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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
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 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
73,746 Total Patients Enrolled
Matthew Lewin, MD, PhDPrincipal InvestigatorOphirex, Inc.
~26 spots leftby Jun 2025
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