SnakebitePhase 2BRAVIONCT05717062
Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)
A Phase 2 study testing Varespladib intravenous form and varespladib-methyl- oral form in people with Snakebite and Envenoming, Snake, run by Ophirex, Inc. at 10 sites in United States.
Trial summary
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snakebite, Envenoming, Snake
- What is being tested?
- Varespladib intravenous form and varespladib-methyl- oral form
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 May 2023to 24 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a male or female ≥ 18 years of age with venomous snakebite.
- Patients must have known or suspected venomous snakebite. In India, enrollment will be restricted to patients bitten by suspected or confirmed Russell's viper (Daboia russelii) or krait (Bungarus spp.) In the U.S., any snakebite that meets all other criteria may be eligible.
- Participants must meet one of two categories of inclusion criteria:
- Category 1: The participant is enrolled within 5 hours of venomous snakebite or symptom onset with an SSS score of ≥2 in one system and ≥1 in another system (2+1).
- OR
- Category 2: The participant has a suspected or confirmed bite from an elapid and is enrolled within 10 hours of bite or symptom onset with moderate to severe cranial nerve or skeletal muscle weakness.
- Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.
Who cannot join
- Has history of or is suspected to have CVA or intracranial bleeding of any kind, acute coronary syndrome, MI, or severe pulmonary hypertension.
- Has known history of inherited bleeding or coagulation disorder.
- Is, at Screening Visit, using the following anticoagulants: warfarin/coumadin, argatroban, bilvalirudin, lepirudin, apixaban, dabigatran, clopidogrel, prasugrel, ticlodipine or another anticoagulant agent not specifically listed, or has used heparin, enoxaparin, fondaparinux, or other low molecular weight heparin or any antiarrhythmic drugs within 14 days prior to treatment.
- Has a history of chronic liver disease such as chronic active viral hepatitis, alcohol- related liver disease, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis.
- Reports or has known pre-existing renal impairment or chronic kidney disease.
- Has a known allergy or significant adverse reaction to varespladib or varespladib-methyl.
- Is considered by the Investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns.
- Is pregnant, has a positive serum human chorionic gonadotropin (hCG) pregnancy test or not willing to use a highly effective method of contraception for 14 days after initial treatment, or is breast-feeding.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Duke University Medical Center
Durham, North Carolina, 27710
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
UF Health Shands Hospital
Gainesville, Florida, 32610
Emergency Medicine, University of Kentucky
Lexington, Kentucky, 40536
Desert Regional Medical Center
Palm Springs, California, 92262
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006
Antelope Valley Medical Center
Rosamond, California, 93560
UT Health San Antonio
San Antonio, Texas, 78229
University of South Florida/Tampa General Hospital
Tampa, Florida, 33606
Arizona Poison & Drug Information Center
Tucson, Arizona, 85721
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Varespladib Followed by Oral Varespladib in Addition to Standard of Care in Subjects Bitten by Venomous Snakes
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes.
Note: Funding Source - FDA-OOPD
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of intravenous varespladib followed by oral varespladib, concurrently with standard of care (SOC), in participants bitten by venomous snakes.
Approximately 140 male and female eligible participants will be enrolled and randomized to receive active varespladib or placebo (in addition to SOC)
Randomization will be stratified by the presence or absence of neurotoxicity (SSS nervous system subscore of 0-1 or ≥ 2) at Baseline, and by receipt of antivenom prior to screening, resulting in 4 strata in total.
- Conditions
- Snakebite, Envenoming, Snake
- Being tested
- Varespladib intravenous form, varespladib-methyl- oral form, Placebo intravenous form, Placebo - oral form
- Keywords
- Envenoming, Snakebite, varespladib, antidote, snake
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varespladib intravenous formDrug
Also called LY315920
This is a lyophilized drug contained in 100 mg vials to be reconstituted in Water for Injection (WFI), followed by dilution into 0.9% Sodium Chloride Injection.
varespladib-methyl- oral formDrug
Also called LY333013
Varespladib-methyl (LY333013) is an immediate-release, oval, white, film-coated tablet at a dosage strength of 250 mg for oral administration.
Placebo intravenous formDrug
The intravenous placebo will be saline (0.9%). Blinding will be ensured by covering the bag containing the investigational product with opaque covers.
