West Nile FeverPhase 2NCT07094724
High-Titer Neutralizing Plasma for West Nile Fever in Hospitalized Patients
A Phase 2 study testing Plasma in people with West Nile Fever, run by Gili Regev-Yochay MD at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- West Nile Fever
- What is being tested?
- Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jul 2025to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age <60 years without significant immunosuppression.
- More than 72 hours have elapsed since collection of diagnostic sample.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Almog Cohen-Huszti, +972545377537, almog.cohenhuszti@sheba.health.gov.il
About this study
Official title: High-titer West Nile Virus-neutralizing Plasma for Hospitalized Patients With West Nile Fever: a Prospective Controlled Clinical Study Using Historical Controls
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.
Read more
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.
- Conditions
- West Nile Fever
- Being tested
- Plasma
- Keywords
- West Nile Fever, plasma, neuroinvasive WN disease
- Medical subject headings
- West Nile Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaBiological
administration of IV high-titer WNV-neutralizing plasma
| Study group | Role | What they receive |
|---|---|---|
| WN-neutralizing Plasma | Experimental | IV plasma Receives: Biological: Plasma |
| historical untreated control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality within 30 days post enrollment.
Measured: 0-30 days
Secondary outcomes (9)
MMSE score at enrollment and at 30 (±3) days post enrollment
Measured: 0-33 days
Discharge to pre-hospitalization residence setting.
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".
Measured: 0-90 days.
Length of hospital stay
Measured: 0-90 days.
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.
Measured: 0-33 days
WNV PCR, IgG, IgM, IgA and neutralizing antibodies levels in the CSF, at enrollment and within 48-72 (±48) hours post enrollment.
Measured: 0-7 days
Serum will be kept for further assessment of additional immunological indices and markers of inflammation.
Measured: 10 years.
Peripheral Blood Mononuclear Cell (PBMC) collection at enrollment, at 14 (±3) days (if still hospitalized), and at 30 (±3) days post enrollment.
Measured: 0-33 days
Change in Barthel Index at 30 (±3) days post enrollment, compared to baseline.
Measured: 0-33 days.
Change in GCS score at 30 (±3) days post enrollment, compared to enrollment.
Measured: 0-33 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start30 Jul 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for West Nile FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All recruited patients will recieve high neutrlizing plasma, the intervention arm will be compared to historical controls.
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gili Regev-Yochay MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gili Regev-Yochay MD, Sheba Medical Center
- Investigators
- Gili Regev-Yochay, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094724
- Sponsor's protocol ID
- SHEBA-25-2255-GR-CTIL
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified data will be available by a reasonable request to the PI, after publication.
Publications
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Teasdale G, Maas A, Lecky F, Manley G, Stocchetti N, Murray G. The Glasgow Coma Scale at 40 years: standing the test of time. Lancet Neurol. 2014 Aug;13(8):844-54. doi: 10.1016/S1474-4422(14)70120-6.
PubMed 25030516Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64-7. doi: 10.3109/09638288809164105.
PubMed 3042746Norris D, Clark MS, Shipley S. The Mental Status Examination. Am Fam Physician. 2016 Oct 15;94(8):635-641.
PubMed 27929229Katzenellenbogen G, Canetti M, Margalit I, Shusterman Y, Simchovitz-Gesher A, Naveh L, Baharav N, Goldenfeld M, Belkin A, Brod M, Wieder-Finesod A, Leshem E, Magiel E, Levy I, Lustig Y, Indenbaum V, Maggio N, Dekel S, Mechnik B, Peretz Y, Barda N, Tafesh A, Yahav D, Regev-Yochay G. West Nile Virus Outbreak in Israel 2024 Compared with Previous Seasons: A Retrospective Study. Infect Dis Ther. 2025 Jul;14(7):1405-1415. doi: 10.1007/s40121-025-01140-3. Epub 2025 Apr 3.
