Abstract | INTRODUCTION: METHODS AND ANALYSIS:
BRAVO (Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite) is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety, tolerability, and efficacy of oral varespladib-methyl plus standard of care (SoC) vs. SoC plus placebo in patients presenting with acute SBE by any venomous snake species. Male and female patients 5 years of age and older who meet eligibility criteria will be randomly assigned 1:1 to varespladib-methyl or placebo. The primary outcome is the Snakebite Severity Score (SSS) that has been modified for international use. This composite outcome is based on the sum of the pulmonary, cardiovascular, nervous, hematologic, and renal systems components of the updated SSS. ETHICS AND DISSEMINATION: This protocol was submitted to regulatory authorities in India and the US. A Clinical Trial No Objection Certificate from the India Central Drugs Standard Control Organisation, Drug Controller General-India, and a Notice to Proceed from the US Food and Drug Administration have been obtained. The study protocol was approved by properly constituted, valid institutional review boards or ethics committees at each study site. This study is being conducted in compliance with the April 1996 ICH Guidance for Industry GCP E6, the Integrated Addendum to ICH E6 (R2) of November 2016, and the applicable regulations of the country in which the study is conducted. The trial is registered on Clinical trials.gov, NCT#04996264 and Clinical Trials Registry-India, 2021/07/045079 000062.
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Authors | Rebecca W Carter, Charles J Gerardo, Stephen P Samuel, Surendra Kumar, Suneetha D Kotehal, Partha P Mukherjee, Farshad M Shirazi, Peter D Akpunonu, Chanaveerappa Bammigatti, Ashish Bhalla, Neeraj Manikath, Timothy F Platts-Mills, Matthew R Lewin, BRAVO Study Group |
Journal | Toxins
(Toxins (Basel))
Vol. 15
Issue 1
(12 28 2022)
ISSN: 2072-6651 [Electronic] Switzerland |
PMID | 36668842
(Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.)
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Chemical References |
- varespladib
- tetrachloroisophthalonitrile
- varespladib methyl
- Phospholipases A2, Secretory
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Topics |
- Humans
- Male
- Female
- Snake Bites
(drug therapy)
- Phospholipases A2, Secretory
- Randomized Controlled Trials as Topic
- Multicenter Studies as Topic
- Clinical Trials, Phase II as Topic
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