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

April 24, 2025 updated by: Gili Regev-Yochay MD, Sheba Medical Center

Administering Convalescent Plasma Rich With Neutralizing Abs. to Hospitalized Adults With WNV - a Double-blind Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat-Gan, Israel, 5265601
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 200ml of neutralizing plasma
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.
Drug: plasma rich with WNV neutralizing antibodies
200 ml plasma of the convalescents: produced in the blood bank, 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.
Other Names:
  • Neurtalizing plasma
Placebo Comparator: Saline
200 ml Saline
Drug: Saline
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unfavorable outcom = Composite outcome of mortality or functional deterioration on day 30
Time Frame: day 28-32
functional deterioration will be defined using Barthel Index
day 28-32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
unfavorable outcome on day 90
Time Frame: day 88-92
same as primary outcome but on day 90
day 88-92
Serious adverse events
Time Frame: day 2-32
Allergic reaction, pulmonary congestion, hemolysis
day 2-32
Mortality
Time Frame: day 28-92
Mortality by day 90
day 28-92
Functional deterioration by day 30 & 90
Time Frame: 28-92 days
decrease in Barthel index from pre-infection baseline
28-92 days
Neurologic deterioration by day 30 & 90
Time Frame: 28-92 days
combined neurologic score of Barthel index, glasgow outcome score and modified minimental score
28-92 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation
Time Frame: 2-92 days
Mechanical ventilation
2-92 days
ICU
Time Frame: 2-92days
ICU
2-92days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Study Chair: Michaela Va Smilovici-Ofir, Phd, Sheba research grants and academic collaboration director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1381-24-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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