RecruitingPhase 2NCT07094724

High-Titer Neutralizing Plasma for West Nile Fever in Hospitalized Patients

High-titer West Nile Virus-neutralizing Plasma for Hospitalized Patients With West Nile Fever: a Prospective Controlled Clinical Study Using Historical Controls


Sponsor

Gili Regev-Yochay MD

Enrollment

37 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will test whether plasma containing high levels of neturalizing antibodies against West Nile virus (WNV) can help people hospitalized with severe West Nile fever recover faster and avoid serious complications. West Nile virus is spread by mosquitoes and can cause mild flu-like symptoms or, in severe cases, brain infections. Currently, there is no specific medication to treat the infection, and doctors primarily provide supportive care. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Adults hospitalized due to WNF, confirmed by a positive IgM or PCR result in blood or cerebrospinal fluid (CSF).
  • 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 Criteria3

  • Age <60 years without significant immunosuppression.
  • More than 72 hours have elapsed since collection of diagnostic sample.
  • Pregnancy.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPlasma

administration of IV high-titer WNV-neutralizing plasma


Locations(1)

Sheba Medical Center

Ramat Gan, Israel

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07094724