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

Sheba Medical Center

Status and phase: Completed; Phase 3

Conditions: West Nile Fever With Neurologic Manifestation (Diagnosis); West Nile Fever Without Complications

Treatments: Drug: plasma rich with WNV neutralizing antibodies; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06590207

1381-24-SMC

Details and patient eligibility

About

Name of the study:

Administering neutralizing convalescent plasma to hospitalized patients with West Nile fever - a double-blind randomized controlled study.

The purpose of this study is to test the safety and effectiveness of giving blood plasma from convalescents rich in neutralizers as treatment against West Nile fever.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

200ml of neutralizing plasma

Experimental group

Description:

The plasma of the convalescents: produced in the blood bank of Sheba Medical Center, from the blood of Sheba workers who participated in the SPRI study (Helsinki 0196-23) and whose blood was found to have neutralizing antibodies to WNV (above 1:524). The blood units from the volunteers who will donate will meet all the requirements of a normal blood donation and will only include men or women who were not pregnant, and the units will pass all the tests accepted at the blood bank before donation.

Treatment:

Drug: plasma rich with WNV neutralizing antibodies

Saline

Placebo Comparator group

Description:

200 ml Saline

Treatment:

Drug: Saline