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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
First received: May 24, 2013
Last updated: November 16, 2015
Last verified: November 2015
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 versus placebo (no active drug) as measured by the Patient Specific Functional Scale (PSFS) at Day 14 follow-up.

Condition Intervention Phase
Snake Bites
Biological: crotilidae polyvalent immune fab (ovine)
Biological: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Comparing CroFab® Versus Placebo With Rescue Treatment for Copperhead Snake Envenomation

Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Patient Specific Functional Scale at Day 14 [ Time Frame: day 14 ] [ Designated as safety issue: No ]
    compare recovery in copperhead-envenomated patients treated with CroFab® versus placebo, as measured by patient-reported outcome assessment: Patient Specific Functional Scale (PSFS) at Envenomation + Day 14 follow-up.

Estimated Enrollment: 232
Study Start Date: July 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CroFab
crotilidae polyvalent immune fab (ovine) per approved labeling
Biological: crotilidae polyvalent immune fab (ovine)
crotilidae antivenom
Other Name: CroFab
Placebo Comparator: Saline placebo
Saline placebo
Biological: Placebo


Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria-

  • Envenomation by a copperhead snake

    a. Snake identified by one of the following means: i.Snake or photograph of snake brought to Emergency Department ii.Patient chooses copperhead from an array of snake photographs iii.Patient envenomated in an area where only copperheads are endemic iv.Patient envenomated by a captive copperhead snake

  • Completion of informed consent and eligibility confirmation within 24 hours of envenomation
  • Envenomation on only one extremity, distal to the elbow or knee
  • Clinical evidence of mild or moderate venom effect (limb swelling and/or tenderness) is present (Venom effects need not be progressing.)
  • Patient willing and able to complete follow-up schedule of assessments
  • Patient is able to read, comprehend and sign the IRB approved consent document(s)
  • Patient is able to read and comprehend the written assessment tools (e.g., DASH, LEFS, PROMIS Physical Function Short Form 10a (PROMIS PF-10), PGIC, etc.)
  • Patient is ≥12 years of age
  • Patient is sober, competent, and able to complete verbal and written informed consent

Exclusion Criteria-

  • Patient has clinical evidence of severe venom effect as defined by meeting any one of the following parameters:

    i. Swelling to an entire extremity (all major joints affected)

    1. Lower extremity: swelling crossing hip joint
    2. Upper extremity: swelling crossing shoulder joint ii. INR > 2.0 iii. Platelets <50,000 cells / µL iv. Fibrinogen <50 mg/dL

    v. Compartment syndrome vi. Systolic Blood Pressure <90 mmHg vii. More than minimal bleeding viii. Investigator's clinical discretion

  • Patient has already received antivenom for the management of the current envenomation
  • Patient is pregnant or breastfeeding
  • Patient is a prisoner
  • Patient has a distracting injury or condition with acute pain or functional impairment, and/or is unable to make a reliable self-report of functionality status based solely on the condition of interest
  • Patient had a previous snake envenomation to any body area in the 30 days prior to screening/enrollment, regardless of whether antivenom was administered for the previous envenomation
  • Patient had an acute traumatic event, surgery, an acute medical event, or exacerbation of a pre-existing medical or surgical condition affecting the envenomated extremity within the 30 days prior to screening/enrollment
  • Patient has participated in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening that may have impact on clinical outcomes of snakebite
  • Patient has previously participated in this clinical study
  • Patient has a known history of hypersensitivity to any components of CroFab®, or to papaya or papain
  • Patient is otherwise unsuitable for inclusion in this study, based on the opinion of the Investigator
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01864200

United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63130
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
United States, Texas
St Joseph Regional Health
Bryan, Texas, United States, 77802
University of Texas- Southwestern
Dallas, Texas, United States, 75390
Ben Taub General Hospital
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Scott & White Memorial Hospital
Temple, Texas, United States, 76502
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
United States, West Virginia
Marshall Health
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
BTG International Inc.
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01864200     History of Changes
Other Study ID Numbers: BTG-PR005-002
Study First Received: May 24, 2013
Last Updated: November 16, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Snake Bites
Bites and Stings
Chemically-Induced Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2015