PubMed 40180788Popescu CP, Florescu SA, Hasbun R, Harxhi A, Evendar R, Kahraman H, Neuberger A, Codreanu D, Zaharia MF, Tosun S, Ceausu E, Ruta SM, Dragovac G, Pshenichnaya N, Gopatsa G, Shmaylenko O, Nagy E, Malbasa JD, Strbac M, Pandak N, Pullukcu H, Lakatos B, Cag Y, Cascio A, Coledan I, Oncu S, Erdem H. Prediction of unfavorable outcomes in West Nile virus neuroinvasive infection - Result of a multinational ID-IRI study. J Clin Virol. 2020 Jan;122:104213. doi: 10.1016/j.jcv.2019.104213. Epub 2019 Nov 11.
PubMed 31778945Roberts JA, Kim CY, Hwang SA, Hassan A, Covington E, Heydari K, Lyerly M, Sejvar JJ, Hasbun R, Prasad M, Thakur KT. Clinical, Prognostic, and Longitudinal Functional and Neuropsychological Features of West Nile Virus Neuroinvasive Disease in the United States: A Systematic Review and Meta-Analysis. Ann Neurol. 2025 Jul;98(1):93-106. doi: 10.1002/ana.27220. Epub 2025 Feb 26.
PubMed 40008684Chancey C, Grinev A, Volkova E, Rios M. The global ecology and epidemiology of West Nile virus. Biomed Res Int. 2015;2015:376230. doi: 10.1155/2015/376230. Epub 2015 Mar 19.
PubMed 25866777Moirano G, Fletcher C, Semenza JC, Lowe R. Short-term effect of temperature and precipitation on the incidence of West Nile Neuroinvasive Disease in Europe: a multi-country case-crossover analysis. Lancet Reg Health Eur. 2024 Dec 4;48:101149. doi: 10.1016/j.lanepe.2024.101149. eCollection 2025 Jan.
PubMed 39717226Erazo D, Grant L, Ghisbain G, Marini G, Colon-Gonzalez FJ, Wint W, Rizzoli A, Van Bortel W, Vogels CBF, Grubaugh ND, Mengel M, Frieler K, Thiery W, Dellicour S. Contribution of climate change to the spatial expansion of West Nile virus in Europe. Nat Commun. 2024 Feb 8;15(1):1196. doi: 10.1038/s41467-024-45290-3.
PubMed 38331945
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-titer West Nile Virus-neutralizing Plasma for Hospitalized Patients With West Nile Fever: a Prospective Controlled Clinical Study Using Historical Controls
- ClinicalTrials.gov ID
- NCT07094724
- Acronym / sponsor ID
- SHEBA-25-2255-GR-CTIL
- Conditions
- West Nile Fever
- Keywords
- West Nile Fever, plasma, neuroinvasive WN disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Gili Regev-Yochay MDOther government
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All recruited patients will recieve high neutrlizing plasma, the intervention arm will be compared to historical controls.
| Arm | Type | Receives |
|---|---|---|
| WN-neutralizing Plasma | Experimental | Biological: PlasmaIV plasma |
| historical untreated control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Age <60 years without significant immunosuppression.
- More than 72 hours have elapsed since collection of diagnostic sample.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmaadministration of IV high-titer WNV-neutralizing plasma | Biological | WN-neutralizing Plasma |
Primary outcome
All-cause mortality within 30 days post enrollment.
Time frame: 0-30 days
9 secondary outcomes
MMSE score at enrollment and at 30 (±3) days post enrollment
Time frame: 0-33 days
Discharge to pre-hospitalization residence setting.
Time frame: 0-90 days.
Length of hospital stay
Time frame: 0-90 days.
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
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
Serum will be kept for further assessment of additional immunological indices and markers of inflammation.
Time frame: 10 years.
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
Change in Barthel Index at 30 (±3) days post enrollment, compared to baseline.
Time frame: 0-33 days.
Change in GCS score at 30 (±3) days post enrollment, compared to enrollment.
