Coral Snake BitePhase 3NCT01337245
Emergency Treatment of Coral Snake Envenomation With Antivenom
A Phase 3 study testing Snake (Micrurus) North American immune F(ab')2 Equine in people with Coral Snake Bite and Toxic Effect of Coral Snake Venom, run by University of Arizona at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coral Snake Bite, Toxic Effect of Coral Snake Venom
- What is being tested?
- Snake (Micrurus) North American immune F(ab')2 Equine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2012to 11 Nov 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female of any age. Presenting for emergency treatment of coral snake bite.
Who cannot join
- Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Florida Hospital Deland
DeLand, Florida, 32720
Lee Memorial Hospital
Fort Myers, Florida, 33901
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952
Tampa General Hospital
Tampa, Florida, 33601-1289
Banner University Medical Center
Tucson, Arizona, 85724
About this study
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.
Read the detailed description
Coral snake bites may be trivial in effect, or they may cause profound and life-threatening respiratory paralysis, depending on the severity of the envenomation. Venom toxins target the neuromuscular junction, where effects typically become apparent hours following the bite, by which time the clinical syndrome may be irreversible. Unless neurotoxicity is prevented, ventilatory paralysis may cause death or require intensive care for weeks after the bite. Prevention of paralysis, historically, has involved treating all bite victims with antivenom.
This protocol will enable the therapeutic use of a new F(ab')2 antivenom in the management of coral snake envenomation.
Following a coral snake bite, patients who meet inclusion/exclusion criteria and who provide informed consent will receive 5 vials of antivenom intravenously over no less than 30 minutes. Blood assays for venom levels and clinical assessments of neurologic status before and after treatment will be conducted and patients will be followed for 22 days for safety and survival endpoints.
The primary endpoint of this Phase 3 trial will be survival, for comparison with a historical mortality rate of 15%.
- Being tested
- Snake (Micrurus) North American immune F(ab')2 Equine
- Keywords
- Envenomation, Coral Snake, Antivenom, Micrurus fulvius
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snake (Micrurus) North American immune F(ab')2 EquineDrug
5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Antivenom | Experimental | For comparison with historical mortality rate, all patients prospectively enrolled will receive antivenom (Snake [Micrurus] North American immune F(ab')2 Equine) for treatment of coral snake bite. Receives: Drug: Snake (Micrurus) North American immune F(ab')2 Equine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Survived
Measured: Immediately following start of infusion (day 1) through Day 22
Secondary outcomes (2)
Change in Mean Venom Level From Baseline to 24 Hours
Measured: Through 24 hours
Change in Mean Antivenom Level From Baseline to 24 Hours
Measured: Through 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMay 2012
- Primary completion11 Nov 2016
- Study completion11 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coral Snake BiteStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Boyer, MD, Study director, VIPER Institute, University of ArizonaJason W. Wilson, MD, Principal investigator, Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337245
- Sponsor's protocol ID
- CS-02/08
- Other IDs
- FD003706
- Status last verified
- May 2023
- First submitted
- 15 Apr 2011
- Last updated
- 26 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Treatment of Coral Snake Envenomation With Antivenom
- ClinicalTrials.gov ID
- NCT01337245
- Acronym / sponsor ID
- CS-02/08
- Keywords
- Envenomation, Coral Snake, Antivenom, Micrurus fulvius
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Posted 5 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Coral snake bites may be trivial in effect, or they may cause profound and life-threatening respiratory paralysis, depending on the severity of the envenomation. Venom toxins target the neuromuscular junction, where effects typically become apparent hours following the bite, by which time the clinical syndrome may be irreversible. Unless neurotoxicity is prevented, ventilatory paralysis may cause death or require intensive care for weeks after the bite. Prevention of paralysis, historically, has involved treating all bite victims with antivenom.
This protocol will enable the therapeutic use of a new F(ab')2 antivenom in the management of coral snake envenomation.
Following a coral snake bite, patients who meet inclusion/exclusion criteria and who provide informed consent will receive 5 vials of antivenom intravenously over no less than 30 minutes. Blood assays for venom levels and clinical assessments of neurologic status before and after treatment will be conducted and patients will be followed for 22 days for safety and survival endpoints.
The primary endpoint of this Phase 3 trial will be survival, for comparison with a historical mortality rate of 15%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antivenom | Experimental | Drug: Snake (Micrurus) North American immune F(ab')2 EquineFor comparison with historical mortality rate, all patients prospectively enrolled will receive antivenom (Snake [Micrurus] North American immune F(ab')2 Equine) for treatment of coral snake bite. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female of any age. Presenting for emergency treatment of coral snake bite.
Key exclusion criteria (1 listed)
- Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snake (Micrurus) North American immune F(ab')2 Equine5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously. | Drug | Antivenom |
Primary outcome
Number of Participants Who Survived
Time frame: Immediately following start of infusion (day 1) through Day 22
2 secondary outcomes
Change in Mean Venom Level From Baseline to 24 Hours
Time frame: Through 24 hours
Change in Mean Antivenom Level From Baseline to 24 Hours
Time frame: Through 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Boyer, MD study director
VIPER Institute, University of Arizona
Jason W. Wilson, MD principal investigator
Tampa General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Snake (Micrurus) North American immune F(ab')2 Equine in people with Coral Snake Bite and Toxic Effect of Coral Snake Venom, run by University of Arizona at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Survived (time frame: Immediately following start of infusion (day 1) through Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.