High-Titer Neutralizing Plasma for West Nile Fever in Hospitalized Patients
Recruiting
Phase 2Interventional Study
West Nile Fever
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
37 (estimated)
Sponsor
Gili Regev-Yochay MD · Government
Who this trial is looking for
This trial is looking for adults who are in the hospital due to severe West Nile Fever. Participants will receive plasma from people who have recovered and will be closely monitored to see if it helps them recover faster.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult hospitalized due to West Nile Fever.
I have a positive test for West Nile Fever.
I have symptoms like fever or neurological issues.
I am 60 years or older.
I am 18-59 years old with certain health issues.
You may not be able to join if
I am under 60 years old and do not have significant health issues.
It has been more than 72 hours since my diagnostic sample was taken.
I am currently pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 infecti…
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.
Trial Locations
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City
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Status
Eligibility 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 man…
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.
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