Clinical trial

Emergency Treatment of Coral Snake Envenomation With Antivenom

Name

CS-02/08

Description

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.

Trial arms

Trial start

2012-05-01

Estimated PCD

2016-11-11

Trial end

2016-11-11

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Antivenom

Size

Primary endpoint

Number of Participants Who Survived

Immediately following start of infusion (day 1) through Day 22

Eligibility criteria

Inclusion Criteria: * Male or female of any age. Presenting for emergency treatment of coral snake bite. Exclusion Criteria: * Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

Updated at

2023-05-26

1 organization

Organization

University of Arizona