Emergency Treatment of Coral Snake Envenomation With Antivenom

Study Overview
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Brief Summary
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The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and death from the bite of a coral snake. Funding Source - FDA OOPD.

Detailed Description
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Coral snake bites may be trivial in effect, or they may cause profound and life-threatening respiratory paralysis, depending on the severity of the envenomation. Venom toxins target the neuromuscular junction, where effects typically become apparent hours following the bite, by which time the clinical syndrome may be irreversible. Unless neurotoxicity is prevented, ventilatory paralysis may cause death or require intensive care for weeks after the bite. Prevention of paralysis, historically, has involved treating all bite victims with antivenom. This protocol will enable the therapeutic use of a new F(ab')2 antivenom in the management of coral snake envenomation. Following a coral snake bite, patients who meet inclusion/exclusion criteria and who provide informed consent will receive 5 vials of antivenom intravenously over no less than 30 minutes. Blood assays for venom levels and clinical assessments of neurologic status before and after treatment will be conducted and patients will be followed for 22 days for safety and survival endpoints. The primary endpoint of this Phase 3 trial will be survival, for comparison with a historical mortality rate of 15%.

Official Title
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Emergency Treatment of Coral Snake Envenomation With Antivenom

Conditions
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Coral Snake Bite, Toxic Effect of Coral Snake Venom

Intervention / Treatment
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* Drug: Snake (Micrurus) North American immune F(ab')2 Equine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of any age. Presenting for emergency treatment of coral snake bite. Exclusion Criteria: Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antivenom<br>For comparison with historical mortality rate, all patients prospectively enrolled will receive antivenom (Snake [Micrurus] North American immune F(ab')2 Equine) for treatment of coral snake bite. | Drug: Snake (Micrurus) North American immune F(ab')2 Equine<br>* 5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Survived |  | Immediately following start of infusion (day 1) through Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Venom Level From Baseline to 24 Hours |  | Through 24 hours | 
| Change in Mean Antivenom Level From Baseline to 24 Hours |  | Through 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Envenomation, Coral Snake, Antivenom, Micrurus fulvius