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DenguePhase 3DEN-HOSTNCT07543458

Therapeutics for Moderate and Severe Dengue

A Phase 3 study testing Dexamethasone, N-Acetylcysteine and Baricitinib in people with Dengue and Severe Dengue, run by Oxford University Clinical Research Unit, Vietnam at 18 sites in 10 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 5 years and older
Conditions the study is for
Dengue, Severe Dengue, Mosquito-Borne Diseases
What is being tested?
Dexamethasone, N-Acetylcysteine and Baricitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,800 participants
Where
18 sitesin 10 countries
Study dates
1 Oct 2026to 31 Jul 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥5 years
  • Decision to hospitalise
  • Clinical diagnosis of dengue
  • Participants must also have at least one of the following:
  • Severe abdominal pain or tenderness
  • Vomiting more than 3 times in the past 24 hours
Show all 16Show fewer
  • Pleural effusion or ascites on clinical or radiological examination
  • Absolute haematocrit >50%
  • 15% increase in haematocrit compared with a baseline sample (defined as the first sample taken during the current illness)
  • Absolute platelet count <50 × 10⁹/L
  • Absolute platelet count <100 × 10⁹/L AND a drop >50 × 10⁹/L in the past 32 hours
  • ALT or AST >400 IU/L
  • Pulse pressure <20mmHg or hypotension for age AND at least one of: peripheral capillary refill time >2 seconds; urine output 0.5ml/kg/hr; cold/clammy peripheries; agitation or altered mental state
  • Bleeding leading to hypotension for age or requiring blood transfusion or medical intervention (e.g. surgery, endoscopy, or vasoactive drugs)
  • Symptomatic bleeding into a critical site (intracranial, intraspinal, intraocular with visual impairment, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome)
  • Requirement for organ support, including vasopressors or inotropes, assisted ventilation, dialysis or haemofiltration, or coma (unresponsive to pain without sedation) or requirement for intravenous antiseizure medications

Who cannot join

  • Patients on ≥ day 10 of illness or who are clinically improving in the opinion of the managing doctor (the 'recovery phase') will be excluded from recruitment. Other exclusion criteria are specific to individual treatment comparisons, and do not preclude randomisation to other arms of the study.
  • A participant may not enter a specific treatment comparison if that treatment is considered to be indicated or contraindicated by the responsible clinician.

