Phase II Clinical Trial to Establish Efficacy of a Locally Appropriate Bivalent Anti Snake Venom in Pakistan
Pages 100-105
Naeem Quraishi, Tasneem Ahmad, Allah-Bux Ghanghro, Abdullah Arejo, Sharib S. Muhammad and Atta Chandio
DOI: http://dx.doi.org/10.6000/1927-5951.2017.07.03.5
Published: 14 July 2017

Abstract:  Objective: This study was conducted to determine the efficacy of Snake anti-venom Immunoglobulin [IgG] manufactured by Anti-Snake Venom [ASV]/Anti-Rabies [ARV] Serology Laboratory, Health Department, Government of Sindh.

Methods: The prospective, observational single arm study was conducted after the approval of IRB. Study included six patients with viper [Echis carinatus sochureki] snakebites referred to the emergency ward of Peoples University of Medical & Health Sciences Hospital, Nawabshah and District Headquarter Hospital Mithi, Sindh, Pakistan with consultation of Clinical and Principal investigator. The study was conducted over a period of three months [August 2015 to November 2015]. All patients were given IV infusion of 10 mL [1 vial] investigational ASV diluted in 100 mL normal saline except one patient who received 5 mL management dose and 5 mL subsequent dose for the recovery of coagulopathy. The efficacy was assessed by Primary and secondary efficacy endpoints, i.e. the dose at which maximum no of patients were treated [permanent restoration of normal blood coagulation tested by 20-minute whole blood clotting test [20-minute WBCT] with minimum toxicity.

Results: All patients recovered from coagulopathy after receiving IV infusion of 10 mL investigational ASV diluted in 100 mL normal saline tested by 20-minute WBCT. Mean Recovery time was 9:15 ± 3:25 hours.

Conclusion: Safety and efficacy was assessed for the Bivalent Anti venom Immunoglobulin-NQ1 [IgG] manufactured by ASV/ARV Serology Laboratory, Health Department, Government of Sindh..

Keywords:
Immunoglobulin [IgG], anti-snake venom [ASV], 20-minute WBCT, Echis carinatus sochureki [Lundi], Coagulopathy

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