Covid-19 Convalescent Plasma Used for Treatment of Patients in Norway - a Monitoring Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- observation
研究概览
简要总结
NORPLASMA COVID-19 includes both the production of convalescent plasma from approved blood donors who have recovered from covid-19 (coronavirus disease 2019), and clinical studies to evaluate efficacy and safety of the treatment, as recommended by European health authorities. Patients who receive convalescent plasma in a clinical setting will be invited to participate in the monitoring study NORPLASMA MONITOR, where clinical data about safety and effect on clinical parameters including virus load and recovery time will be collected and compared to european patients in a common database for the European countries. The treated patients can be compared to a historical control group.
详细描述
The NORPLASMA MONITOR study:
Main hypothesis: Plasma from selected COVID-19 convalescent blood donors contain neutralizing/therapeutic antibodies against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that may prevent generalized spreading of the infection if administered in a sufficient dose at the right time.
The aim of the monitoring study is to monitor the treatment, characterize antibody properties, dose requirements and safety issues.
In the NORPLASMA MONITOR study, the investigators will collect data from all patients treated with convalescent plasma in Norwegian hospitals/care institutions. The data will be compared to historical controls to evaluate efficacy, and for all transfusions, antibody characteristics and effective doses can be retrospectively calculated.
The complete protocol is available on our web site https://www.ous-research.no/home/norplasma.
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
- •patients treated with covid-19 convalescent plasma
- •patients who has provided informed consent or where nearest relative has given consent
排除标准
- •patients included in other clinical studies of covid-19 treatment
- •consent not given
- •All eligible patients should be invited.
结局指标
主要结局
observation
时间窗: up to 2 years
clinical data and lab results from patients who receive COVID-19 convalescent plasma on a clinical indication, are being collected for later analysis
次要结局
未报告次要终点
研究者
Lise Sofie Haug Nissen-Meyer
Project manager
Oslo University Hospital