Adaptive Dengue Antiviral Platform Trial
ADAPT
1 other identifier
interventional
500
2 countries
2
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
August 13, 2024
CompletedStudy Start
First participant enrolled
April 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 30, 2026
April 1, 2026
3.7 years
August 6, 2024
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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.
Until day 30 post-enrolment
Secondary Outcomes (9)
Area under the viremia curve
From randomisation until day 5 of study
Viral log reduction
up to 48 hours of study
NS1 clearance time
up to day 5
Number of patients progress to severe dengue (WHO 2009 criteria)
From enrolment until discharge, assessed up to 30 days
Number of patients requiring for ICU admission
From enrolment until discharge, assessed up to 30 days
- +4 more secondary outcomes
Study Arms (4)
Standard of care (arm A)
NO INTERVENTIONPatients, who are randomly allocated into arm A will receive the standard of care (no study drug)
Molnupiravir (arm B)
EXPERIMENTALPatients, who are randomly allocated into arm B, will receive 800mg po bid of Molnupiravir for 5 days
Monoclonal antibody (arm C)
EXPERIMENTALPatients, 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)
EXPERIMENTALPatients, 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.
Interventions
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 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 (GS-443902) is a nucleoside analogue - RNA dependent RNA polymerase inhibitor. In a meta-analysis of 10 RCTs and 32 observational studies reporting on the use of Remdesivir in COVID-19, remdesivir reduced mortality from severe disease and shortened time to clinical improvement. In this trial, its antiviral effectiveness on the early phase of dengue virus infection will be assessed
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Universiti Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital for Tropical Diseases, Ho Chi Minh city
Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie Yacoub, MD., PhD.
University of Oxford, UK
Central Study Contacts
Clinical Trials Unit Oxford University Clinical Research Unit
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2024
First Posted
August 13, 2024
Study Start
April 20, 2026
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2030
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- starting 6 months after publications of study findings
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.