Clinical Trial:

Copperhead snake bite study

Full Name

Copperhead snake bites/ A Randomized, Double-Blind, Placebo-Controlled Study comparing CroFab® versus Placebo with Rescue Treatment for Copperhead Snake Envenomation (1_PRO00001099)

Description

The use of antivenom for treatment of copperhead snake bites is not always used. This study is being done to find out if people recover better after being bitten by a copperhead snake bite. Copperhead snake bites are rarely deadly. Most people bitten by a copperhead will develop pain and swelling in the limb that is bitten. Patients who choose to take part will be randomly assigned to one of two groups. One group will receive the antivenom called CroFab®. The other group will receive a placebo (looks like the drug, but does not contain an active ingredient). Neither the participant nor their study doctor will know which treatment was received. Participants will be watched for 20-36 hours at the hospital. After leaving the hospital, participants will return 3, 7, 14, 21 and 28 days after the snake bite for a 30-60 minute follow-up visit. Participants will also receive telephone calls 10, 17 and 24 days after the snake bite for a brief 10-15 minute follow-up conversation. Participants will complete various assessments throughout the study.

Eligibility

Inclusion Criteria
  • Must be greater than or equal to 14 years of age
  • Must have been bitten by a copperhead snake
  • Must not be pregnant or breastfeeding
  • Must not have had a previous snake bite to any body area in the 30 days prior to screening/enrollment 
  • Must not have a known hypersensitivity to any component of CroFab®
  • Must not have participated in a clinical study involving an investigational drug or device within 3 months prior to screening that may have an impact on clinical outcomes of snake bites