Trial locations and contacts

18 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Mr. Samuel Paul contact

den-host@ndm.ox.ac.uk

OUCRU-CTU contact

+84283924193

CTU-Wthics@oucru.org

18 sites in 10 countries

Bangladesh3 sites

  • Chittagong Medical College Hospital

    Chittagong

    Aniruddha Ghose, Prof, anrdghs@yahoo.com

  • Dhaka Medical College & Hospital

    Dhaka

    Md. Jobayer Chisti, MD, chisti@icddrb.org,

    Lubaba Shahrin, MD, lubabashahrin@icddrb.org

  • Dhaka North City Corporation Hospital

    Dhaka

    Lubaba Shahrin, MD, lubabashahrin@icddrb.org

Other trials in Bangladesh

Colombia3 sites

  • Centro de Atención y Diagnóstico de Enfermedades Infecciosas

    Bucaramanga

    Luis A Villar, MD, direccioninvestigacion@cdi.net.co

  • Fundación Valle del Lili

    Cali

    Carlos Cotes, MD, centrodeinvestigaciones@fvl.org.co

  • Hospital Universitario Erasmo Meoz

    Cúcuta

Other trials in Colombia

Malaysia2 sites

  • Hospital Queen Elizabeth II, Sabah

    Kota Kinabalu

    Giri Rajaharam, MD, gsrajahram@gmail.com

  • University Malaya Medical Centre

    Kuala Lumpur

    Mohad Shahnaz Hasan, MD

    Ong Hang-Cheng, MD, ong.hc@ummc.edu.my

Other trials in Malaysia

Nepal2 sites

  • National Academy of Medical Sciences/Bir Hospital

    Kathmandu

    Sudeep Adhikari, MD, sadhikari@oucru.org

  • Sukraraj Tropical and Infectious Disease Hospital

    Kathmandu

    Sudeep Adhikari, MD, sadhikari@oucru.org

Other trials in Nepal

Thailand2 sites

  • Siriraj Hospital, Mahidol University

    Bangkok

    Nasikarn Angkasekwinai, MD, nasikarn@gmail.com

    Panisadee Avirutnan, MD

  • Prince of Songkla University in Southern Thailand

    Songkhla

    Nasikarn Angkasekwinai, MD, nasikarn@gmail.com

Other trials in Thailand

Vietnam2 sites

  • Hospital for Tropical Diseases

    Ho Chi Minh City

    Dung Thanh Nguyen, MD

    Trung Ngoc Truong, MD, drngoctrung2984@gmail.com

  • Number 2 Children's Hospital

    Ho Chi Minh City

    Tung Huu Trinh, MD

    Qui Dinh Nguyen, MD

Other trials in Vietnam

Brazil1 site

  • Instituto de Infectologia Emílio Ribas

    São Paulo

    Claudia Figueiredo Mello, MD, claudia.mello@emilioribas.sp.gov.br

Other trials in Brazil

Indonesia1 site

  • Universitas Sumatera Utara

    Medan

    Inke Nadia Diniyanti Lubis, MD, inke.nadia@usu.ac.id

Other trials in Indonesia

Peru1 site

  • Hospital Regional de Loreto

    Iquitos

    Juan Carlos Celis Salinas, MD, gipeit@gmail.com

Other trials in Peru

Philippines1 site

  • San Lazaro Hospital

    Manila

    Ana Ria Sayo, MD, sayoanaria@gmail.com

Other trials in Philippines

About this study

Official title: A Randomised Platform Trial to Evaluate Therapeutics in Patients With Moderate or Severe Dengue (DEN-HOST)

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.

Read the detailed description

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.

Being tested
Placebo, Dexamethasone, N-Acetylcysteine, Standard of care, Baricitinib
Keywords
dengue treatment, host-directed therapy, host-targeted therapeutics
Medical subject headings
Dengue, Severe Dengue, Mosquito-Borne Diseases, Vector Borne Diseases, Arbovirus Infections, Flavivirus Infections, RNA Virus Infections, Hemorrhagic Fevers, Viral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo matched to baricitinib/dexamethasone in form, dose, frequency and duration.

  • DexamethasoneDrug

    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-AcetylcysteineDrug

    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 careOther

    Standard of care as per local site guidelines

  • BaricitinibDrug

    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.
Study groups in NCT07543458
Study groupRoleWhat they receive
Comparison A: Baricitinib versus placeboExperimentalParticipants eligible for baricitinib may be randomized to baricitinib or matched placebo.
Receives: Drug: Placebo; Drug: Baricitinib
Comparison B: Dexamethasone versus PlaceboExperimentalParticipants eligible for dexamethasone may be randomized to dexamethasone or matched placebo.
Receives: Drug: Placebo; Drug: Dexamethasone
Comparison C: N-acetylcysteine versus standard of careExperimentalPatients with liver involvement (ALT or AST >400 IU/L) during hospital admission may be randomised to N-acetylcysteine or standard of care.
Receives: Drug: N-Acetylcysteine; Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: between randomization to hospital discharge (average of 5 days)

  2. All-cause mortality within 30 days

    All-cause mortality in any participant. Assessed as dead or alive

    Measured: Day 30

Secondary outcomes (10)

  1. Length of hospital stay

    Number of days from hospital admission to discharge

    Measured: At hospital discharge (average of 5 days)

  2. Lowest recorded platelet count

    Lowest recorded platelet count between randomisation and hospital discharge

    Measured: Between randomisation and hospital discharge (average of 5 days)

  3. Acute kidney injury

    Serum creatinine > 3.5 mg/dL or more than double baseline

    Measured: Between randomisation and hospital discharge (average of 5 days)

  4. Liver involvement

    Highest recorded ALT or AST

    Measured: Between randomisation and hospital discharge (average of 5 days)

  5. Change in ALT/AST

    N-acetylcysteine treatment comparison only. Fold change in ALT or AST

    Measured: at randomisation, day 2 (if feasible) and day 4 or hospital discharge (average on day 5) if sooner

  6. Highest bilirubin

    N-acetylcysteine treatment comparison only. Highest recorded bilirubin

    Measured: Between randomisation and hospital discharge (average of 5 days)

  7. Highest INR

    N-acetylcysteine treatment comparison only. Highest recorded INR

    Measured: Between randomisation and hospital discharge (average of 5 days)

  8. Safety reporting: Suspected Severe Adverse Reactions

    Suspected serious adverse reactions (SSARs) excluding primary outcomes

    Measured: During hospital stay (average of 5 days) and at day 30 follow up

  9. 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).

    Measured: at day 30 follow up

  10. 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.

    Measured: at day 30 follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Jul 2030 (estimated)
  4. Study completion31 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
This multi-site, phase 3, randomised, clinical trial will evaluate therapeutic agents in patients hospitalised with moderate or severe dengue virus infection. The trial will employ partial factorial randomisation. 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. Patients are randomised to Baricitinib versus placebo (Comparison A) and/or Dexamethasone versus placebo (Comparison B) depending on eligibility. Participants who are ineligible for one intervention are randomized only to the other intervention. In addition, participants with evidence of liver involvement undergo a second, independent randomisation to receive N-acetylcysteine or standard of care (Comparison C). This second randomisation may occur at any time during admission, when the patient is first noted to fulfil the eligibility criteria during the main trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07543458
Sponsor's protocol ID
OxTREC 3271082
Other IDs
323061/Z/24/Z
Acronym
DEN-HOST
Status last verified
Apr 2026
First submitted
8 Apr 2026
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone, N-Acetylcysteine and Baricitinib in people with Dengue and Severe Dengue, run by Oxford University Clinical Research Unit, Vietnam at 18 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Bangladesh, Colombia, Malaysia, Nepal, Thailand and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mr. Samuel Paul (den-host@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression to severe dengue/critical dengue (time frame: between randomization to hospital discharge (average of 5 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07543458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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