Adaptive Dengue Antiviral Platform Trial
NCT Number: NCT06551844
Acronym: ADAPT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Dengue|Antiviral Drugs
Interventions: DRUG: Molnupiravir 400 mg|DRUG: VIS513 (a monoclonal antibody)
Sponsor: Oxford University Clinical Research Unit, Vietnam
Collaborators: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-09-01
Completion Date: 2030-12-31
Locations: Hospital for Tropical Diseases at Ho Chi Minh city, Ho Chi Minh City, 700000, Vietnam

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

Primary Outcome Measures: 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 Outcome Measures: Area under the viremia curve, Area under the curve (AUC) of the serial viremia measurements during the first 5 days of study, From randomisation until day 5 of study|Viral log reduction, Reduction of viremia at the 24 and 48 hours compared to baseline, up to 48 hours of study|NS1 clearance time, Time to NS1 clearance as estimated under a non-linear model, 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, 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, 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), From enrolment until discharge, assessed up to 30 days|Platelet nadir, The lowest platelet count recorded during admission, Until day 30 post-enrolment|Maximum AST/ALT, The highest values of AST/ALT measured, Until day 30 post-enrolment|Change in haematocrit, Change in haematocrit during the hospitalisation, Until day 30 post-enrolment