Emetine for Viral Outbreaks: A Phase 2/3 Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Emetine for Dengue Fever (a.k.a. EVOLVE Antiviral Initiative)
Johns Hopkins University
Summary
The goal of this study is to evaluate the efficacy and safety of emetine administered orally for symptomatic patients aged 18-65 years infected with the dengue virus. The main questions it aims to answer are: 1. Does emetine reduce 28-day mortality or progression to severe dengue (severe plasma leakage, severe bleeding, or severe organ involvement)? 2. What are the safety outcomes of emetine, including serious adverse events and toxicities? Participants will be asked to: 1. Take either 6mg emetine, 12mg emetine, or a placebo pill for 7 consecutive days as part of the treatment regimen. 2. Have blood samples taken for at least 5 days to monitor viral load, inflammatory markers, and safety parameters. 3. Be monitored by healthcare staff for daily vital signs and symptoms for clinical assessments for 28 days.
Description
Dengue fever is a mosquito-borne viral infection caused by the dengue virus (DENV), which belongs to the Flaviviridae family. It is transmitted primarily by Aedes aegypti and Aedes albopictus mosquitoes. Dengue is recognized as one of the top ten global public health threats, affecting an estimated 390 million people annually, with approximately 96 million cases manifesting clinically. Globally, dengue has seen a significant rise in incidence, with a 30-fold increase in the past 50 years. There is currently no antiviral agent proven to work against it. Dengue fever is endemic in Nepal with cyc…