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

INCLUSION CRITERIA:

1. Is a male or female ≥ 18 years of age with venomous snakebite.

2. Patients must have known or suspected venomous snakebite. In India, enrollment willbe restricted to patients bitten by suspected or confirmed Russell's viper (Daboiarusselii) or krait (Bungarus spp.) In the U.S., any snakebite that meets all othercriteria may be eligible.

3. Participants must meet one of two categories of inclusion criteria:

4. Category 1: The participant is enrolled within 5 hours of venomous snakebite orsymptom onset with an SSS score of ≥2 in one system and ≥1 in another system (2+1).OR

5. Category 2: The participant has a suspected or confirmed bite from an elapidand is enrolled within 10 hours of bite or symptom onset with moderate tosevere cranial nerve or skeletal muscle weakness.

6. Is willing (or legally authorized representative is willing) to provide informedconsent prior to initiation of any study procedures.

EXCLUSION CRITERIA:

1. Has history of or is suspected to have CVA or intracranial bleeding of any kind,acute coronary syndrome, MI, or severe pulmonary hypertension.

2. Has known history of inherited bleeding or coagulation disorder.

3. Is, at Screening Visit, using the following anticoagulants: warfarin/coumadin,argatroban, bilvalirudin, lepirudin, apixaban, dabigatran, clopidogrel, prasugrel,ticlodipine or another anticoagulant agent not specifically listed, or has usedheparin, enoxaparin, fondaparinux, or other low molecular weight heparin or anyantiarrhythmic drugs within 14 days prior to treatment.

4. Has a history of chronic liver disease such as chronic active viral hepatitis,alcohol- related liver disease, non-alcoholic steatohepatitis, non-alcoholic fattyliver disease, hemochromatosis, primary biliary cirrhosis, primary sclerosingcholangitis, autoimmune hepatitis.

5. Reports or has known pre-existing renal impairment or chronic kidney disease.

6. Has a known allergy or significant adverse reaction to varespladib orvarespladib-methyl.

7. Is considered by the Investigator to be unable to comply with protocol requirementsdue to geographic considerations, psychiatric disorders, or other complianceconcerns.

8. Is pregnant, has a positive serum human chorionic gonadotropin (hCG) pregnancy testor not willing to use a highly effective method of contraception for 14 days afterinitial treatment, or is breast-feeding.