Emergency Treatment of Coral Snake Envenomation With Antivenom

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%.

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.