DenguePhase 2ADAPTNCT06551844
Adaptive Dengue Antiviral Platform Trial
A Phase 2 study testing Molnupiravir 400 mg, VIS513 (a monoclonal antibody) and Remdesivir 100mg in people with Dengue and Antiviral Drugs, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in 2 countries.
Trial summary
This is a randomized, open-label adaptive platform trial aiming to screen the antiviral effectiveness of the experimental drug(s) in early dengue infection Primary objectives: To determine the antiviral effectiveness of the experimental drug(s) in early dengue infection To assess the safety and tolerability of the… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Dengue, Antiviral Drugs
- What is being tested?
- Molnupiravir 400 mg, VIS513 (a monoclonal antibody) and Remdesivir 100mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Apr 2026to 31 Dec 2030
- Phase
- Phase 2
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female or male patients with a clinical diagnosis of dengue virus infection and less than 48 hours of fever
- Positive NS1 rapid diagnostic test
- >= 10 years or ≥ 18 years of age (depending on license of therapeutic being evaluated)
- Patient is able to give written informed consent or assent for full participation in the study.
- Agreement to stay in hospital for duration of the intervention (most will be 5 days) and follow-up visits at day 30 and 60 post enrolment.
Who cannot join
- Meets criteria for severe dengue at baseline (severe plasma leakage leading to dengue shock syndrome, fluid accumulation with respiratory distress, severe bleeding, severe organ involvement - AST/ALT>1000 U/L, impaired consciousness, multiple organ dysfunction)
- Pregnancy (either clinically confirmed or by urine dipstick for human chorionic gonadotrophin hormone)
- Breastfeeding women
- Localising features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis
- Renal failure (baseline eGFR < 30ml/min)
- History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders
Show all 9Show fewer
- History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed)
- Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant
- Participation or planned participation in a study involving the administration of an investigational compound within the past one month.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Clinical Trials Unit Oxford University Clinical Research Unit contact
2 sites in 2 countries
Malaysia1 site, 1 recruiting
- Not yet recruiting
Universiti Malaya Medical Centre
Kuala Lumpur, 59100
Hang Cheng Ong, Doctor
Vietnam1 site, 1 recruiting
- Recruiting
Hospital for Tropical Diseases, Ho Chi Minh city
Ho Chi Minh City, 700000
Lan TH Nguyen, Doctor
Lan TH Nguyen, Doctor
About this study
Official title: Adaptive Dengue Antiviral Platform Trial (ADAPT): a Phase 2 Randomized, Adaptive, Open Label Trial for Antiviral Screening in Patients With Early Symptomatic Dengue
This is a randomized, open-label adaptive platform trial aiming to screen the antiviral effectiveness of the experimental drug(s) in early dengue infection
- Primary objectives:
- To determine the antiviral effectiveness of the experimental drug(s) in early dengue infection
- To assess the safety and tolerability of the experimental drug(s) in dengue patients
- Secondary objective:
- To assess the effect of the experimental drug(s) in dengue patients on physiological, clinical and virological parameters
Read the detailed description
This is a randomized, open-label adaptive platform trial investigating the antiviral effectiveness of various intervention arms in patients with lab-confirmed dengue and less than 48 hours of fever. The antiviral candidates in this trial will include the repurposed antiviral drugs, novel small molecule drugs and dengue monoclonal antibody. Patients will be randomly allocated between available treatment arms and compared to standard of care ("no study drug": no placebos will be made for this trial).
The current sites include Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam and Universiti Malaya Medical Centre, Kuala Lumpur, Malaysia. Local ethical approvals have been released. Other sites and countries may be added in due course.
This is a continually running adaptive platform trial, which begins with initial candidate drugs (a total of 4 arms): molnupiravir, remdesivir and VIS513 (a dengue monoclonal antibody). New therapies may be added and poorly performing arms or interventions meeting pre-specific thresholds for in vivo antiviral efficacy will be removed.
