Administering Convalescent Plasma Rich With Neutralizing Abs. to Hospitalized Adults With WNV - a Double-blind Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Unfavorable outcom = Composite outcome of mortality or functional deterioration on day 30
研究概览
简要总结
Name of the study:
Administering neutralizing convalescent plasma to hospitalized patients with West Nile fever - a double-blind randomized controlled study.
The purpose of this study is to test the safety and effectiveness of giving blood plasma from convalescents rich in neutralizers as treatment against West Nile fever.
详细描述
The study is performed in Sheba Medical Center ( and will be expanded in the soon future to other Medical centers in Israel).
Hospitalized patients diagnosed by blood/CSF PCR or IgM, with West Nile Virus will be recruited to the study.
After signing an informed consent they will be randomized (2:1) to receive either blood plasma rich in neutralizing antibodies or saline as placebo.
Number of participants in this center: 130 Age range: 60 years old and older, 18-60 years old with immunosuppression.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study will be conducted in a double-blind manner - the preparation/placebo will be provided by the pharmacy in a sealed bag.
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
- •Hospitalized patients with positive WNV-PCR with fever/neurological symptoms, and 72 hours have not yet passed since the positive result.
- •Age 60 or older.
- •Age over 18 and younger than 60 with immunosuppression (hypogammaglobulinemia, solid organ transplants, bone marrow transplants, hemato-oncological malignancies).
排除标准
- •Age younger than 60 without immunosuppression.
- •More than 72 hours have passed since the diagnosis of West Nile fever.
- •Pregnant women. Criteria for exclusion from the experiment: none Reference to the inclusion of pregnant women, special populations - children and those lacking judgment- not relevant: excludes pregnant women and special populations
研究组 & 干预措施
200ml of neutralizing plasma
The plasma of the convalescents: produced in the blood bank of Sheba Medical Center, from the blood of Sheba workers who participated in the SPRI study (Helsinki 0196-23) and whose blood was found to have neutralizing antibodies to WNV (above 1:524). The blood units from the volunteers who will donate will meet all the requirements of a normal blood donation and will only include men or women who were not pregnant, and the units will pass all the tests accepted at the blood bank before donation.
干预措施: plasma rich with WNV neutralizing antibodies (Drug)
Saline
200 ml Saline
干预措施: Saline (Drug)
结局指标
主要结局
Unfavorable outcom = Composite outcome of mortality or functional deterioration on day 30
时间窗: day 28-32
functional deterioration will be defined using Barthel Index
次要结局
- unfavorable outcome on day 90(day 88-92)
- Serious adverse events(day 2-32)
- Mortality(day 28-92)
- Functional deterioration by day 30 & 90(28-92 days)
- Neurologic deterioration by day 30 & 90(28-92 days)
研究者
Gili Regev-Yochay MD
Infection Prevention & Control Unit, Director
Sheba Medical Center