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

NCT06590207 | Completed Phase 3 DMC

• 1 other identifier: 1381-24-SMC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

WNV; Neutralizing Abs; Convalescent plasma; neuroinvasive

Outcome Measures

Primary Outcomes (1)

• Unfavorable outcom = Composite outcome of mortality or functional deterioration on day 30

  functional deterioration will be defined using Barthel Index

  day 28-32

Secondary Outcomes (5)

• unfavorable outcome on day 90

  day 88-92

• Serious adverse events

  day 2-32

• Mortality

  day 28-92

• Functional deterioration by day 30 & 90

  28-92 days

• Neurologic deterioration by day 30 & 90

  28-92 days

Other Outcomes (2)

• Mechanical ventilation

  2-92 days

• ICU

  2-92days

Study Arms (2)

200ml of neutralizing plasma

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

200 ml Saline

Drug: Saline

Interventions

plasma rich with WNV neutralizing antibodies DRUG

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.

Also known as: Neurtalizing plasma

200ml of neutralizing plasma

Saline DRUG

Placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel, 5265601, Israel

Location

Related Publications (5)

• Bassal R, Shohat T, Kaufman Z, Mannasse B, Shinar E, Amichay D, Barak M, Ben-Dor A, Bar Haim A, Cohen D, Mendelson E, Lustig Y. The seroprevalence of West Nile Virus in Israel: A nationwide cross sectional study. PLoS One. 2017 Jun 16;12(6):e0179774. doi: 10.1371/journal.pone.0179774. eCollection 2017.

  PMID: 28622360 BACKGROUND

• Planitzer CB, Modrof J, Kreil TR. West Nile virus neutralization by US plasma-derived immunoglobulin products. J Infect Dis. 2007 Aug 1;196(3):435-40. doi: 10.1086/519392. Epub 2007 Jun 18.

  PMID: 17597458 BACKGROUND

• Srivastava R, Ramakrishna C, Cantin E. Anti-inflammatory activity of intravenous immunoglobulins protects against West Nile virus encephalitis. J Gen Virol. 2015 Jun;96(Pt 6):1347-1357. doi: 10.1099/vir.0.000079. Epub 2015 Feb 9.

  PMID: 25667322 BACKGROUND

• Gnann JW Jr, Agrawal A, Hart J, Buitrago M, Carson P, Hanfelt-Goade D, Tyler K, Spotkov J, Freifeld A, Moore T, Reyno J, Masur H, Jester P, Dale I, Li Y, Aban I, Lakeman FD, Whitley RJ; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Lack of Efficacy of High-Titered Immunoglobulin in Patients with West Nile Virus Central Nervous System Disease. Emerg Infect Dis. 2019 Nov;25(11):2064-2073. doi: 10.3201/eid2511.190537.

  PMID: 31625835 BACKGROUND

• Mbonde AA, Gritsch D, Harahsheh EY, Kasule SN, Hasan S, Parsons AM, Zhang N, Butterfield R, Shiue H, Norville KA, Reynolds JL, Vikram HR, Chong B, Grill MF. Neuroinvasive West Nile Virus Infection in Immunosuppressed and Immunocompetent Adults. JAMA Netw Open. 2024 Mar 4;7(3):e244294. doi: 10.1001/jamanetworkopen.2024.4294.

  PMID: 38546642 BACKGROUND

Related Links

• Treatment and Prevention of West Nile Virus Disease

MeSH Terms

Conditions

Disease

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michaela Va Smilovici-Ofir, Phd

  Sheba research grants and academic collaboration director

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study will be conducted in a double-blind manner - the preparation/placebo will be provided by the pharmacy in a sealed bag.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infection Prevention & Control Unit, Director

Model Details: double-blind randomized controlled study.

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: September 19, 2024
• Study Start: July 4, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 30, 2025
• Last Updated: April 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)