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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
administration of IV high-titer WNV-neutralizing plasma
Sheba Medical Center
Ramat Gan, Israel
RECRUITINGAll-cause mortality within 30 days post enrollment.
Time frame: 0-30 days
MMSE score at enrollment and at 30 (±3) days post enrollment
Time frame: 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".
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.
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