The sample size is adaptive with multiple planned interim analyses. The number of patients recruited depends on the results. For each intervention studied the sample size will be adaptive and determined by pre-specified stopping rules for futility and efficacy. Patients are invited to participate in the trial if they present at the healthcare settings with early symptomatic dengue virus infection (less than 48 hours since the onset of fever and positive NS1 antigen test) and can be able to return for follow up visits at 30 and 60 days after randomization.
The randomization ratios will be uniform for all available and eligible arms (1:1:1...).
- Conditions
- Dengue, Antiviral Drugs
- Being tested
- Molnupiravir 400 mg, VIS513 (a monoclonal antibody), Remdesivir 100mg
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molnupiravir 400 mgDrug
Also called Molnupiravir STELLA 400mg
This is an antiviral drug (an RNA dependent RNA polymerase inhibitor, with broad spectrum antiviral activity) currently approved for use in treatment for COVID-19 patients.
In this trial, its antiviral effectiveness on the early phase of dengue virus infection will be assessed.
VIS513 (a monoclonal antibody)Drug
Also called Dengue monoclonal antibody (Dengue mAb/ Dv Mab)
VIS513 is an engineered humanised monoclonal antibody produced by recombinant DNA technology in a mammalian cell (i.e. Chinese hamster ovary) line. It was discovered in the USA by Visterra Inc and subsequently technology for manufacturing and further development was transferred to Serum Institute of India Pvt. Ltd., Pune, India. It has shown potent, specific neutralization of all four serotypes of DENV.
Remdesivir 100mgDrug
Also called VEKLURY™ for IV Infusion 100 mg
Remdesivir (GS-443902) is a nucleoside analogue - RNA dependent RNA polymerase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (arm A) | No intervention | Patients, who are randomly allocated into arm A will receive the standard of care (no study drug) |
| Molnupiravir (arm B) | Experimental | Patients, who are randomly allocated into arm B, will receive 800mg po bid of Molnupiravir for 5 days Receives: Drug: Molnupiravir 400 mg |
| Monoclonal antibody (arm C) | Experimental | Patients, who are randomly allocated into arm C, will receive a single dose of 6mg/Kg of the dengue monoclonal antibody via an intravenous line over 2 hours. Receives: Drug: VIS513 (a monoclonal antibody) |
| Remdesivir (arm D) | Experimental | Patients, who are randomly allocated into arm D, will receive:
* Adults or children ≥ 40Kg: 200mg loading dose on day 1, followed by 100mg once daily from day 2 to day 5.
* Children < 40Kg: 5mg/Kg loading dose on day 1, followed by 2.5mg/Kg once daily from day 2 to day 5. Receives: Drug: Remdesivir 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral clearance rate
Rate of viral clearance estimated under a hierarchical log-linear model fit to the serial viral load measurements over 5 days after enrolment. The viremia kinetics will be measured using the qRT-PCR assay, which will be performed on samples taken twice a day from day 1 to day 3 of study and then once a day on days 4 and 5 of study (total 9 samples per patient).
Measured: From randomization until day 5 of study
Number of AEs (grade 3, 4 and 5)
All patients will be followed up daily until discharge and then at around days 30 after randomization to collect information on clinical progress of dengue illness and any adverse events occurring during the study course. All AEs and SAEs will be recorded.
