using the 0 to 100 numeric scale.
Time frame: at day 30 follow up
Plan to share: Yes — With ethical approval and patient consent, the database may be shared with researchers not directly involved in this study but only after the main paper has been published and in accordance with local and national policies. The database will only be shared if future publications are not compromised. No identifiable information will be shared with any other person/organisation than that authorised in the protocol.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2030, 45 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexamethasone · Acetylcysteine · Baricitinib
Oxford University Clinical Research Unit, Vietnam