Time frame: 0-33 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Background: PubMed 25030516Teasdale G, Maas A, Lecky F, Manley G, Stocchetti N, Murray G. The Glasgow Coma Scale at 40 years: standing the test of time. Lancet Neurol. 2014 Aug;13(8):844-54. doi: 10.1016/S1474-4422(14)70120-6.
- Background: PubMed 3042746Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64-7. doi: 10.3109/09638288809164105.
- Background: PubMed 27929229Norris D, Clark MS, Shipley S. The Mental Status Examination. Am Fam Physician. 2016 Oct 15;94(8):635-641.
- Background: PubMed 40180788Katzenellenbogen G, Canetti M, Margalit I, Shusterman Y, Simchovitz-Gesher A, Naveh L, Baharav N, Goldenfeld M, Belkin A, Brod M, Wieder-Finesod A, Leshem E, Magiel E, Levy I, Lustig Y, Indenbaum V, Maggio N, Dekel S, Mechnik B, Peretz Y, Barda N, Tafesh A, Yahav D, Regev-Yochay G. West Nile Virus Outbreak in Israel 2024 Compared with Previous Seasons: A Retrospective Study. Infect Dis Ther. 2025 Jul;14(7):1405-1415. doi: 10.1007/s40121-025-01140-3. Epub 2025 Apr 3.
- Background: PubMed 31778945Popescu CP, Florescu SA, Hasbun R, Harxhi A, Evendar R, Kahraman H, Neuberger A, Codreanu D, Zaharia MF, Tosun S, Ceausu E, Ruta SM, Dragovac G, Pshenichnaya N, Gopatsa G, Shmaylenko O, Nagy E, Malbasa JD, Strbac M, Pandak N, Pullukcu H, Lakatos B, Cag Y, Cascio A, Coledan I, Oncu S, Erdem H. Prediction of unfavorable outcomes in West Nile virus neuroinvasive infection - Result of a multinational ID-IRI study. J Clin Virol. 2020 Jan;122:104213. doi: 10.1016/j.jcv.2019.104213. Epub 2019 Nov 11.
- Background: PubMed 40008684Roberts JA, Kim CY, Hwang SA, Hassan A, Covington E, Heydari K, Lyerly M, Sejvar JJ, Hasbun R, Prasad M, Thakur KT. Clinical, Prognostic, and Longitudinal Functional and Neuropsychological Features of West Nile Virus Neuroinvasive Disease in the United States: A Systematic Review and Meta-Analysis. Ann Neurol. 2025 Jul;98(1):93-106. doi: 10.1002/ana.27220. Epub 2025 Feb 26.
- Background: PubMed 25866777Chancey C, Grinev A, Volkova E, Rios M. The global ecology and epidemiology of West Nile virus. Biomed Res Int. 2015;2015:376230. doi: 10.1155/2015/376230. Epub 2015 Mar 19.
- Background: PubMed 39717226Moirano G, Fletcher C, Semenza JC, Lowe R. Short-term effect of temperature and precipitation on the incidence of West Nile Neuroinvasive Disease in Europe: a multi-country case-crossover analysis. Lancet Reg Health Eur. 2024 Dec 4;48:101149. doi: 10.1016/j.lanepe.2024.101149. eCollection 2025 Jan.
- Background: PubMed 38331945Erazo D, Grant L, Ghisbain G, Marini G, Colon-Gonzalez FJ, Wint W, Rizzoli A, Van Bortel W, Vogels CBF, Grubaugh ND, Mengel M, Frieler K, Thiery W, Dellicour S. Contribution of climate change to the spatial expansion of West Nile virus in Europe. Nat Commun. 2024 Feb 8;15(1):1196. doi: 10.1038/s41467-024-45290-3.
- Individual participant dataSharing planned: Yes. deidentified data will be available by a reasonable request to the PI, after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gili Regev-Yochay, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plasma in people with West Nile Fever, run by Gili Regev-Yochay MD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gili Regev-Yochay, MD (+972526666197, gili.regev@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality within 30 days post enrollment. (time frame: 0-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07094724, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.