Measured: Until day 30 post-enrolment
Secondary outcomes (9)
Area under the viremia curve
Area under the curve (AUC) of the serial viremia measurements during the first 5 days of study
Measured: From randomisation until day 5 of study
Viral log reduction
Reduction of viremia at the 24 and 48 hours compared to baseline
Measured: up to 48 hours of study
NS1 clearance time
Time to NS1 clearance as estimated under a non-linear model
Measured: up to day 5
Number of patients progress to severe dengue (WHO 2009 criteria)
All patients will be followed up daily until discharge to collect information about the clinical progress of dengue
Measured: From enrolment until discharge, assessed up to 30 days
Number of patients requiring for ICU admission
All patients will be followed up daily until discharge to collect information about the clinical progress of dengue
Measured: From enrolment until discharge, assessed up to 30 days
Fever clearance time
Time elapsed from enrolment to the afebrile time-point (defined as body temperature <37.5 °C for at least 48 hours)
Measured: From enrolment until discharge, assessed up to 30 days
Platelet nadir
The lowest platelet count recorded during admission
Measured: Until day 30 post-enrolment
Maximum AST/ALT
The highest values of AST/ALT measured
Measured: Until day 30 post-enrolment
Change in haematocrit
Change in haematocrit during the hospitalisation
Measured: Until day 30 post-enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start20 Apr 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a phase 2 randomized, adaptive, open label trial for antiviral screening in patients with dengue presenting at the healthcare settings within 48 hours.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, University of Malaya
- Responsible party
- Sponsor
- Investigators
- Sophie Yacoub, MD., PhD., Principal investigator, University of Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551844
- Sponsor's protocol ID
- 71DX
- Acronym
- ADAPT
- Status last verified
- Apr 2026
- First submitted
- 6 Aug 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 OUCRU guidelines on data sharing. 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Dengue Antiviral Platform Trial (ADAPT): a Phase 2 Randomized, Adaptive, Open Label Trial for Antiviral Screening in Patients With Early Symptomatic Dengue
- ClinicalTrials.gov ID
- NCT06551844
- Acronym / sponsor ID
- ADAPT / 71DX
- Conditions
- Dengue, Antiviral Drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, University of Malaya
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label adaptive platform trial aiming to screen the antiviral effectiveness of the experimental drug(s) in early dengue infection
- Primary objectives:
- To determine the antiviral effectiveness of the experimental drug(s) in early dengue infection
- To assess the safety and tolerability of the experimental drug(s) in dengue patients
- Secondary objective:
- To assess the effect of the experimental drug(s) in dengue patients on physiological, clinical and virological parameters
Detailed description
This is a randomized, open-label adaptive platform trial investigating the antiviral effectiveness of various intervention arms in patients with lab-confirmed dengue and less than 48 hours of fever. The antiviral candidates in this trial will include the repurposed antiviral drugs, novel small molecule drugs and dengue monoclonal antibody. Patients will be randomly allocated between available treatment arms and compared to standard of care ("no study drug": no placebos will be made for this trial).
The current sites include Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam and Universiti Malaya Medical Centre, Kuala Lumpur, Malaysia. Local ethical approvals have been released. Other sites and countries may be added in due course.
This is a continually running adaptive platform trial, which begins with initial candidate drugs (a total of 4 arms): molnupiravir, remdesivir and VIS513 (a dengue monoclonal antibody). New therapies may be added and poorly performing arms or interventions meeting pre-specific thresholds for in vivo antiviral efficacy will be removed.
The sample size is adaptive with multiple planned interim analyses. The number of patients recruited depends on the results. For each intervention studied the sample size will be adaptive and determined by pre-specified stopping rules for futility and efficacy. Patients are invited to participate in the trial if they present at the healthcare settings with early symptomatic dengue virus infection (less than 48 hours since the onset of fever and positive NS1 antigen test) and can be able to return for follow up visits at 30 and 60 days after randomization.
The randomization ratios will be uniform for all available and eligible arms (1:1:1...).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a phase 2 randomized, adaptive, open label trial for antiviral screening in patients with dengue presenting at the healthcare settings within 48 hours.
| Arm | Type | Receives |
|---|---|---|
| Standard of care (arm A) | No intervention | –Patients, who are randomly allocated into arm A will receive the standard of care (no study drug) |
| Molnupiravir (arm B) | Experimental | Drug: Molnupiravir 400 mgPatients, who are randomly allocated into arm B, will receive 800mg po bid of Molnupiravir for 5 days |
| Monoclonal antibody (arm C) | Experimental | Drug: VIS513 (a monoclonal antibody)Patients, who are randomly allocated into arm C, will receive a single dose of 6mg/Kg of the dengue monoclonal antibody via an intravenous line over 2 hours. |
| Remdesivir (arm D) | Experimental | Drug: Remdesivir 100mgPatients, who are randomly allocated into arm D, will receive: * Adults or children ≥ 40Kg: 200mg loading dose on day 1, followed by 100mg once daily from day 2 to day 5. * Children < 40Kg: 5mg/Kg loading dose on day 1, followed by 2.5mg/Kg once daily from day 2 to day 5. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male patients with a clinical diagnosis of dengue virus infection and less than 48 hours of fever
- Positive NS1 rapid diagnostic test
- >= 10 years or ≥ 18 years of age (depending on license of therapeutic being evaluated)
- Patient is able to give written informed consent or assent for full participation in the study.
