Slctr

A Phase II/III randomized, controlled, open labelled study to evaluate the safety and efficacy of snake venom antiserum – Sri Lanka (SL-AVS) developed for Sri Lankan species vs currently used anti snake venom.

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SLCTR Registration Number

SLCTR/2023/002

Date of Registration

02 Mar 2023

The date of last modification

Mar 02, 2023

Application Summary

Scientific Title of Trial

A Phase II/III randomized, controlled, open labelled study to evaluate the safety and efficacy of snake venom antiserum – Sri Lanka (SL-AVS) developed for Sri Lankan species vs currently used anti snake venom.

Public Title of Trial

Open labelled study to evaluate the safety and efficacy of snake venom antiserum – Sri Lanka (SL-AVS) developed for Sri Lankan species vs currently used anti snake venom in patients with patients with snake bite.

Disease or Health Condition(s) Studied

Snakebite envenomation

Scientific Acronym

None

Public Acronym

None

Brief title

A Sri Lankan antivenom trial

Universal Trial Number

U1111-1287-6071

Any other number(s) assigned to the trial and issuing authority

2022/EC/29 (University of Peradeniya)

Trial Details

What is the research question being addressed?

Is a new Sri Lankan antivenom (SL-AVS) developed for Sri Lankan species safe and efficacious compared to the currently used anti snake venom in patients with snakebite?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Single blinded : Participants, Data analysts

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 2-3

Intervention(s) planned

The study will be conducted in Medical wards of 3 selected centers in Sri Lanka- TH Anuradhapura, TH- Rathnapura, BH- Kilinochch At first, about 20 patients with snakebite eligible to receive ASV will be randomized for a safety study of the candidate ASV. Having established the safety, the study will enroll a further 40 patients. Patients who attend the hospital emergency and are clinically eligible to receive ASV will be stabilized and then administered ASV intravenously. Investigations and management will be as per standard of care, till the discharge of the patient Method of randomization: block randomization (blocks of 4). Intervention- Snake Venom Antiserum, I.P. is a sterile solution containing enzyme refined anti snake venom equine immunoglobulin F(ab’)2 fragments for parenteral administration. Snake Venom Antiserum is supplied in 10 ml glass vial with 10 ml sterile water for injection, as diluent. The diluent will be withdrawn in to a 10 ml sterile syringe and the needle inserted through the vial stopper and injected to the powder. The contents will be mixed gently by a swirling action. The serum will be used as soon as possible after reconstitution. Administration is by slow IV infusion over one hour. The dose (number of vials used and frequency) will depend on envenomation. Comparator- ANTI-SNAKE VENOM SERUM, I.P. (ASVS).

Inclusion criteria

• Any patient of either sex, • Age between 18 and 60 years • Patients reporting with the history of confirmed snakebite, • SL-ASV will be administered only for systemic envenoming effects except local manifestations of confirmed cobra bites. The systemic envenoming effects are as follows: 1. Neurotoxic envenomation- Patients with ptosis, external ophthalmoplegia and respiratory failure 2. Haemotoxic envenomation- Patient presenting with bleeding manifestations with laboratory confirmation of coagulopathy such as WBCT >20 minutes (Whole Blood Clotting Test), elevated PT/INR and APTT. Local effects are as follows: 1. Patients presenting with local pain, swelling and necrosis following only for confirmed cobra bites. • Following are the criteria/indications for giving SL-ASV for hump- nosed viper bites 1 Patients with positive WBCT20 and or elevated PT/INR (VICC) . 2. Patients with oliguria/anuria (UOP < 0.5 mL/kg/hr for 6 hrs) or increased serum creatinine (> 27 µmol/L relative to a known base line value within 48 hrs/ or clinical diagnosis) [acute kidney injury]

Exclusion criteria

• Pre-existing renal disease, uncontrolled chronic obstructive airway disease, congestive heart failure and previous myocardial infarction • Patients taking diuretics, anticoagulants and antiplatelet drugs • Pregnant mothers

Primary outcome(s)

