A Phase 3 interventional study of Snake (Micrurus) North American immune F(ab')2 Equine in Coral Snake Bite and Toxic Effect of Coral Snake Venom, sponsored by University of Arizona. Completed at 5 sites in United States. Per ClinicalTrials.gov, last updated 2023-05-26.
Sponsored by University of Arizona · Phase 3, Interventional, and Treatment
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.
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%.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's enrollment of 26 is below the median of 70 across 18 interventional studies indexed under Snake Bites.
Browse Snake Bites studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
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
5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.
Number of Participants Who Survived
Time frame: Immediately following start of infusion (day 1) through Day 22
Change in Mean Venom Level From Baseline to 24 Hours
Time frame: Through 24 hours
Change in Mean Antivenom Level From Baseline to 24 Hours
Time frame: Through 24 hours
| Milestone | Antivenom |
|---|---|
| Started | 26 |
| Completed | 25 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
| Participants | Antivenom |
|---|---|
| Number of Participants Who Survived | 25 |
| ng per ml | Antivenom |
|---|---|
| Change in Mean Venom Level From Baseline to 24 Hours | -34.5 (-353 to 0) |
| mcg per ml | Antivenom |
|---|---|
| Change in Mean Antivenom Level From Baseline to 24 Hours | 112.4 (62.6 to 236.4) |
Collected over 22 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antivenom | 0/26 (0%) | 3/26 (11.5%) | 23/26 (88.5%) |
| Event | Antivenom |
|---|---|
| Type I immediate hypersensitivity reactionRespiratory, thoracic and mediastinal disorders | 1/26 |
| Hospital Re-admissionInfections and infestations | 1/26 |
| Alcohol withdrawal resulting in prolonged hospitalizationGeneral disorders | 1/26 |
| Event | Antivenom |
|---|---|
| RashSkin and subcutaneous tissue disorders | 6/26 |
| Acute immune reactionImmune system disorders | 6/26 |
| Musculoskeletal PainMusculoskeletal and connective tissue disorders | 5/26 |
| Local swellingSkin and subcutaneous tissue disorders | 4/26 |
| Muscle weaknessMusculoskeletal and connective tissue disorders | 3/26 |
| Runny noseRespiratory, thoracic and mediastinal disorders | 2/26 |
| LightheadednessNervous system disorders | 2/26 |
| DiarrheaGastrointestinal disorders | 2/26 |
| NumbnessSkin and subcutaneous tissue disorders | 2/26 |
| Shortness of breathRespiratory, thoracic and mediastinal disorders | 2/26 |
| Age, Continuous(years) | Antivenom |
|---|---|
| Mean | 39.7 (11 to 65) |
| Sex: Female, Male(Participants) | Antivenom |
|---|---|
| Female | 1 |
| Male | 25 |
| Race/Ethnicity, Customized(Participants) | Antivenom |
|---|---|
| Race/Ethnicity — White | 23 |
| Race/Ethnicity — Black | 1 |
| Race/Ethnicity — Hispanic | 1 |
| Race/Ethnicity — Unknown | 1 |
| Region of Enrollment(participants) | Antivenom |
|---|---|
| United States | 26 |
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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