Phase 2 Adaptive Trial to Test Antiviral Drugs for Early Dengue Infection Evaluating Molnupiravir, Remdesivir, and Monoclonal Antibody Treatments

What this Trial Is About

Researchers are evaluating the antiviral effects of several experimental drugs in patients with early dengue infection, defined as those with confirmed dengue and less than 48 hours of fever. This adaptive platform trial aims to determine how well these drugs work against the dengue virus and assess their safety and tolerability. The study also explores how these drugs affect various physiological and clinical markers in dengue patients. Participants are randomly assigned to one of four groups standard care with no study drug, molnupiravir taken orally twice daily for five days, a single intravenous dose of a dengue monoclonal antibody called VIS513, or remdesivir dosed according to weight over five days. The trial is open-label and adaptive, allowing for the addition of new treatments or removal of less effective ones based on ongoing results. During the trial, participants will be monitored from randomization through day 5 for viral clearance and safety, with further follow-up visits at 30 and 60 days after enrollment. Researchers will assess virus levels, fever duration, clinical progression, and laboratory measures such as platelet count and liver enzymes. Safety events and adverse effects are also tracked up to 30 days post-enrollment to ensure participant well-being throughout the study.

Adaptive Dengue Antiviral Platform Trial