Randomized, Double-Blind, Placebo-Controlled Study: CroFab® vs Placebo for Copperhead Snake Envenomation

Phase 4

Completed

Interventions: Biological: Placebo
Biological: Crotalidae polyvalent immune fab (ovine)

Brief Summary: This study will evaluate the recovery from copperhead snake bite in patients with mild or moderate venom effect. Potential subjects received CroFab antivenom or placebo. After blinded treatment and discharge, the subject returns to the clinic for follow-up assessments at day 3, 7, 14, and 28 after snake bite as well as follow-up telephone assessments on day 10, 17, and 24 after snake bite. The purpose of this study is to compare recovery in copperhead snake bite patients treated with antivenom vs placebo (no active drug) as measured by the Patient Specific Functional Scale (PSFS) at Day 14 follow-up. The primary efficacy endpoint of this study was achieved.

Detailed Description: This study will evaluate the recovery from copperhead snake bite in patients with mild or moderate venom effect. Potential subjects will receive CroFab antivenom or placebo. The trial is conducted by emergency room doctors, toxicologists, or surgeons at hospitals in regions where copperhead bites are common. After blinded treatment and discharge, the subject returns to the clinic for follow-up assessments at day 3, 7, 14, and 28 after snake bite. The subject will also be called by telephone for follow-up assessments on day 10, 17, and 24 after snake bite. The purpose of this study is to compare recovery in copperhead snake bite patients treated with antivenom vs placebo (no active drug) as measured by the Patient Specific Functional Scale (PSFS) at Day 14 follow-up.The primary efficacy endpoint of this study was achieved. Treatment with CroFab® demonstrated measurable and significant improvement (less disability) over placebo: in the mITT population, the LS mean total score on the PSFS at Day 14 follow-up and treatment showed less disability in patients randomized to receive CroFab® than those receiving placebo.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Saline placebo	Placebo	Saline placebo
CroFab	Crotalidae polyvalent immune fab (ovine)	crotalidae polyvalent immune fab (ovine) per approved labeling

Primary Outcome Measures

Name	Time	Method
Patient Specific Functional Scale Score	at 14 day follow-up	Patient Specific Functional Scale (PSFS) at 14 day follow-up This is a three-item instrument, administered verbally, that is used to evaluate whether a health condition impacts a patient's ability to perform activities that are important to him/her. On the initial assessment, the patient is asked to identify "up to three important activities that you are unable to do or are having difficulty with as a result of your (snakebite)." The patient then provides a rating for each item, on an 11-point ordinal scale ranging from 0 ("unable to perform activity") to 10 ("able to perform activity at the same level as before the injury or problem"). During reassessments, the subject is prompted to re-rate the same three activities. The average of up to 3 specific activity scores was recorded, and the range of possible scores is 0 - 10. Higher scores indicate less impairment.

Secondary Outcome Measures

Name	Time	Method

Locations (18): Georgia Regents University
🇺🇸
Augusta, Georgia, United States
St Joseph Regional Health Center
🇺🇸
Bryan, Texas, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Vidant Medical Center
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Greenville, North Carolina, United States
Lehigh Valley Hospital Center
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Allentown, Pennsylvania, United States
Virginia Commonwealth University
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Richmond, Virginia, United States
Palmetto Health Richland
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Columbia, South Carolina, United States
University of Texas - Southwestern
🇺🇸
Dallas, Texas, United States
Scott & White Hospital
🇺🇸
Temple, Texas, United States
Washington University
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Saint Louis, Missouri, United States
University of Kansas Hospital
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Kansas City, Kansas, United States
University of Pittsburgh
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Pittsburgh, Pennsylvania, United States
University of Virginia
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Charlottesville, Virginia, United States
Marshall Health
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Huntington, West Virginia, United States
University of North Carolina
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Chapel Hill, North Carolina, United States
Ben Taub General Hospital
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Houston, Texas, United States
Duke University
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Durham, North Carolina, United States
Texas Children's Hospital
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Houston, Texas, United States