Date

2019-06-17

Protocol

Protocol changed

Item Changed

Interventions planned

Previous Version

As mentioned in the original protocol we have recruited patients for the first two groups (patients who will receive 2 vials and 5 vials of the Sri Lankan Antivenom) and the samples were analyzed.

Next Version

As the results of the analysis show complete venom neutralization in all subjects, it was decided not to increase the antivenom dose to 7 or 10 vials per patient. Instead, it has been decided to run the trial with a new dosing level for a group of 20 patients who will receive 1 vial of Sri Lankan antivenom each.