Convalescent Plasma for the Treatment of Patients With WNV - a Double- Blind Randomized Controlled Study

The study is performed in Sheba Medical Center ( and will be expanded in the soon future to other Medical centers in Israel).

Hospitalized patients diagnosed by blood/CSF PCR or IgM, with West Nile Virus will be recruited to the study.

After signing an informed consent they will be randomized (2:1) to receive either blood plasma rich in neutralizing antibodies or saline as placebo.

Number of participants in this center: 130 Age range: 60 years old and older, 18-60 years old with immunosuppression.

Inclusion criteria

• Hospitalized patients with positive WNV-PCR with fever/neurological symptoms, and 72 hours have not yet passed since the positive result.
• Age 60 or older.
• Age over 18 and younger than 60 with immunosuppression (hypogammaglobulinemia, solid organ transplants, bone marrow transplants, hemato-oncological malignancies).

Exclusion criteria

• Age younger than 60 without immunosuppression.
• More than 72 hours have passed since the diagnosis of West Nile fever.
• Pregnant women.

Reference to the inclusion of pregnant women, special populations - children and those lacking judgment- not relevant: excludes pregnant women and special populations.

The duration of the medical trial includes the follow-up period after the trial:

The duration of the treatment is one day, single dose of plasma/saline. The follow-up period is 90 days.

The clinical follow-up plan (during and at the end of the treatment):

A total of 10 visits will be conducted. On day 1, the following will be performed: screening, Medical history & Physical examination, IV Convalescent Plasma vs. Saline, Urine and blood for PCR, functional & neurologic assesment, IgG and IgM from serum, blood test for CBC & renal function.

On day 2-7 and 30 and 90, AE will be collected. On day 3, 5, 7 Urine and blood for PCR will be collected. Neurologic assesment will be conducted on all visits. Serology will be collected also on day 30 and 90.

After discharge, a follow-up visit will be performed either by a visit to the clinic or via phone call.

Inclusion criteria

• Hospitalized patients with positive WNV-PCR with fever/neurological symptoms, and 72 hours have not yet passed since the positive result.
• Age 60 or older.
• Age over 18 and younger than 60 with immunosuppression (hypogammaglobulinemia, solid organ transplants, bone marrow transplants, hemato-oncological malignancies).

Exclusion criteria

• Age younger than 60 without immunosuppression.
• More than 72 hours have passed since the diagnosis of West Nile fever.
• Pregnant women. Criteria for exclusion from the experiment: none Reference to the inclusion of pregnant women, special populations - children and those lacking judgment- not relevant: excludes pregnant women and special populations