Trial Outcomes & Findings for The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations (NCT NCT00303303)
NCT ID: NCT00303303
Last Updated: 2023-12-01
Results Overview
The range of possible scores is 0 - 100, and a lower score denotes less disability.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
14 days
Results posted on
2023-12-01
Participant Flow
Participant milestones
| Measure |
Fab Antivenom Followed by Fab Antivenom Maintenance
Fab Antivenom followed by Fab antivenom maintenance
|
Fab Antivenom Followed by Placebo Maintenance Therapy
Fab antivenom followed by placebo maintenance therapy
|
Placebo Initial Followed by Placebo Maintenance Therapy
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Fab Antivenom Followed by Fab Antivenom Maintenance
Fab Antivenom followed by Fab antivenom maintenance
|
Fab Antivenom Followed by Placebo Maintenance Therapy
Fab antivenom followed by placebo maintenance therapy
|
Placebo Initial Followed by Placebo Maintenance Therapy
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations
Baseline characteristics by cohort
| Measure |
Experimental: Fab Initial and Maintenance Therapy
n=5 Participants
Active Fab Antivenom initial therapy followed by active Fab antivenom maintenance therapy
|
Experimental: Fab Initial Therapy; Placebo Maintenance
n=4 Participants
Active initial Fab antivenom therapy followed by placebo maintenance therapy.
|
Placebo Comparator: Placebo Initial and Maintenance Therapy
n=4 Participants
Placebo initial and maintenance therapy.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 19.9 • n=5 Participants
|
41 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
39 years
STANDARD_DEVIATION 19 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 16.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 daysThe range of possible scores is 0 - 100, and a lower score denotes less disability.
Outcome measures
| Measure |
Group 1
n=5 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=3 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Limb Function: AMA Disability Rating Score of Envenomated Limb
|
11.2 units on a scale
Standard Deviation 17.20
|
7.75 units on a scale
Standard Deviation 7.18
|
22.67 units on a scale
Standard Deviation 24.70
|
PRIMARY outcome
Timeframe: 14 daysScore ranges from 0-100 with higher scores meaning better function.
Outcome measures
| Measure |
Group 1
n=5 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=3 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Limb Function: AAOS Normative Outcome Study Scoring for Envenomated Limb
|
48.4 score on a scale
Standard Deviation 19.2
|
40.7 score on a scale
Standard Deviation 14.7
|
40.3 score on a scale
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: One yearScore ranges from 0-100 with higher scores meaning better function.
Outcome measures
| Measure |
Group 1
n=5 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=3 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Limb Function: AAOS Normative Outcome Study Scoring for Envenomated Limb
|
55.78 score on a scale
Standard Deviation 2.45
|
55.18 score on a scale
Standard Deviation 2.04
|
54.09 score on a scale
Standard Deviation 3.96
|
PRIMARY outcome
Timeframe: 14 daysScore ranges from 0-100 with higher scores meaning better function. Time in days to return to baseline value.
Outcome measures
| Measure |
Group 1
n=5 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=3 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Limb Function: AAOS--time to Return to Normal Value
|
3.6 days
Standard Deviation 2.8
|
5.5 days
Standard Deviation 1.66
|
6.3 days
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: 14 days0-100 mm visual analog scale. Lower scores mean less pain.
Outcome measures
| Measure |
Group 1
n=5 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=3 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Pain: Visual Analog Score
|
.5 score on a scale
Standard Deviation 1.0
|
6.5 score on a scale
Standard Deviation 7.3
|
19.0 score on a scale
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: First 6 hours from baseline, first 18 hours from baseline, First 24 hours from baseline, 12 monthsPopulation: Collected only for first 24 hours. Month 12 not collected.
Mg of morphine equivalents
Outcome measures
| Measure |
Group 1
n=5 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=3 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Pain Medication Use
First 24 hours from baseline
|
5.2 miligrams
Standard Deviation 6.6
|
43.5 miligrams
Standard Deviation 40.5
|
29.9 miligrams
Standard Deviation 15.6
|
|
Pain Medication Use
First 6 hours from baseline
|
4.4 miligrams
Standard Deviation 4.45
|
15.95 miligrams
Standard Deviation 9.32
|
13.1 miligrams
Standard Deviation 2.45
|
|
Pain Medication Use
first 18 hours from baseline
|
.8 miligrams
Standard Deviation 1.6
|
27.5 miligrams
Standard Deviation 28.9
|
16.8 miligrams
Standard Deviation 13.38
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysOutcome measures
| Measure |
Group 1
n=5 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=3 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Swelling: % Change in Volume Compared to Contralateral (Non-envenomated) Limb
|
1 percentage of change
Standard Deviation 5
|
2 percentage of change
Standard Deviation 6
|
-8 percentage of change
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Week 4Population: At week 4: data not collected from 3 participants in Fab Antivenom followed by Fab antivenom maintenance arm; data not collected from 3 participants in the Fab antivenom followed by placebo maintenance therapy arm; no data collected in the Placebo initial followed by placebo maintenance therapy arm. Data not collected at month 12 for any participants
Outcome measures
| Measure |
Group 1
n=2 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=1 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Limb Function: Return to Work
|
3.75 days
Standard Deviation .25
|
4 days
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: At week 4: data not collected from 3 participants in Fab Antivenom followed by Fab antivenom maintenance arm; data not collected from 3 participants in the Fab antivenom followed by placebo maintenance therapy arm; data only collected from 1 in the Placebo initial followed by placebo maintenance therapy arm. Data not collected at month 12 for any participants
Outcome measures
| Measure |
Group 1
n=2 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=1 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=1 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Limb Function: Physical or Occupational Therapy Sessions Attended
|
0 number of sessions
|
0 number of sessions
|
0 number of sessions
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not collected at month 12
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsNumber of participants with acute hypersensitivity reactions
Outcome measures
| Measure |
Group 1
n=5 Participants
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 Participants
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=3 Participants
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
Complications of Therapy
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=5 participants at risk
Fab Antivenom followed by Fab antivenom maintenance
|
Group 2
n=4 participants at risk
Fab antivenom followed by placebo maintenance therapy
|
Group 3
n=4 participants at risk
Placebo initial and maintenance therapy
|
|---|---|---|---|
|
General disorders
Acute hypersensitivity reaction
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Cardiac disorders
Hypotension
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Cardiac disorders
Tachycardia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
Additional Information
William Kerns II MD Program Directorm Medical Toxicology
Carolinas Medical Center
Phone: 704-355-5297
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place