Placebo - oral formDrug
Oral placebo is supplied as a white film-coated oval tablet to match the appearance of the LY333013 250 mg tablet and contains a subset of the excipients present in the active tablet formulation: lactose monohydrate, microcrystalline cellulose, and magnesium stearate
| Study group | Role | What they receive |
|---|---|---|
| Varespladib Intravenous Form (IV) + Varespladib Oral tablet (LY315920) + SOC | Experimental | Participants will receive intravenous (IV) infusion of varespladib at dose of 0.45 milligrams per kilogram per hour (mg/kg/hr) for six hours. This infusion will continue until when the participant meets clinical criteria for transition to oral drug, -If criteria are met, they will be transitioned to varespladib-methyl (initial dose of 500 mg) then continued oral dosing q12 (once every 12 hours) of 250 mg for the remainder of the study period. Participants that do not meet the criteria for transitioning to the oral drug will remain on the IV infusion at 0.45 mg/kg/hr (along with SOC) and assessed twice a day until they meet criteria for transition to oral drug. Receives: Drug: Varespladib intravenous form; Drug: varespladib-methyl- oral form |
| Placebo Intravenous (IV) + Placebo Oral + SOC | Active comparator | Participants will receive intravenous (IV) infusion of placebo matched to varespladib for six hours. This infusion will continue until the participant meets clinical criteria for transition to oral drug. If criteria are met, they will be transitioned to the oral placebo then continued oral dosing for the remainder of the study period. Participants that do not meet the criteria for transitioning to the oral drug will remain on the IV infusion (along with SOC) and assessed twice a day until they meet criteria for transition to oral drug. Receives: Drug: Placebo intravenous form; Drug: Placebo - oral form |
What is being measured
The primary outcome is the main question the study is designed to answer.
For subjects bitten by vipers: Area Under the Curve (AUC) of an abbreviated Snakebite Severity Score
For subjects bitten by vipers: Area Under the Curve (AUC) of an abbreviated Snakebite Severity Score (SSS) composed of local wound, hematologic, and neurologic subscores from Baseline (pre-dosing) to Day 14.
The independent p-values from subjects bitten by elapids and subjects bitten by vipers will be analyzed using Fisher's combined probability test to obtain a single global p-value for testing the primary endpoint.
The Snakebite Severity Scale is a tool used to measure the severity of envenoming, a higher score indicates worse symptoms.
Measured: Baseline to Day 14
For subjects bitten by elapids: Time to complete head-lift recovery defined by a 5-second head-lift of 5 seconds.
The independent p-values from subjects bitten by elapids and subjects bitten by vipers will be analyzed using Fisher's combined probability test to obtain a single global p-value for testing the primary endpoint.
Measured: Baseline to Day 14
Secondary outcomes (5)
Area under the curve of the composite outcome of pulmonary, cardiovascular, local wound, hematologic, renal, and nervous system sections of the SSS from Baseline to Day 7, among patients randomized within 5 hours from bite.
The SSS is a tool developed to measure the severity of snakebite envenoming. Each category is graded from 0 to 3 or 4 (depending on the body category) and a higher score indicates worse signs or symptoms.
Measured: Baseline to Day 7
Patient Specific Functional Scale (PSFS) score at Day 3 and Day 7.
Patient Specific Functional Scale (PSFS) is a brief, interview-format questionnaire that is used to assess functional disability and any changes in performance of activities. The patient provides 3 activities. The patient then provides a rating for each item on an 11-item ordinal scale, where 0 is "unable to perform activity" and 10 is "able to perform activity at the same level as before injury or problem." The range of possible single activity scores is 0 to 10 and the range of possible total score is 0 to 10 (0 is unable to perform and 10 is perform as before injury/illness).
Measured: Day 3 and Day 7
Complete Snakebite Severity Scale Score (SSS) recovery, from baseline to Day 28.
Complete snakebite severity score (SSS) recovery, defined as a composite score of 0 for the pulmonary, cardiovascular, local wound, hematologic, renal, and nervous system sections of the SSS at Day 28. The SSS is a tool developed to measure the severity of snakebite envenoming. Each category is graded from 0 to 3 or 4 (depending on the body category) and a higher score indicates worse signs or symptoms.
