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Adaptive Dengue Antiviral Platform Trial
Sponsor: Oxford University Clinical Research Unit, 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
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
Key Details
Gender
All
Age Range
10 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-09-01
Completion Date
2030-12-31
Last Updated
2024-08-13
Healthy Volunteers
No
Conditions
Interventions
Molnupiravir 400 mg
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)
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.
Locations (1)
Hospital for Tropical Diseases at Ho Chi Minh city
Ho Chi Minh City, Vietnam