Trial Outcomes & Findings for Treatment of West Nile Virus With MGAWN1 (NCT NCT00927953)
NCT ID: NCT00927953
Last Updated: 2022-02-10
Results Overview
The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead
TERMINATED
PHASE2
13 participants
Study Day 2, 7, 14, 28, and 120
2022-02-10
Participant Flow
Participants were recruited over two West Nile virus seasons in 2009 and 2010 at 16 (2009) to 19 (2010) sites in the United States. One participant enrolled in 2009; 12 in 2010.
Participant milestones
| Measure |
MGAWN1
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo - Normal Saline
single intravenous infusion of saline placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
MGAWN1
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo - Normal Saline
single intravenous infusion of saline placebo
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
Baseline Characteristics
Treatment of West Nile Virus With MGAWN1
Baseline characteristics by cohort
| Measure |
MGAWN1
n=6 Participants
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo - Normal Saline
n=7 Participants
single intravenous infusion of saline placebo
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 20.84 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 18.07 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 19.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 2, 7, 14, 28, and 120Population: All randomized participants with confirmed West Nile virus infection
The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead
Outcome measures
| Measure |
MGAWN1
n=4 Participants
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo-Normal Saline
n=5 Participants
single intravenous infusion of saline placebo
|
|---|---|---|
|
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
Day 2
|
0 participants
|
2 participants
|
|
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
Day 7
|
1 participants
|
3 participants
|
|
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
Day 14
|
2 participants
|
3 participants
|
|
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
Day 28
|
2 participants
|
4 participants
|
|
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
Day 120
|
2 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 120 daysPopulation: Intention to treat (ITT)
Includes adverse events considered possibly, probably, or definitely related to study drug
Outcome measures
| Measure |
MGAWN1
n=6 Participants
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo-Normal Saline
n=7 Participants
single intravenous infusion of saline placebo
|
|---|---|---|
|
The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Study Day 2, 7, 14, 28, and 120Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is \<=2. The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead.
Outcome measures
| Measure |
MGAWN1
n=4 Participants
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo-Normal Saline
n=5 Participants
single intravenous infusion of saline placebo
|
|---|---|---|
|
The Number of Participants With a Favorable Neurologic Outcome
Day 2
|
1 participants
|
2 participants
|
|
The Number of Participants With a Favorable Neurologic Outcome
Day 7
|
2 participants
|
2 participants
|
|
The Number of Participants With a Favorable Neurologic Outcome
Day 14
|
2 participants
|
2 participants
|
|
The Number of Participants With a Favorable Neurologic Outcome
Day 28
|
2 participants
|
3 participants
|
|
The Number of Participants With a Favorable Neurologic Outcome
Day 120
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Study Day 0, 2, 7, 14, 28, and 120The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead.
Outcome measures
| Measure |
MGAWN1
n=4 Participants
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo-Normal Saline
n=5 Participants
single intravenous infusion of saline placebo
|
|---|---|---|
|
Mean Modified Rankin Scale Scores
Baseline
|
3.5 units on a scale
Standard Deviation 1.29
|
3.6 units on a scale
Standard Deviation 1.52
|
|
Mean Modified Rankin Scale Scores
Day 2
|
3.5 units on a scale
Standard Deviation 1.29
|
2.8 units on a scale
Standard Deviation 2.22
|
|
Mean Modified Rankin Scale Scores
Day 7
|
3.3 units on a scale
Standard Deviation 1.50
|
2.8 units on a scale
Standard Deviation 1.92
|
|
Mean Modified Rankin Scale Scores
Day 14
|
2.7 units on a scale
Standard Deviation 2.08
|
2.5 units on a scale
Standard Deviation 1.29
|
|
Mean Modified Rankin Scale Scores
Day 28
|
2.8 units on a scale
Standard Deviation 2.75
|
1.3 units on a scale
Standard Deviation 1.26
|
|
Mean Modified Rankin Scale Scores
Day 120
|
3.8 units on a scale
Standard Deviation 2.87
|
2.0 units on a scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Study Day 2, 7, 14, 28, and 120Population: Intention to treat (ITT)
Outcome measures
| Measure |
MGAWN1
n=6 Participants
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo-Normal Saline
n=7 Participants
single intravenous infusion of saline placebo
|
|---|---|---|
|
Time to a >= 1 Point Reduction in the Modified Rankin Scale Score
|
14.0 Days
Interval 7.0 to 127.0
|
15.0 Days
Interval 3.0 to 40.0
|
Adverse Events
MGAWN1
Placebo - Normal Saline
Serious adverse events
| Measure |
MGAWN1
n=6 participants at risk
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo - Normal Saline
n=7 participants at risk
single intravenous infusion of saline placebo
|
|---|---|---|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Completed suicide
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Encephalitis viral
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Meningitis viral
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
MGAWN1
n=6 participants at risk
30 mg/kg single intravenous infusion of MGAWN1
|
Placebo - Normal Saline
n=7 participants at risk
single intravenous infusion of saline placebo
|
|---|---|---|
|
Investigations
Activated PTT prolonged
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6
|
42.9%
3/7 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
|
Nervous system disorders
Ataxia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood bicarbonate increased
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
2/6 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
|
Nervous system disorders
Convulsion
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Drug withdrawal syndrome
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Haematocrit decreased
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
2/6 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
International normalised ratio increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Irritability
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Oedema
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Pharyngitis streptococcal
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Platelet count decreased
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Protein total decreased
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Prothrombin time prolonged
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60