Measured: Baseline through Day 28
Total Antivenom Requirement, measured in number of vials of antivenom administered to the subject, from baseline (pre-dosing) through Day 28
Measured: Baseline through Day 28
Duration of Hospitalization from baseline (pre-dosing) through Day 28
Measured: Baseline through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 May 2023
- Primary completion28 Nov 2024
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SnakebiteStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophirex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Platts-Mills, MD, MSc, Principal investigator, Ophirex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717062
- Sponsor's protocol ID
- OPX-PR-03
- Other IDs
- FD-R-7839
- Acronym
- BRAVIO
- Status last verified
- Jun 2025
- First submitted
- 20 Jan 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woliver C, Kastenholz V, Southern C, Odunayo A, Schaer M, Allen-Durrance A. Phospholipase A2 inhibitor may shorten the duration of clinical signs in the treatment of neurotoxicity caused by eastern coral snake (Micrurus fulvius) envenomation in 3 dogs. J Am Vet Med Assoc. 2025 Jul 30;263(12):1-7. doi: 10.2460/javma.25.04.0275. Print 2025 Dec 1.
PubMed 40738154
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Varespladib Followed by Oral Varespladib in Addition to Standard of Care in Subjects Bitten by Venomous Snakes
- ClinicalTrials.gov ID
- NCT05717062
- Acronym / sponsor ID
- BRAVIO / OPX-PR-03
- Conditions
- Snakebite, Envenoming, Snake
- Keywords
- Envenoming, Snakebite, varespladib, antidote, snake
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ophirex, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes.
Note: Funding Source - FDA-OOPD
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of intravenous varespladib followed by oral varespladib, concurrently with standard of care (SOC), in participants bitten by venomous snakes.
Approximately 140 male and female eligible participants will be enrolled and randomized to receive active varespladib or placebo (in addition to SOC)
Randomization will be stratified by the presence or absence of neurotoxicity (SSS nervous system subscore of 0-1 or ≥ 2) at Baseline, and by receipt of antivenom prior to screening, resulting in 4 strata in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varespladib Intravenous Form (IV) + Varespladib Oral tablet (LY315920) + SOC | Experimental | Drug: Varespladib intravenous form, Drug: varespladib-methyl- oral formParticipants will receive intravenous (IV) infusion of varespladib at dose of 0.45 milligrams per kilogram per hour (mg/kg/hr) for six hours. This infusion will continue until when the participant meets clinical criteria for transition to oral drug, -If criteria are met, they will be transitioned to varespladib-methyl (initial dose of 500 mg) then continued oral dosing q12 (once every 12 hours) of 250 mg for the remainder of the study period. Participants that do not meet the criteria for transitioning to the oral drug will remain on the IV infusion at 0.45 mg/kg/hr (along with SOC) and assessed twice a day until they meet criteria for transition to oral drug. |
| Placebo Intravenous (IV) + Placebo Oral + SOC | Active comparator | Drug: Placebo intravenous form, Drug: Placebo - oral formParticipants will receive intravenous (IV) infusion of placebo matched to varespladib for six hours. This infusion will continue until the participant meets clinical criteria for transition to oral drug. If criteria are met, they will be transitioned to the oral placebo then continued oral dosing for the remainder of the study period. Participants that do not meet the criteria for transitioning to the oral drug will remain on the IV infusion (along with SOC) and assessed twice a day until they meet criteria for transition to oral drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is a male or female ≥ 18 years of age with venomous snakebite.
- Patients must have known or suspected venomous snakebite. In India, enrollment will be restricted to patients bitten by suspected or confirmed Russell's viper (Daboia russelii) or krait (Bungarus spp.) In the U.S., any snakebite that meets all other criteria may be eligible.
- Participants must meet one of two categories of inclusion criteria:
- OR
- Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.
Key exclusion criteria (8 listed)
- Has history of or is suspected to have CVA or intracranial bleeding of any kind, acute coronary syndrome, MI, or severe pulmonary hypertension.
- Has known history of inherited bleeding or coagulation disorder.
- Is, at Screening Visit, using the following anticoagulants: warfarin/coumadin, argatroban, bilvalirudin, lepirudin, apixaban, dabigatran, clopidogrel, prasugrel, ticlodipine or another anticoagulant agent not specifically listed, or has used heparin, enoxaparin, fondaparinux, or other low molecular weight heparin or any antiarrhythmic drugs within 14 days prior to treatment.
