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 (BRAVO study – Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite)

About this Study

The purpose of this clinical research study is to learn more about the use of the study medicine, varespladib, for the treatment of snakebite. You or your child will receive a medication called Varespladib or placebo. Varespladib is an experimental treatment, meaning that it has not yet been approved by the Food and Drug Administration (FDA) for the treatment of snakebite.  In this study, varespladib will be compared to a placebo.  A placebo is a pill that looks exactly like the study medicine but does not contain any active ingredient, and has no therapeutic effect by itself.

Sponsor Protocol ID:OPX-PR-01
IRB Number:2021-1045
Actively Enrolling
Phase 2
January 24, 2022
Eligibility Criteria
5 years old
Both Male and Female

Inclusion Criteria
  • Male or female must be 5 years of age or older with venous snakebite and SSS score of 2 or 3
  • Snakebite must have occurred within 8 hours of eligibility assessment
  • Must have symptoms from snakebite
  • Must be willing to sign informed consent document before any study procedures

Exclusion Criteria
  • Has received antivenom treatment prior to enrollment in the study
  • Having clinically significant upper GI bleed (vomiting blood, "coffee-ground" vomitus)
  • History of stroke or bleeding within the skull, decreased blood flow in the coronary arties, heart attack, or pulmonary hypertension
  • History of inherited bleeding or coagulation disorder
  • Taking anticoagulants (blood thinners) at time of screening for study
  • History of chronic liver disease
  • Known pre-existing renal impairment or chronic kidney disease
  • Known allergy or prior significant reaction to varespladib-methyl
  • Pregnant