High-Titer Neutralizing Plasma for West Nile Fever in Hospitalized Patients
NCT ID: NCT07094724
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
37 participants
INTERVENTIONAL
2025-07-30
2025-11-30
Brief Summary
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In this study, patients who are sick enough to require hospitalization will receive plasma donated by people who have recovered from West Nile virus and developed high titer neutralizing antibodies against the disease. Researchers will closely monitor these patients to see how quickly their symptoms improve and whether the plasma helps reduce the risk of death or shorten hospital stays.
To evaluate how well the plasma works, researchers will compare these patients to others who were infected in the past for West Nile virus but did not receive plasma. The study will also examine whether the plasma is safe to use and whether it causes any side effects.
Through this research, scientists hope to determine if antibody-rich plasma could become a helpful treatment option for people with severe West Nile virus infections.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WN-neutralizing Plasma
IV plasma
Plasma
administration of IV high-titer WNV-neutralizing plasma
historical untreated control
No interventions assigned to this group
Interventions
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Plasma
administration of IV high-titer WNV-neutralizing plasma
Eligibility Criteria
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Inclusion Criteria
* Symptomatic acute illness, including fever and/or neurological manifestations (headache, somnolence, confusion, seizures, personality changes, extra-pyramidal manifestations, cranial nerve palsies, etc.).
* No more than 72 hours have elapsed since collection of diagnostic sample.
* Age criteria
* Age ≥60 years OR
* Age 18-59 years with previously documented immunosuppression, including hypogammaglobulinemia, treatment with anti-CD20 agents during the last 12 months, hematologic malignancy, bone marrow transplantation, solid organ transplantation, acquired immunodeficiency syndrome (AIDS), or severe primary immunodeficiency.
Exclusion Criteria
* More than 72 hours have elapsed since collection of diagnostic sample.
* Pregnancy.
18 Years
ALL
No
Sponsors
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Gili Regev-Yochay MD
OTHER_GOV
Responsible Party
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Gili Regev-Yochay MD
Director of the Sheba Pandemic Preparedness Research Institute (SPRI)
Principal Investigators
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Gili Regev-Yochay, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Teasdale G, Maas A, Lecky F, Manley G, Stocchetti N, Murray G. The Glasgow Coma Scale at 40 years: standing the test of time. Lancet Neurol. 2014 Aug;13(8):844-54. doi: 10.1016/S1474-4422(14)70120-6.
Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64-7. doi: 10.3109/09638288809164105.
Norris D, Clark MS, Shipley S. The Mental Status Examination. Am Fam Physician. 2016 Oct 15;94(8):635-641.
Katzenellenbogen G, Canetti M, Margalit I, Shusterman Y, Simchovitz-Gesher A, Naveh L, Baharav N, Goldenfeld M, Belkin A, Brod M, Wieder-Finesod A, Leshem E, Magiel E, Levy I, Lustig Y, Indenbaum V, Maggio N, Dekel S, Mechnik B, Peretz Y, Barda N, Tafesh A, Yahav D, Regev-Yochay G. West Nile Virus Outbreak in Israel 2024 Compared with Previous Seasons: A Retrospective Study. Infect Dis Ther. 2025 Jul;14(7):1405-1415. doi: 10.1007/s40121-025-01140-3. Epub 2025 Apr 3.
Popescu CP, Florescu SA, Hasbun R, Harxhi A, Evendar R, Kahraman H, Neuberger A, Codreanu D, Zaharia MF, Tosun S, Ceausu E, Ruta SM, Dragovac G, Pshenichnaya N, Gopatsa G, Shmaylenko O, Nagy E, Malbasa JD, Strbac M, Pandak N, Pullukcu H, Lakatos B, Cag Y, Cascio A, Coledan I, Oncu S, Erdem H. Prediction of unfavorable outcomes in West Nile virus neuroinvasive infection - Result of a multinational ID-IRI study. J Clin Virol. 2020 Jan;122:104213. doi: 10.1016/j.jcv.2019.104213. Epub 2019 Nov 11.
Roberts JA, Kim CY, Hwang SA, Hassan A, Covington E, Heydari K, Lyerly M, Sejvar JJ, Hasbun R, Prasad M, Thakur KT. Clinical, Prognostic, and Longitudinal Functional and Neuropsychological Features of West Nile Virus Neuroinvasive Disease in the United States: A Systematic Review and Meta-Analysis. Ann Neurol. 2025 Jul;98(1):93-106. doi: 10.1002/ana.27220. Epub 2025 Feb 26.
Chancey C, Grinev A, Volkova E, Rios M. The global ecology and epidemiology of West Nile virus. Biomed Res Int. 2015;2015:376230. doi: 10.1155/2015/376230. Epub 2015 Mar 19.
Moirano G, Fletcher C, Semenza JC, Lowe R. Short-term effect of temperature and precipitation on the incidence of West Nile Neuroinvasive Disease in Europe: a multi-country case-crossover analysis. Lancet Reg Health Eur. 2024 Dec 4;48:101149. doi: 10.1016/j.lanepe.2024.101149. eCollection 2025 Jan.
Erazo D, Grant L, Ghisbain G, Marini G, Colon-Gonzalez FJ, Wint W, Rizzoli A, Van Bortel W, Vogels CBF, Grubaugh ND, Mengel M, Frieler K, Thiery W, Dellicour S. Contribution of climate change to the spatial expansion of West Nile virus in Europe. Nat Commun. 2024 Feb 8;15(1):1196. doi: 10.1038/s41467-024-45290-3.
Related Links
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Israel Ministry of Health. West-Nile fever documented cases in Israel, 2000-2024.
Other Identifiers
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SHEBA-25-2255-GR-CTIL
Identifier Type: -
Identifier Source: org_study_id
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