Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)

STUDY OVERVIEW

This phase 2 multicenter study by Ophirex Inc. aims to assess the safety, tolerability, and efficacy of intravenous varespladib followed by oral varespladib alongside standard of care in individuals bitten by venomous snakes, involving approximately 140 participants randomized to receive either active treatment or placebo.

STUDY GOALS

The goal of this multicenter, randomized, double-blind, placebo-controlled phase 2 study is to evaluate the safety, tolerability, and efficacy of intravenous varespladib followed by oral varespladib alongside standard of care in participants bitten by venomous snakes.

LOCATION

El Paso, Texas: Texas Tech University Health Sciences Center at El Paso

INCLUSION CRITERIA

  • Male or female aged 18 years or older with venomous snakebite.

  • Must have a known or suspected venomous snakebite, restricted in India to Russell's viper (Daboia russelii) or krait (Bungarus spp.), and any snake in the U.S.

  • Must meet one of the following:

    • Category 1: Enrolled within 5 hours of venomous snakebite or symptom onset with SSS score ≥2 in one system and ≥1 in another system.

    • Category 2: Suspected or confirmed elapid bite, enrolled within 10 hours of bite or symptom onset with moderate to severe cranial nerve or skeletal muscle weakness.

  • Willingness to provide informed consent.

EXCLUSION CRITERIA

  • History or suspicion of stroke (CVA), intracranial bleeding, acute coronary syndrome, myocardial infarction (MI), or severe pulmonary hypertension.

  • Known inherited bleeding or coagulation disorder.

  • Use of specific anticoagulants within 14 days prior to treatment.

  • Chronic liver disease.

  • Pre-existing renal impairment or chronic kidney disease.

  • Allergy or significant adverse reaction to varespladib or varespladib-methyl.

  • Inability to comply with protocol due to geographic, psychiatric, or other compliance concerns.

  • Pregnancy, positive pregnancy test, unwillingness to use effective contraception, or breastfeeding.

For more information, visit ClinicalTrials.gov.