Coral Snake Bite, Toxic Effect of Coral Snake Venom
Conditions
Keywords
Envenomation, Coral Snake, Antivenom, Micrurus fulvius
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%.
Interventions
DRUGSnake (Micrurus) North American immune F(ab')2 Equine
5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Survived | Immediately following start of infusion (day 1) through Day 22 |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antivenom 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.
Snake (Micrurus) North American immune F(ab')2 Equine: 5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Antivenom |
|---|---|
| Age, Continuous | 39.7 years |
| Race/Ethnicity, Customized Race/Ethnicity Black | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 23 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 23 / 26 |
| serious Total, serious adverse events | 3 / 26 |
Outcome results
Primary
Number of Participants Who Survived
Time frame: Immediately following start of infusion (day 1) through Day 22
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antivenom | Number of Participants Who Survived | 25 Participants |
Secondary
Change in Mean Antivenom Level From Baseline to 24 Hours
Time frame: Through 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antivenom | Change in Mean Antivenom Level From Baseline to 24 Hours | 112.4 mcg per ml |
Secondary
Change in Mean Venom Level From Baseline to 24 Hours
Time frame: Through 24 hours
Population: Subjects with blood successfully collected at 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antivenom | Change in Mean Venom Level From Baseline to 24 Hours | -34.5 ng per ml |