- Agreement to stay in hospital for duration of the intervention (most will be 5 days) and follow-up visits at day 30 and 60 post enrolment.
Key exclusion criteria (9 listed)
- Meets criteria for severe dengue at baseline (severe plasma leakage leading to dengue shock syndrome, fluid accumulation with respiratory distress, severe bleeding, severe organ involvement - AST/ALT>1000 U/L, impaired consciousness, multiple organ dysfunction)
- Pregnancy (either clinically confirmed or by urine dipstick for human chorionic gonadotrophin hormone)
- Breastfeeding women
- Localising features suggesting an alternative/additional diagnosis, e.g. pneumonia, sepsis
- Renal failure (baseline eGFR < 30ml/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molnupiravir 400 mgAlso: Molnupiravir STELLA 400mgThis is an antiviral drug (an RNA dependent RNA polymerase inhibitor, with broad spectrum antiviral activity) currently approved for use in treatment for COVID-19 patients. In this trial, its antiviral effectiveness on the early phase of dengue virus infection will be assessed. | Drug | Molnupiravir (arm B) |
| VIS513 (a monoclonal antibody)Also: Dengue monoclonal antibody (Dengue mAb/ Dv Mab)VIS513 is an engineered humanised monoclonal antibody produced by recombinant DNA technology in a mammalian cell (i.e. Chinese hamster ovary) line. It was discovered in the USA by Visterra Inc and subsequently technology for manufacturing and further development was transferred to Serum Institute of India Pvt. Ltd., Pune, India. It has shown potent, specific neutralization of all four serotypes of DENV. | Drug | Monoclonal antibody (arm C) |
| Remdesivir 100mgAlso: VEKLURY™ for IV Infusion 100 mgRemdesivir (GS-443902) is a nucleoside analogue - RNA dependent RNA polymerase inhibitor. | Drug | Remdesivir (arm D) |
Primary outcome
Viral clearance rate
Time frame: From randomization until day 5 of study
Rate of viral clearance estimated under a hierarchical log-linear model fit to the serial viral load measurements over 5 days after enrolment. The viremia kinetics will be measured using the qRT-PCR assay, which will be performed on samples taken twice a day from day 1 to day 3 of study and then once a day on days 4 and 5 of study (total 9 samples per patient).
Number of AEs (grade 3, 4 and 5)
Time frame: Until day 30 post-enrolment
All patients will be followed up daily until discharge and then at around days 30 after randomization to collect information on clinical progress of dengue illness and any adverse events occurring during the study course. All AEs and SAEs will be recorded.
9 secondary outcomes
Area under the viremia curve
Time frame: From randomisation until day 5 of study
Viral log reduction
Time frame: up to 48 hours of study
NS1 clearance time
Time frame: up to day 5
Number of patients progress to severe dengue (WHO 2009 criteria)
Time frame: From enrolment until discharge, assessed up to 30 days
Number of patients requiring for ICU admission
Time frame: From enrolment until discharge, assessed up to 30 days
Fever clearance time
Time frame: From enrolment until discharge, assessed up to 30 days
Platelet nadir
Time frame: Until day 30 post-enrolment
Maximum AST/ALT
Time frame: Until day 30 post-enrolment
Change in haematocrit
Time frame: Until day 30 post-enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. 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 OUCRU guidelines on data sharing. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trials Unit Oxford University Clinical Research Unit contact
Sophie Yacoub, MD., PhD. principal investigator
University of Oxford, UK
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Molnupiravir 400 mg, VIS513 (a monoclonal antibody) and Remdesivir 100mg in people with Dengue and Antiviral Drugs, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in 2 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia, Vietnam. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sophie Yacoub, MD., PhD. (+84 77728736, syacoub@oucru.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral clearance rate (time frame: From randomization until day 5 of study). 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?
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 28 Sep 2026.