Incidence of Severe COVID-19 Infection in Patients With Chronic Lymphocytic Leukemia or Indolent B-cell Non-Hodgkin Lymphoma Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy: an Observational Study by the GIMEMA Working Party on Chronic Lymphoproliferative Disorders and by the Fondazione Italiana Linfomi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 954
- 试验地点
- 15
- 主要终点
- Assess the percentage of patients who develop severe COVID-19 infection
研究概览
简要总结
This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients who received first COVID-19 prophylaxis dose between March 2022 and October 2022.
详细描述
This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients.
All CLL or indolent B-cell NHL patients (follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma) who received first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab according to AIFA indication between March 2022 and October 2022 will be included in the study.
Each patient will be followed for a maximum of 12 months from the first COVID-19 prophylaxis dose.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Patient with CLL or indolent B-NHL who received the first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab as per label indication between March 2022 and October
- •Signed informed consent, if applicable
排除标准
- 未提供
结局指标
主要结局
Assess the percentage of patients who develop severe COVID-19 infection
时间窗: at 12 months
Evaluation of prophylaxis efficacy in terms of percentage of patients with CLL or indolent B-NHL who develop severe COVID-19 infection, defined as COVID-19-related hospitalization or COVID -19 related death
次要结局
未报告次要终点