Emergency Treatment of Coral Snake Envenomation With Antivenom

Phase 3

Completed

• Conditions: Coral Snake Bite; Toxic Effect of Coral Snake Venom
• Interventions: Drug: Snake (Micrurus) North American immune F(ab')2 Equine

• Registration Number: NCT01337245
• Lead Sponsor: University of Arizona

Brief Summary

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

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%.

Study Timeline

• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Study Start: 2012-05
• Primary Completion: 2016-11-11
• Study Completion: 2016-11-11
• Disposition First Submitted: 2018-05-31
• Disposition First Submitted QC: 2018-06-04
• Disposition First Posted: 2018-06-08
• Results First Submitted: 2023-03-08
• Results First Submitted QC: 2023-03-08
• Results First Posted: 2023-04-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antivenom	Snake (Micrurus) North American immune F(ab')2 Equine	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Survived	Immediately following start of infusion (day 1) through Day 22

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Florida Hospital Deland; 🇺🇸 DeLand, Florida, United States

St. Lucie Medical Center; 🇺🇸 Port Saint Lucie, Florida, United States

Banner University Medical Center; 🇺🇸 Tucson, Arizona, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Lee Memorial Hospital; 🇺🇸 Fort Myers, Florida, United States