High-antibody plasma treatment for hospitalized West Nile fever patients.
Official title: High-titer West Nile Virus-neutralizing Plasma for Hospitalized Patients With West Nile Fever: a Prospective Controlled Clinical Study Using Historical Controls
Run by Sheba Medical Center · NCT07094724 · Data updated 2026-11-12
This trial will test whether giving plasma rich in West Nile antibodies helps adults hospitalized with severe West Nile fever recover faster and avoid serious complications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 37 (estimated) |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat Gan) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | November 30, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT07094724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults hospitalized with confirmed West Nile fever who are either age ≥60 or age 18–59 with documented immunosuppression, with diagnostic sample collected within 72 hours and not pregnant, are the intended participants.
✕Probably not a fit
Younger adults without significant immunosuppression, people tested more than 72 hours earlier, and pregnant patients are excluded and therefore unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Hospitalized adults with laboratory-confirmed West Nile fever who are either 60 or older or are immunosuppressed and aged 18–59 will receive plasma donated by recovered people with high levels of neutralizing antibodies. Treatment must be given within 72 hours of the diagnostic sample, and investigators will track clinical recovery, complications, length of hospital stay, and survival. Outcomes for treated patients will be compared with patients who do not receive high-titer plasma. The trial uses passive immunotherapy because there are no specific antiviral drugs approved for West Nile virus infection.
Why it matters
Potential benefit: If successful, this treatment could shorten hospital stays and reduce serious complications or deaths from severe West Nile fever.
How similar studies have gone: Passive transfer of convalescent plasma has shown mixed or limited success for other viral infections and clinical data specific to West Nile virus are limited and largely experimental.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Sheba Medical Center
Ramat Gan, Israel Recruiting
Study contacts
- Principal investigator: Gili Regev-Yochay, MD — Sheba Medical Center
- Study coordinator: Gili Regev-Yochay, MD
- Email: gili.regev@sheba.health.gov.il
- Phone: +972526666197
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Community spread of multiple infectious diseases in Cambodia from a One Health perspective
This project will test how common and connected dengue, chikungunya, Zika, Japanese encephalitis, and West Nile infections are among people, animals, and the environment across Cambodia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.