1. Improvement in clinical criteria 1. Improvement of bleeding manifestations 2. Improvement of neurological manifestations (neck muscle power/improvement of ophthalmoplegia/ptosis) 3. Improvement of renal manifestations (urine output) 4. Improvement of local reaction	[ Post AVS at 1 hour, 6 hours, 24 hours, and 48 hours. ]
2. Improvement in laboratory criteria: 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) 3. Improvement of renal abnormalities (Serum creatinine) 4. Improvement of inflammatory response (white cell count/C-reactive protein)	[ Post AVS at 1 hour, 6 hours, 24 hours, and 48 hours. ]
3. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[ Post AVS at 1 hour, 6 hours, 24 hours, and 48 hours ]
4. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
5. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
6. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
7. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
8. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
9. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
10. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
11. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
12. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
13. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
14. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
15. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
16. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
17. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
18. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
19. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
20. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
21. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
22. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
23. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
24. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
25. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
26. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
27. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
28. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
29. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
30. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
31. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
32. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
33. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
34. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
35. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
36. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
37. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
38. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
39. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
40. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
41. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
42. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
43. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
44. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
45. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
46. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
47. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
48. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
49. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
50. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
51. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
52. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
53. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
54. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
55. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
56. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
57. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
58. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
59. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
60. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
61. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
62. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
63. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
64. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
65. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
66. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
67. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
68. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
69. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
70. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
71. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
72. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
73. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
74. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
75. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
76. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
77. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
78. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
79. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
80. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
81. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
82. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
83. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
84. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
85. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
86. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
87. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
88. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
89. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
90. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
91. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
92. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
93. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]
94. Improvement in laboratory criteria 1. Improvement and time taken for improvement of coagulopathy 2. Improvement on hematological abnormalities (Platelets/MAHA in blood picture) Improvement of renal abnormalities (Serum creatinine) 3. Improvement of inflammatory response (white cell count/C-reactive protein).	[]
95. Safety measures will be assessed by grade referred to the severity of the Adverse reactions. Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be used to grade adverse reactions.	[]

Secondary outcome(s)

1. Total dose of SL-ASV used to achieve clinical improvement	[]
2. Total time required for clinical recovery and discontinuation of SL-ASV	[]
3. Total duration of hospital stay	[]
4. Total time required for clinical recovery and discontinuation of SL-ASV	[]
5. Total duration of hospital stay.	[]
6. Number of cases suffering complications of snakebite	[]
7. Total time required for clinical recovery and discontinuation of SL-ASV	[]
8. Total duration of hospital stay.	[]
9. Number of cases suffering complications of snakebite	[]
10. Total time required for clinical recovery and discontinuation of SL-ASV	[]
11. Total duration of hospital stay.	[]
12. Number of cases suffering complications of snakebite	[]
13. Total time required for clinical recovery and discontinuation of SL-ASV	[]
14. Total duration of hospital stay.	[]
15. Number of cases suffering complications of snakebite	[]
16. Total time required for clinical recovery and discontinuation of SL-ASV	[]
17. Total duration of hospital stay.	[]
18. Number of cases suffering complications of snakebite	[]
19. Total time required for clinical recovery and discontinuation of SL-ASV	[]
20. Total duration of hospital stay.	[]
21. Number of cases suffering complications of snakebite	[]
22. Total time required for clinical recovery and discontinuation of SL-ASV	[]
23. Total duration of hospital stay.	[]
24. Number of cases suffering complications of snakebite	[]
25. Total time required for clinical recovery and discontinuation of SL-ASV	[]
26. Total duration of hospital stay.	[]
27. Number of cases suffering complications of snakebite	[]
28. Total time required for clinical recovery and discontinuation of SL-ASV	[]
29. Total duration of hospital stay.	[]
30. Number of cases suffering complications of snakebite	[]
31. Total time required for clinical recovery and discontinuation of SL-ASV	[]
32. Total duration of hospital stay.	[]
33. Number of cases suffering complications of snakebite	[]

Target number/sample size

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

Countries of recruitment

Sri Lanka

Anticipated start date

2023-04-01

Anticipated end date

2024-04-01

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

George Steuart & Company

Regulatory approvals

State of Ethics Review Approval

Status

Approved

Date of Approval

2022-11-16

Approval number

2022/EC/29

Details of Ethics Review Committee

Name:	Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:	Faculty of Medicine, University of Peradeniya, Peradeniya.
Telephone:	081-2396361
Email:	chairpersonierc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

S.A.M.Kularatne
Senior Professor of Medicine
Faculty of Medicine, University of Peradeniya, Peradeniya

0773420771

tbn1917@gmail.com

Contact Person for Public Queries

R.M.M.K.Namal Rathnayaka
Senior Lecturer
Department of Pharmacology, Faculty of Medicine, Sabaragamuwa University of Sri Lanka, Hidellana, Ratnapura, Sri Lanka.

0714337784

namal@med.sab.ac.lk

Primary study sponsor/organization

George Steuart & Company

No. 45, Janadhipathi Mawatha, Colombo 01, Fort, Colombo 00100, Sri Lanka, Colombo

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Yes

Protocol version and date

2022-11-02 version 2

Protocol URL

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results