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

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.

Timeline

Start

2024-07-04

Primary completion

2025-01-31

Completion

2025-03-30

Outcome

Missed primary endpoint

paper treatment with WNV-neutralizing plasma did not reduce the composite outcome of death or functional deterioration at 30 days compared to placebo. PMID 41874260 ↗

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• Regev-Yochay G, Barda N, Shusterman Y, Magiel E, Ganmore I, Baharav N, Belkin A, Margalit I, Indenbaum V, Lustig Y, Weiss-Ottolenghi Y, Joseph G, Tomer E, Maggio N, Canetti M, Yonath H, Leshem E, Levy I, Peretz Y, Amit S, Miller L, Misgav M, Landa N, Shinar E, Brod M, Wieder-Finesod A, Harats D, Yahav D. West Nile Virus-Neutralizing Plasma for West Nile Virus Disease. NEJM Evid. 2026 Apr;5(4):EVIDoa2500169. doi: 10.1056/EVIDoa2500169. Epub 2026 Mar 24.

Drugs

Indications