High-titer West Nile Virus-neutralizing Plasma for Hospitalized Patients With West Nile Fever: a Prospective Controlled Clinical Study Using Historical Controls
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- All-cause mortality within 30 days post enrollment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Age <60 years without significant immunosuppression.
- •More than 72 hours have elapsed since collection of diagnostic sample.
- •Pregnancy.
研究组 & 干预措施
WN-neutralizing Plasma
IV plasma
干预措施: Plasma (Biological)
结局指标
主要结局
All-cause mortality within 30 days post enrollment.
时间窗: 0-30 days
次要结局
- MMSE score at enrollment and at 30 (±3) days post enrollment(0-33 days)
- Serum will be kept for further assessment of additional immunological indices and markers of inflammation.(10 years.)
- Change in GCS score at 30 (±3) days post enrollment, compared to enrollment.(0-33 days.)
- Discharge to pre-hospitalization residence setting.(0-90 days.)
- 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)
- 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.)
研究者
Gili Regev-Yochay MD
Director of the Sheba Pandemic Preparedness Research Institute (SPRI)
Sheba Medical Center