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NOT YET RECRUITING
NCT06551844
PHASE2

Adaptive Dengue Antiviral Platform Trial

Sponsor: Oxford University Clinical Research Unit, Vietnam

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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