BRAVIO IV Study

Pictured above (left to right): Emmanuel Chan, Charles Gerardo, Alexander Limkakeng, and Erica Walker

Let us talk about a snakebite research study at Duke University that has led to world-leading enrollment! Clinical research is comprised of studies that use human volunteers to learn more about new medicines, devices, or to learn about mechanisms of safety and efficacy of medicines. Currently we are researching how we can improve the treatment of snakebites. This study, named “BRAVIO IV”, is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and efficacy of intravenous Varespladib followed by oral Varespladib in addition to standard of care in subjects bitten by venomous snakes.

The purpose of this clinical research study is to learn more about the use of an investigational medicine, called Varespladib, for the possible treatment of a snakebite. It will be given along with standard treatment for a snakebite, such as antivenom. It is experimental, meaning that it has not yet been approved by the Food and Drug Administration (FDA) for this treatment. Varespladib has been tested in clinical trials for the treatment of inflammatory conditions and is currently being tested in two different clinical studies for snakebites including the one at Duke.

Snakebites can lead to severe morbidity, disability, and even death. Research helps improve our understanding of the pathophysiology of snake envenomation, leading to the development of better antivenom therapies and medical interventions. This directly contributes to reducing the morbidity and mortality associated with snakebites.

Snakebite studies provide valuable information for educating healthcare professionals, communities, and individuals about snakebite prevention, first aid, and proper medical treatment. Increased awareness can lead to quicker and more appropriate responses to snakebite incidents.
Duke University Hospital along with other hospitals around the world are helping with this issue, especially in regions with high snakebite incidence rates. Research helps us understand the epidemiology, risk factors, and impacts of snakebites on individuals and communities. This knowledge is essential for effective prevention, treatment, and management strategies.

Research can highlight gaps in healthcare infrastructure and accessibility, particularly in rural or underserved areas where snakebites are more common. Identifying these gaps can lead to improvements in healthcare delivery and emergency response systems.

Currently, Duke University is the lead enrolling site in the world! Thanks to the amazing work of the Principal Investigator, Charles Gerardo, MD, and the Duke Emergency Medicine Clinical Research Staff who spend countless hours in the ER to ensure our snakebite patients are receiving exceptional care. The other great addition to this research study is that our very own Residents are helping us advance future medicine. Further benefits include added clinical oversight from local study physician(s), providers, nurses, and research staff, and other medical personnel such as the study sponsor and the Contract Research Organization.

Research is crucial for developing and improving antivenom treatments. Antivenom efficacy can vary based on snake species, geographical location, and variations in venom composition. Studying snake venom and its effects on the human body enables the creation of more targeted and effective antivenom formulations.

Studies like this can contribute to broader scientific knowledge in areas such as toxicology, pharmacology, and immunology. Insights gained from snakebite studies may have applications beyond snakebite treatment. By addressing this critical global health issue, researchers can make a significant positive impact on both human and environmental health.