Date

2025-07-20

Protocol

Protocol changed

Item Changed

Target number/sample size

Previous Version

Phase II- Intervention arm- 10, Comparator arm- 10 Phase III Intervention arm- 20, Comparator arm- 20

Next Version

The sample size is 130 participants (100 of Big 4 snakebites and 30 of hump-nosed viper bites). Initially, 40 cases of Big 4 will be recruited, including the intervention arm-20 and the comparator arm 20. Then, an interim analysis after 40 cases will be done. After that, the remaining 60 will be recruited as the intervention arm-30 and the comparator arm-30. For the dose finding study, 30 cases of HNV bites that will require AVS during this one year will be recruited.