Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite
United States95 participantsStarted 2021-08-15
Plain-language summary
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.
Who can participate
Age range5 Years
SexALL
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Inclusion criteria
✓. Is a male or female subject ≥ 5 years of age with venomous snakebite and must present with an initial SSS of
✓. 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:
✓. Is willing (or legally authorized representative is willing) to provide informed consent prior to initiation of any study procedures.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in the Combined Pulmonary, Cardiovascular, Hematologic, Nervous System, and Renal Subscores of the Snakebite Severity Score (SSS)
Timeframe: Baseline to 6 and 9 hours after first dose