BRAVO study - Broad spectrum Rapid Antidote: Varespladib Oral for snakebite - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see how an investigational drug, Varespladib, works in your body and against symptoms from snake venom.

What is the Condition Being Studied?

Snake bites

Who Can Participate in the Study?

Adults who:
- Have been bitten by a venomous snake
- Are having symptoms

Age Group
Adults

What is Involved?

If you choose to be in this study, you will:
- Be randomly assigned (like flipping a coin) to 1 of 2 groups
-- Group 1: Take the study drug by mouth for 7 days
-- Group 2: Take a placebo (harmless, inactive substance) by mouth for 7 days
- Have physical exams, blood draws, and urine tests
- Have electrocardiograms (ECG), scans to look at your heart
- Complete surveys about your symptoms and recovery

Study Details

Full Title
Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of a Multi-Dose Regimen of Oral Varespladib-Methyl in Subjects Bitten by Venomous Snakes
Principal Investigator
Emergency Medicine Specialist
Protocol Number
IRB: PRO00108196
NCT: NCT04996264
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698