A study of Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite (BRAVO).

Phase 2

Completed

• Conditions: Toxic effect of snake venom,

• Registration Number: CTRI/2021/11/037901
• Lead Sponsor: Ophirex Inc

Brief Summary

A study is Randomized, Double-Blinded, Placebo-Controlled Add-On Therapy 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-02
• Study Completion: 2022-12-13
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Is a male or female ≥ 5 years of age with venomous snakebite and a qualifying SSS inclusion score.
• SSS inclusion categories are: local wound, pulmonary, cardiovascular, hematologic, and nervous system.
• Hematologic score may be counted if available, but inclusion should not wait for laboratory results.
• GI or Renal categories will not count for inclusion.
• A qualifying SSS inclusion score may be either: 2 points in any single SSS inclusion category AND at least 1 point in any other SSS inclusion category OR ≥ 3 in any single SSS inclusion category 2.
• Index event (snakebite) must be symptomatic and must have occurred within 8 hours of eligibility assessment.
• Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.

Exclusion Criteria

• Has received antivenom treatment for envenoming prior to enrollment in this study.
• Has an upper gastrointestinal (GI) bleed evidenced by hematemesis, “coffee-ground†emesis or nasogastric spirate, or hematochezia thought to originate from upper GI tract.
• Has history of cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, or severe pulmonary hypertension.
• Has known history of inherited bleeding or coagulation disorder.
• 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 used heparin, enoxaparin, fondaparinux, or other low molecular weight heparin or antiarrhythmic drugs within 14 days prior to treatment.
• Has a history of chronic liver disease such as chronic active viral hepatitis, alcohol-related liver disease, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis.
• Has chronic kidney disease (defined as Stage 4 or receiving dialysis) or acute renal insufficiency with an eGFR < 60 mL/min (including patients receiving hemodialysis or hemofiltration).
• Has a known allergy or significant adverse reaction to varespladib-methyl or related compounds.
• Is considered by the Investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns.
• Is pregnant, has a positive serum human chorionic gonadotropin (hCG) pregnancy test or not willing to use a highly effective method of contraception for 14 days after initial treatment, or is breast-feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of the snakebite severity score (SSS) from Baseline (pre-dosing) to 6 hours after first dose	6 hours after first dose

Secondary Outcome Measures

Name	Time	Method
SSS(pre-dosing) and PGIC from Baseline to Day7 after 1dose	Coagulation abnormalities in patients with SSS hematology score of ≥2 at Baseline to Day7

Trial Locations

Locations (8)

Calcutta National Medical College & Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Father Muller Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

Govt Medical College, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Govt. Medical College, Kozhikode; 🇮🇳 Kozhikode, KERALA, India

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER); 🇮🇳 Pondicherry, PONDICHERRY, India

K R Hospital, attached to Mysore Medical College and Research Institute; 🇮🇳 Mysore, KARNATAKA, India

Post Graduate Institute of Medical Education & Research; 🇮🇳 Chandigarh, CHANDIGARH, India

S.P.Medical College & A. G. of Hospitals; 🇮🇳 Bikaner, RAJASTHAN, India

Calcutta National Medical College & Hospital

🇮🇳Kolkata, WEST BENGAL, India

Dr Partha Pratim Mukherjee

Principal investigator

9830488840

drppmukherjeecnmc@gmail.com