← Back to Search

Phospholipase A2 Inhibitor

Varespladib Methyl for Snake Bites (BRAVO Trial)

Phase 2
Waitlist Available
Led By Matthew Lewin, MD, PhD
Research Sponsored by Ophirex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is a male or female subject ≥ 5 years of age with venomous snakebite and must present with an initial SSS of
2 points in any SSS category other than gastrointestinal and 1 or more additional points in any other SSS category other than gastrointestinal or ≥ 3 in any SSS category other than gastrointestinal.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 3, and 7
Awards & highlights

BRAVO Trial Summary

This trial is testing a new drug to see if it's safe and effective for people who have been bitten by venomous snakes.

Eligible Conditions
  • Snake Bites
  • Poisoning

BRAVO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BRAVO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 3, and 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, and 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the combined pulmonary, cardiovascular, hematologic, and nervous system subscores of the snakebite severity score (SSS)
Secondary outcome measures
All-cause mortality
Area Under the Curve (AUC) of the Numeric Pain Rating Scale (NPRS)
Cardiovascular system
+15 more
Other outcome measures
12-lead electrocardiogram (ECG)
Analgesic use
C-reactive protein (CRP) levels
+23 more

BRAVO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Varespladib-methylExperimental Treatment2 Interventions
Varespladib-methyl is an immediate-release (IR), oval, white, film-coated tablet at a dosage strength of 250 mg for oral administration. Scaled pediatric doses of varespladib-methyl are supplied as 50 mg IR capsules for oral administration. Adult subjects will receive an initial loading dose of 500 mg (2 × 250 mg oral tablet) varespladib-methyl upon randomization, followed by dosing with 250 mg varespladib-methyl (1 × 250 mg oral tablet) approximately 12 hours later, and subsequent twice daily (BID) dosing with 1 × 250 mg varespladib-methyl oral tablets for the remainder of the 7-day treatment period. Tablets may be administered via naso- or orogastric tubes in patients requiring mechanical ventilation. Pediatric subjects (5 to < 18 years) will be administered doses of varespladib-methyl determined by allometric scaling, provided as 50 mg capsules. Age-appropriate capsules may be administered via naso- or orogastric tubes in patients requiring mechanical ventilation.
Group II: PlaceboPlacebo Group2 Interventions
The oral placebo is supplied as a white film-coated oval tablet to match the appearance of the varespladib-methyl 250 mg tablet and contains a subset of the excipients present in the active tablet formulation: lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Placebo for scaled pediatric dosing is supplied as an immediate-release capsule to match the varespladib-methyl 50 mg capsule, and contains the excipients lactose monohydrate, microcrystalline cellulose, and magnesium stearate. The dosing of placebo will match that of varespladib-methyl.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varespladib Methyl
2021
Completed Phase 2
~100
Standard of care (SOC)
2016
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

Ophirex, Inc.Lead Sponsor
2 Previous Clinical Trials
158 Total Patients Enrolled
1 Trials studying Snake Bites
140 Patients Enrolled for Snake Bites
Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
69,261 Total Patients Enrolled
Matthew Lewin, MD, PhDPrincipal InvestigatorOphirex, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for the clinical trial?

"Yes, records from clinicaltrials.gov affirm that enrollment for this research trial is still open. The posting was published on the 15th of August 2021 and modified 3 days later; 110 people are planned to be recruited at 8 different locations."

Answered by AI

Has Varespladib Methyl been subjected to any other clinical examinations?

"Varespladib Methyl was initially trialled in 2021 at Westchester Research Center, part of the Westchester General Hospital. 18332 studies have been finalized since then and 2 clinical trials are currently recruiting participants, most notably within Lexington, Kentucky."

Answered by AI

How many locations are conducting this experiment?

"The trial is currently enrolling patients from 8 different medical centres, including the University of Kentucky Chandler Medical Center in Lexington, the University of Mississippi Medical Center - Jackson in Jackson, and Loma Linda University Medical Centre in Loma Linda."

Answered by AI

Is this clinical trial a pioneering endeavor?

"Scientific research into Varespladib Methyl began in 2021, when Ophirex Inc. sponsored a trial with 18 participants. After successful completion of this initial test, Phase 2 approval was granted in the same year. At present time there are two active trials for Varespladib Methyl taking place across 21 cities and two nations."

Answered by AI

What is the participant enrolment rate for this experiment?

"Affirmative. Clinicaltrials.gov data affirms that this clinical trial is actively seeking participants, having been initially posted on August 15th 2021 and last updated 8/18/2022. The study has a target enrolment of 110 patients from 8 medical sites."

Answered by AI

What safety measures have been taken regarding the administration of Varespladib Methyl?

"Although Varespladib Methyl has not been trialled to demonstrate efficacy, there is some evidence suggesting its safety and thus it was assigned a rating of 2."

Answered by AI
Recent research and studies
Journal of Tropical MedicineJournal
Developing Small Molecule Therapeutics for the Initial and Adjunctive Treatment of Snakebite
Bulfone, Tommaso C., Stephen P. Samuel, Philip E. Bickler, and Matthew R. Lewin. 2018. “Developing Small Molecule Therapeutics for the Initial and Adjunctive Treatment of Snakebite”. Journal of Tropical Medicine. Hindawi Limited. doi:10.1155/2018/4320175.
PraxisJournal
CME: giftschlangenbisse in der schweiz
Plate, Andreas, Hugo Kupferschmidt, and Markus Schneemann. 2016. “CME: giftschlangenbisse in der schweiz”. Praxis. Hogrefe Publishing Group. doi:10.1024/1661-8157/a002388.
PediatricsJournal
Childhood Victims of Snakebites: 2000–2013
Schulte, Joann, Kristina Domanski, Eric Anthony Smith, Annelle Menendez, Kurt C. Kleinschmidt, and Brett A. Roth. 2016. “Childhood Victims of Snakebites: 2000–2013”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2016-0491.
Clinical ToxicologyJournal
AAPCC Database Characterization of Native U.S. Venomous Snake Exposures, 2001–2005
Seifert, Steven A., Leslie V. Boyer, Blaine E. Benson, and Jody J. Rogers. 2009. “AAPCC Database Characterization of Native U.S. Venomous Snake Exposures, 2001–2005”. Clinical Toxicology. Informa UK Limited. doi:10.1080/15563650902870277.
~26 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top