- Has a history of chronic liver disease such as chronic active viral hepatitis, alcohol- related liver disease, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis.
- Reports or has known pre-existing renal impairment or chronic kidney disease.
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 |
|---|---|---|
| Varespladib intravenous formAlso: LY315920This is a lyophilized drug contained in 100 mg vials to be reconstituted in Water for Injection (WFI), followed by dilution into 0.9% Sodium Chloride Injection. | Drug | Varespladib Intravenous Form (IV) + Varespladib Oral tablet (LY315920) + SOC |
| varespladib-methyl- oral formAlso: LY333013Varespladib-methyl (LY333013) is an immediate-release, oval, white, film-coated tablet at a dosage strength of 250 mg for oral administration. | Drug | Varespladib Intravenous Form (IV) + Varespladib Oral tablet (LY315920) + SOC |
| Placebo intravenous formThe intravenous placebo will be saline (0.9%). Blinding will be ensured by covering the bag containing the investigational product with opaque covers. | Drug | Placebo Intravenous (IV) + Placebo Oral + SOC |
| Placebo - oral formOral placebo is supplied as a white film-coated oval tablet to match the appearance of the LY333013 250 mg tablet and contains a subset of the excipients present in the active tablet formulation: lactose monohydrate, microcrystalline cellulose, and magnesium stearate | Drug | Placebo Intravenous (IV) + Placebo Oral + SOC |
Primary outcome
For subjects bitten by vipers: Area Under the Curve (AUC) of an abbreviated Snakebite Severity Score
Time frame: Baseline to Day 14
For subjects bitten by vipers: Area Under the Curve (AUC) of an abbreviated Snakebite Severity Score (SSS) composed of local wound, hematologic, and neurologic subscores from Baseline (pre-dosing) to Day 14. The independent p-values from subjects bitten by elapids and subjects bitten by vipers will be analyzed using Fisher's combined probability test to obtain a single global p-value for testing the primary endpoint. The Snakebite Severity Scale is a tool used to measure the severity of envenoming, a higher score indicates worse symptoms.
For subjects bitten by elapids: Time to complete head-lift recovery defined by a 5-second head-lift of 5 seconds.
Time frame: Baseline to Day 14
The independent p-values from subjects bitten by elapids and subjects bitten by vipers will be analyzed using Fisher's combined probability test to obtain a single global p-value for testing the primary endpoint.
5 secondary outcomes
Area under the curve of the composite outcome of pulmonary, cardiovascular, local wound, hematologic, renal, and nervous system sections of the SSS from Baseline to Day 7, among patients randomized within 5 hours from bite.
Time frame: Baseline to Day 7
Patient Specific Functional Scale (PSFS) score at Day 3 and Day 7.
Time frame: Day 3 and Day 7
Complete Snakebite Severity Scale Score (SSS) recovery, from baseline to Day 28.
Time frame: Baseline through Day 28
Total Antivenom Requirement, measured in number of vials of antivenom administered to the subject, from baseline (pre-dosing) through Day 28
Time frame: Baseline through Day 28
Duration of Hospitalization from baseline (pre-dosing) through Day 28
Time frame: Baseline through Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 40738154Woliver C, Kastenholz V, Southern C, Odunayo A, Schaer M, Allen-Durrance A. Phospholipase A2 inhibitor may shorten the duration of clinical signs in the treatment of neurotoxicity caused by eastern coral snake (Micrurus fulvius) envenomation in 3 dogs. J Am Vet Med Assoc. 2025 Jul 30;263(12):1-7. doi: 10.2460/javma.25.04.0275. Print 2025 Dec 1.
- Individual participant dataSharing planned: No
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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.
Timothy Platts-Mills, MD, MSc principal investigator
Ophirex, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varespladib intravenous form and varespladib-methyl- oral form in people with Snakebite and Envenoming, Snake, run by Ophirex, Inc. at 10 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 7 inclusion and 8 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
For subjects bitten by vipers: Area Under the Curve (AUC) of an abbreviated Snakebite Severity Score (time frame: Baseline to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717062, which also lists 1 linked publication.
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 27 Jun 2025.