West Nile Virus Clinical Trial
Official title:
A Phase I/II Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Intravenous Immunoglobulin G (Omr-IgG-am) Containing High Anti-West Nile Virus Antibody Titers in Patients With, or at High Risk for Progression to West Nile Virus(WNV)
Investigators will assess whether Omr-IgG-am(Trademark), an intravenous immunoglobulin (IVIg)
containing antibodies specific for West Nile virus (WNV), is safe and well-tolerated in
patients with suspected or laboratory diagnosed WNV disease. An initial estimation of
efficacy will also be made.
This Phase I/II study will enroll hospitalized adults with a presumptive diagnosis of West
Nile encephalitis and/or myelitis or those with a positive laboratory test for diagnosis of
WNV infection who are at high risk for progressing to severe neurologic disease based on age
or immunosuppression. Patients will be randomized in blocks of five to receive either
Omr-IgG-am(Trademark), Polygam(Registered Trademark) S/D (IVIG containing minimal anti-WNV
antibodies) or normal saline in a ratio of 3:1:1. Patients and investigators will be blinded
to treatment assignments.
Patients will receive a single intravenous dose of study medication or one of two placebos.
The study participants will receive 0.5 grams/kg of Omr-IgG-am(Trademark) or
Polygam(Registered Trademark) S/D or a comparable volume of normal saline. All patients will
be followed for safety, natural history endpoints, and efficacy. A subset of patients will
have pharmacokinetic measurements of specific anti- WNV antibodies assessed following
treatment.
The primary endpoints are safety and tolerability following Omr-IgG-am(Trademark)
administration.
Secondary endpoints include pharmacokinetics of specific anti-WNV antibodies, mortality in
confirmed WNV positive patients, and the combination of mortality and functional status at
three months in both confirmed WNV-infected patients and all patients by intention to treat.
This combined endpoint will be measured using four standardized measures of cognitive and
functional status: the Barthel Index; the Modified Rankin Scale; the Glasgow Outcome Score;
and the Modified Mini-Mental Status Examination. A comparison of outcomes will be made for
the group receiving Omr-IgG-am(Trademark) versus those receiving either placebo, and between
the two placebo groups. Other secondary endpoints include the proportion of patients in each
group returning to pre-morbid baseline and each subject's improvement at 3 months as compared
to that subject's worst (of any previous) evaluation.
Natural history endpoints will also be assessed. They will include the duration of intensive
care unit (ICU) and hospital stay, development and persistence of WNV-specific IgG and IgM
antibodies, combined functional score and mortality at 3 months between the group with
encephalitis and/or myelitis at baseline versus the group with a positive WNV test only,
outcomes in patients treated late in coma and correlation of outcome with time-to-treatment
following symptom onset.
Investigators will assess whether Omr-IgG-am(Trademark), an intravenous immunoglobulin (IVIg)
containing antibodies specific for West Nile virus (WNV), is safe and well-tolerated in
patients with suspected or laboratory diagnosed WNV disease. An initial estimation of
efficacy will also be made.
This Phase I/II study will enroll hospitalized adults with a presumptive diagnosis of West
Nile encephalitis and/or myelitis or those with a positive laboratory test for diagnosis of
WNV infection who are at high risk for progressing to severe neurologic disease based on age
or immunosuppression. Patients will be randomized in blocks of five to receive either
Omr-IgG-am(Trademark), Polygam(Registered Trademark) S/D (IVIG containing minimal anti-WNV
antibodies) or normal saline in a ratio of 3:1:1. Patients and investigators will be blinded
to treatment assignments.
Patients will receive a single intravenous dose of study medication or one of two placebos.
The study participants will receive 0.5 grams/kg of Omr-IgG-am(Trademark) or
Polygam(Registered Trademark) S/D or a comparable volume of normal saline. All patients will
be followed for safety, natural history endpoints, and efficacy. A subset of patients will
have pharmacokinetic measurements of specific anti- WNV antibodies assessed following
treatment.
The primary endpoints are safety and tolerability following Omr-IgG-am(Trademark)
administration.
Secondary endpoints include pharmacokinetics of specific anti-WNV antibodies, mortality in
confirmed WNV positive patients, and the combination of mortality and functional status at
three months in both confirmed WNV-infected patients and all patients by intention to treat.
This combined endpoint will be measured using four standardized measures of cognitive and
functional status: the Barthel Index; the Modified Rankin Scale; the Glasgow Outcome Score;
and the Modified Mini-Mental Status Examination. A comparison of outcomes will be made for
the group receiving Omr-IgG-am(Trademark) versus those receiving either placebo, and between
the two placebo groups. Other secondary endpoints include the proportion of patients in each
group returning to pre-morbid baseline and each subject's improvement at 3 months as compared
to that subject's worst (of any previous) evaluation.
Natural history endpoints will also be assessed. They will include the duration of intensive
care unit (ICU) and hospital stay, development and persistence of WNV-specific IgG and IgM
antibodies, combined functional score and mortality at 3 months between the group with
encephalitis and/or myelitis at baseline versus the group with a positive WNV test only,
outcomes in patients treated late in coma and correlation of outcome with time-to-treatment
following symptom onset.
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