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NCT Number: NCT07094724

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

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.

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Key information

Conditions

West Nile Fever Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

plasma

Biological

administration of IV high-titer WNV-neutralizing plasma

Primary outcomes

  1. All-cause mortality within 30 days post enrollment.

    Time frame: 0-30 days

Secondary outcomes

  1. MMSE score at enrollment and at 30 (±3) days post enrollment

    Time frame: 0-33 days

  2. Discharge to pre-hospitalization residence setting.

    Time frame: 0-90 days.

    Patients who were discharged to their pre-hospitalization residence setting will be coded "1"; Patients who were discharged to another setting (e.g., rehabilitation facility) will be coded "0".

  3. Length of hospital stay

    Time frame: 0-90 days.

  4. Serum WNV PCR, IgG, IgM, IgA and neutralizing antibody levels at enrollment, at 7 (±3) days (if still hospitalized), and 30 (±3) days post enrollment.

    Time frame: 0-33 days

  5. WNV PCR, IgG, IgM, IgA and neutralizing antibodies levels in the CSF, at enrollment and within 48-72 (±48) hours post enrollment.

    Time frame: 0-7 days

  6. Serum will be kept for further assessment of additional immunological indices and markers of inflammation.

    Time frame: 10 years.

  7. Peripheral Blood Mononuclear Cell (PBMC) collection at enrollment, at 14 (±3) days (if still hospitalized), and at 30 (±3) days post enrollment.

    Time frame: 0-33 days

  8. Change in Barthel Index at 30 (±3) days post enrollment, compared to baseline.

    Time frame: 0-33 days.

  9. Change in GCS score at 30 (±3) days post enrollment, compared to enrollment.

    Time frame: 0-33 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Almog Cohen-Huszti

CONTACT

[email protected]

+972545377537

Gili Regev-Yochay, MD

CONTACT

[email protected]

+972526666197

Sponsors and collaborators

Lead sponsor

Gili Regev-Yochay MD

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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