This study will test a drug called MGAWN1 for the treatment of West Nile infections.
The objective of this study is to evaluate the safety, efficacy, and pharmacokinetics of MGAWN1 in subjects with West Nile Fever or a syndrome compatible with West Nile Neuroinvasive Disease (WNND) \[encephalitis, meningitis, or acute flaccid paralysis\]. Subjects can be enrolled based on a syndrome compatible with WNND, and do not need documented West Nile virus infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Humanized monoclonal to West Nile virus. Dose = 30 mg/kg actual body weight intravenous, one dose at Day 0.
Normal Saline intravenous, volume same as active comparator, one dose at Day 0
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
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
Time frame: Study Day 2, 7, 14, 28, and 120
The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event
Includes adverse events considered possibly, probably, or definitely related to study drug
Time frame: 120 days
The Number of Participants With a Favorable Neurologic Outcome
Favorable 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.
Time frame: Study Day 2, 7, 14, 28, and 120
Mean Modified Rankin Scale Scores
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.
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Time frame: Study Day 0, 2, 7, 14, 28, and 120
Time to a >= 1 Point Reduction in the Modified Rankin Scale Score
Time frame: Study Day 2, 7, 14, 28, and 120