Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite

Completed · Phase 2 · Has a placebo group

Conditions studied: Snakebites, Envenoming, Envenoming, Snake, Envenomation, Snake

In brief

This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of varespladib-methyl, concurrently with standard of care (SOC), in subjects bitten by venomous snakes.

Key facts

Study ID

NCT04996264

Run by

Ophirex, Inc.

People needed

95

Starts

2021-08-15

Expected to finish

2023-06-08

Last updated by the study team

2025-07-01

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• SSS scoring should be performed for inclusion assessment without waiting for receipt of Baseline hematological laboratory results. Gastrointestinal scores should not be used for inclusion.
• Index event (snakebite) must be symptomatic and must have occurred within 10 hours of eligibility assessment.
• Must meet one of two categories of inclusion criteria:
• Category 1: The patient has not yet completed first dose of antivenom:
• SSS inclusion score* of ≥2 in one system and ≥1 in another system (2+1) OR ≥3 in at least one system.
• OR
• Category 2: The patient has completed an initial dose of antivenom:
• SSS inclusion score* of ≥2 in one system and ≥1 in another system (2+1) OR ≥3 in at least one system AND CGI-I score of ≥5 (i.e., minimally worse, much worse, or very much worse).
• Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.

You may not qualify if…

• Has received antivenom treatment for envenoming prior to enrollment in this study.
• Is considered by the investigator to have a clinically significant upper GI bleed evidenced by hematemesis, "coffee-ground" emesis or nasogastric aspirate, or hematochezia thought to originate from upper GI tract.
• Has history of cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, or severe pulmonary hypertension.
• Has known history of inherited bleeding or coagulation disorder.
• Is, at Screening Visit, using the following anticoagulants: warfarin/coumadin, argatroban, bivalirudin, lepirudin, apixaban, dabigatran, clopidogrel, prasugrel, ticlopidine or another anticoagulant agent not specifically listed, or has used heparin, enoxaparin, fondaparinux, or other low molecular weight heparin or 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, or autoimmune hepatitis.
• Reports or has known pre-existing renal impairment or chronic kidney disease (defined as Stage 4 or receiving dialysis or hemofiltration).
• Has a known allergy or significant adverse reaction to varespladib-methyl or related compounds.
• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• University of Florida Health — Jacksonville, Florida, United States
• Agusta University Medical Center — Augusta, Georgia, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• LSU LA Poison Control Center — Shreveport, Louisiana, United States
• University of Mississippi Medical Center - Jackson — Jackson, Mississippi, United States
• Duke University Hospital Durham, NC — Durham, North Carolina, United States
• Government medical College — Kozhikode, Calicut, India
• Father Muller medical College Hospital — Mangalore, Karnataka, India
• K R Hospital Mysore medical College and Research Institute — Mysore, Karnataka, India
• Jubilee Mission Medical College and Research Institute — Thrissur, Kerala, India
• Jawaharlal Institute of Postgraduate Medical Education & Research — Puducherry, Puducherry, India
• S.P. Medical College Snakebite Research Cell — Bikaner, Rajasthan, India
• Calcutta National Medical College — Kolkata, West Bengal, India
• Postgraduate Institute of Medical Education and Research — Chandigarh, India

Full record on ClinicalTrials.gov

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