Treatment of West Nile Virus With MGAWN1
Condition: West Nile Neuroinvasive Disease; West Nile Virus Infection; Encephalitis; Meningitis; Acute Flaccid Paralysis; West Nile Fever
MeSH terms: Infections; West Nile Fever; Meningitis; Encephalitis; Paralysis; Fever
Intervention: MGAWN1; Placebo - normal saline
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: West Nile virus; WNV; Encephalitis; Meningitis; Acute Flaccid Paralysis; Monoclonal Antibody; WNND; West Nile Fever; WNF

Summary:

      This study will test a drug called MGAWN1 for the treatment of West Nile infections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent

          2. Be >=18 years of age at the time of enrollment

          3. Have West Nile Fever defined as:

               1. temperature >38°C, headache, AND

               2. positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum
                  or cerebrospinal fluid (CSF)

             OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms
             of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as:

             • West Nile encephalitis (must meet criteria a and b below)

               1. Encephalopathy (depressed or altered level of consciousness, lethargy, or
                  personality change lasting 24 hours)

               2. CSF pleocytosis >=5 cells/mm^3

                  AND/OR

                  • West Nile meningitis (must meet criteria c and d)

               3. Clinical signs of meningeal inflammation, including nuchal rigidity, Kernig or
                  Brudzinski sign, photophobia, or phonophobia

               4. CSF pleocytosis >=5 cells/mm^3

                  AND/OR

                  • Acute flaccid paralysis (must meet criteria e and f)

               5. Acute onset of limb weakness with marked progression over 48 hours

               6. Two or more of the following conditions:

                    -  asymmetry to weakness

                    -  areflexia or hyporeflexia of affected limb(s)

                    -  absence of pain, paresthesia, or numbness in affected limb(s)

                    -  CSF pleocytosis >=5 cells/mm^3

                    -  CSF elevated protein levels (4.5 g/L)

                    -  electrodiagnostic studies consistent with an anterior horn cell process

                    -  or abnormal increased signal in the anterior gray matter as documented by
                       spinal cord magnetic resonance imaging

          4. Have epidemiological factors consistent with West Nile Virus infection (must meet
             criterion a or b below):

               1. Appropriate time of year for West Nile Virus transmission in region

               2. Travel history to a region where West Nile Virus is active

          5. Develop signs and/or symptoms within 14 days before study enrollment.

          6. If female of childbearing potential or male and in a sexual relationship with a female
             of childbearing potential, agree (or have partner agree) to practice abstinence or use
             2 of the following methods of contraception for 120 days (approximately 4 months)
             after study drug administration:

               1. Oral contraceptives, or other form of hormonal birth control including hormonal
                  vaginal rings or transdermal patches

               2. An intrauterine device

               3. Barrier contraception (condom) with a spermicide (i.e., female subject ensures
                  use by male partner[s])

               4. Any other equivalent method of contraception (as judged by the investigator)