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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - Any
Updated:11/24/2017
Start Date:July 2013
End Date:December 2015

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A Randomized, Double-Blind, Placebo-Controlled Study Comparing CroFab® vs Placebo With Rescue Treatment for Copperhead Snake Envenomation

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.

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.

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
We found this trial at
18
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Dallas, Texas 75390
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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1200 South Cedar Crest Boulevard
Allentown, Pennsylvania 18103
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Bryan, TX
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Greenville, North Carolina 27834
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
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Huntington, West Virginia 25701
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Kansas City, Kansas 66160
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Saint Louis, Missouri 63110
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Temple, Texas 76508
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