Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Chalder Fatigue Scale
研究概览
简要总结
The complex clinical symptoms of post COVID syndrome, especially chronic fatigue, pose a major challenge to patients and to the health care system and are frequently refractory to therapeutic intervention. There is increasing evidence that a dysregulated post-viral immune response may be involved in the pathogenesis of post COVID syndrome. In uncontrolled case studies, an improvement of fatigue symptoms after removing autoantibodies has been reported in post COVID patients. However, there is a lack of prospective, sham controlled studies. We initiate an interventional, randomised, sham treatment-controlled prospective study, the EXTINCT post COVID study, which aims to scientifically test the therapeutic efficacy of an extracorporeal apheresis procedure (immunoadsorption) for the treatment of a well characterized cohort of patients with post COVID syndrome, while at the same time providing basic research evidence for an understanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtain important insights into the diagnosis, treatment and pathophysiology of post-COVID syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Chronic Fatigue Syndrome (CFS) according to Canadian Consensus Criteria (at two time points > 4 weeks apart) with a duration of > 6 months with new onset < 12 weeks after PCR test confirmed SARS-CoV2-infection
- •Chalder Fatigue Scale >/= 4 binary scale (at two time points > 4 weeks apart)
- •Post exertional malaise >/= 14 h (at two time points > 4 weeks apart)
- •Bell Scale 20-50 (at two time points > 4 weeks apart)
- •Willing to comply with all aspects of the protocol, including blood draws, magnetic resonance imaging and ophthalmological evaluation
- •Patient is able to understand and fully participate in the activities of the study and consent in accordance with guidelines
- •Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire period.
- •Exclusion citeria:
- •Chronic fatigue due to other medical or psychological condition
- •Preexisting chronic fatigue prior to COVID infection
- •Oxygen requirement or ventilation during acute phase of COVID
- •Positive SARS-CoV-2-PCR test at the beginning of the study
- •Comorbidity bearing risk that patient might not tolerate treatment as judged by investigator including among others: malignant disease within the last 5 years, moderate to severe renal impairment (eGFR <60 ml/min), cardiac insufficiency (LVEF <40%), severe coronary heart disease, severe hypercoagulability
- •Acute or severe psychiatric disease
- •Active/acute infectious diseases like CMV, EBV, HBV, HCV, HIV, TBC
- •Patients who in the investigator's opinion might not be suitable for study (difficult peripheral venous access, not able to complete questionnaires e.g. due to language problems)
- •Taking immunosuppressive medication >3 weeks within 12 months before study inclusion
- •Any apheresis therapy before study inclusion
- •Contraindications for magnetic resonance imaging
- •Patients revealing abnormal brain structures visible in MR images
- •Patients with pre-existing ophthalmological condition or diabetes mellitus
排除标准
- 未提供
研究组 & 干预措施
Immunoadsorption
5 immunoadsorption treatments
干预措施: Immunoadsorption vs. sham immunoadsorption (Procedure)
Sham immunoadsorption
5 sham immunoadsorption treatments
干预措施: Immunoadsorption vs. sham immunoadsorption (Procedure)
结局指标
主要结局
Chalder Fatigue Scale
时间窗: 12 weeks
Time course of fatigue symptoms as determined based on Chalder Fatigue Scale (ranging from 0 to 33), higher values indicating a higher burden of fatigue symptoms
次要结局
- Measure of health status(12 weeks)
- Hand grip strength(12 weeks)
- Cognitive Function(12 weeks)
- Optical coherence tomography angiography(12 weeks)
- Post exertional malaise symptoms(12 weeks)
- Cranial magnetic resonance imaging and spectroscopy(12 weeks)
- Symptoms related to chronic fatigue before and after immunoadsorption(12 weeks)
- Depression and Anxiety(12 weeks)
- Autonomic dysfunction(12 weeks)
- 6-min. walk test(12 weeks)
- Neurocognitive function(12 weeks)