West Nile Fever
Conditions
Keywords
West Nile Fever, plasma, neuroinvasive WN disease
Brief 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.
Interventions
BIOLOGICALPlasma
administration of IV high-titer WNV-neutralizing plasma
Sponsors
Gili Regev-Yochay MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All recruited patients will recieve high neutrlizing plasma, the intervention arm will be compared to historical controls.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality within 30 days post enrollment. | 0-30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discharge to pre-hospitalization residence setting. | 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. |
| Length of hospital stay | 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. | 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. | 0-7 days | — |
| MMSE score at enrollment and at 30 (±3) days post enrollment | 0-33 days | — |
| Peripheral Blood Mononuclear Cell (PBMC) collection at enrollment, at 14 (±3) days (if still hospitalized), and at 30 (±3) days post enrollment. | 0-33 days | — |
| Change in Barthel Index at 30 (±3) days post enrollment, compared to baseline. | 0-33 days. | — |
| Change in GCS score at 30 (±3) days post enrollment, compared to enrollment. | 0-33 days. | — |
| Serum will be kept for further assessment of additional immunological indices and markers of inflammation. | 10 years. | — |
Countries
Israel
Contacts
Primary ContactGili Regev-Yochay, MD
Backup ContactAlmog Cohen-Huszti
Outcome results
None listed