Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation

Exclusion Criteria

• •Patient has clinical evidence of severe venom effect as defined by meeting any one of the following parameters:
• •i. Swelling to an entire extremity (all major joints affected)
• •1. Lower extremity: swelling crossing hip joint
• •2. Upper extremity: swelling crossing shoulder joint ii. INR \> 2.0 iii. Platelets \<50,000 cells / µL iv. Fibrinogen \<50 mg/dL
• •v. Compartment syndrome vi. Systolic Blood Pressure \<90 mmHg vii. More than minimal bleeding viii. Investigator's clinical discretion
• •Patient has already received antivenom for the management of the current envenomation
• •Patient is pregnant or breastfeeding
• •Patient is a prisoner
• •Patient has a distracting injury or condition with acute pain or functional impairment, and/or is unable to make a reliable self-report of functionality status based solely on the condition of interest
• •Patient had a previous snake envenomation to any body area in the 30 days prior to screening/enrollment, regardless of whether antivenom was administered for the previous envenomation
• •Patient had an acute traumatic event, surgery, an acute medical event, or exacerbation of a pre-existing medical or surgical condition affecting the envenomated extremity within the 30 days prior to screening/enrollment
• •Patient has participated in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening that may have impact on clinical outcomes of snakebite
• •Patient has previously participated in this clinical study
• •Patient has a known history of hypersensitivity to any components of CroFab®, or to papaya or papain
• •Patient is otherwise unsuitable for inclusion in this study, based on the opinion of the Investigator