Emergency Treatment of Coral Snake Envenomation With Antivenom

University of Arizona

Status and phase: Completed; Phase 3

Conditions: Toxic Effect of Coral Snake Venom; Coral Snake Bite

Treatments: Drug: Snake (Micrurus) North American immune F(ab')2 Equine

Study type: Interventional

Funder types: Other

Identifiers

NCT01337245

FD003706 (Other Grant/Funding Number)

CS-02/08

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 26 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Antivenom

Experimental group

Description:

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.

Treatment:

Drug: Snake (Micrurus) North American immune F(ab')2 Equine