NCT04932967已完成不适用
Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 14
- 主要终点
- time to SARS-nCov-2 test negativization
研究概览
简要总结
This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.
详细描述
This is a multicenter retrospective, non-interventional observational study. The participating centres will retrospectively review all episodes of SARS-CoV-2 infection occurring in HMs identified at their institutions from February 2020 to May 2021 and treated with nMoAbs, to evaluate their efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •All patients must meet all the following criteria for study entry:
- •Age equal to or greater than 18 years of age.
- •Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
- •Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021
- •Treatment with anti SARS CoV 2 nMoAbs approved by AIFA
- •Not hospitalized for COVID-19 at the time of nMoAbs administration
- •Not on oxygen therapy at the time of nMoAbs administration
- •At least one of the following symptoms for no more than 10 days:
- •Ageusia / dysgeusia
- •Pharyngodynia
- •Tachypnea
- •Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).
排除标准
- •Hematological diseases, other than HM.
- •Not tested positive for SARS-CoV-2
- •Patients in disease remission "off therapy" for more than 6 months
- •Immune plasma treatment in the previous two months
结局指标
主要结局
time to SARS-nCov-2 test negativization
时间窗: 3 months
To assess the efficacy of nMoAbs in infected HM patients compared to the historical control
次要结局
未报告次要终点
研究者
研究点 (14)
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