Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID: PLEXCOVIL Study, a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline
研究概览
简要总结
Many patients infected with SARS-Cov-2 present in the months following infection with non-specific symptoms such as non-resolving fatigue, cognitive disorders, dyspnea, headaches, myalgias, sleep disorders, anosmia/ ageusia and post exertion malaise. The persistence of these symptoms is called "post covid syndrome" or "long Covid".
According to the literature, the pathophysiological mechanisms involved in post-covid syndromes would include an inadequate immune response, activation of autoimmunity, persistence of pro-inflammatory biomarkers, endothelial dysfunction and alterations in the intestinal microbiota.
In view of the involved pathophysiological mechanisms, linked to the circulation of pro-inflammatory molecules, autoimmunity or endothelial activation, the role of immuno-modulation in the treatment of long Covid need to be evaluated.
Plasma exchange (PE) by decreasing blood levels of pro-inflammatory cytokines and/or autoimmune markers results in moderate to marked clinical improvement in various types of autoantibody-associated inflammatory, autoimmune and neurological diseases.
The goal of our study is to evaluate the effects of plasmapheresis in patients with moderate to severe long-term COVID compared to patients receiving no treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 years
- •Who have had confirmed SARS-COV2 infection (RT PCR) for at least 6 months
- •Having for more than 6 months at least 3 symptoms among the following: fatigue, post effort malaise, dyspnea, headache, diffuse myalgia/arthromyalgia, neuropathic pain, cognitive disorders, anosmia/ageusia
- •Whose above symptoms have an impact on daily activities
- •And/or on sick leave for more than 3 months
- •And/or having to take to bed for more than 2 hours a day
- •Having given free and informed written consent
- •Being affiliated with or benefiting from social security
排除标准
- •With suspected Covid-19 but not confirmed by RT-PCR test
- •Having a known history of any other pathology that could be confused with the diagnosis of long COVID: multiple sclerosis, autoimmune disease (lupus and Gougerot syndrome, inflammatory muscle disease, and myasthenia gravis), untreated hypothyroidism, major depression, use of narcotics regular.
- •Unable to perform a cycle ergometer stress test
- •With innate or drug-induced coagulation disorders (oral or parenteral anticoagulation)
- •With contraindications to plasmapheresis such as: lack of peripheral venous access or unstable cardiac pathology
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Experimental group: receiving plasmapheresis
干预措施: Plasmapheresis (Drug)
Experimental group: receiving plasmapheresis
干预措施: Blood collection (Other)
Experimental group: receiving plasmapheresis
干预措施: Stool samples (Other)
Experimental group: receiving plasmapheresis
干预措施: PET scan (Other)
Experimental group: receiving plasmapheresis
干预措施: Cycle ergometer stress test (Other)
Experimental group: receiving plasmapheresis
干预措施: Questionnaires at baseline (Other)
Control group : no treatment
干预措施: Blood collection (Other)
Control group : no treatment
干预措施: Stool samples (Other)
Control group : no treatment
干预措施: PET scan (Other)
Control group : no treatment
干预措施: Cycle ergometer stress test (Other)
Control group : no treatment
干预措施: Questionnaires at baseline (Other)
Control group : no treatment
干预措施: Medical consultations (Other)
结局指标
主要结局
Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline
时间窗: 3 months
次要结局
- Evaluation of the microbiotic signature at month 3 and month 6(3 months and 6 months)
- Evaluation of the quality of life (SF-36) of patients at month 3 and month 6(3 months and 6 months)
- Percentage of patients with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline(6 months)
- Percentage of patients with improved brain and/or spinal cord metabolism at month 6 compared to baseline(6 months)
- Evolution of cytokine profiles and lymphocyte activation markers at month 3 and month 6(3 months and 6 months)
- Level and evolution of endothelial activity markers at month 3 and month 6(3 months and 6 months)
- Evolution at month 3 and month 6 of the following clinical signs: post-exertional malaise, dyspnea, headache, myalgia, neuropathic pain, cognitive impairment, anosmia/ageusia, anxiety/depression(3 months and 6 months)
- Rate and evolution of autoimmune markers at month 3 and month 6(3 months and 6 months)
- Assessment of patients' functional status at month 3 and month 6 (Post-COVID-19 functional status scale)(3 months 6 months)
- Evaluation of the professional or student activity at month 3 and month 6(3 months and 6 months)
- Evaluation of the overall impression of change of patients at month 3 and month 6 (PGIC scale)(3 months and 6 months)
- Observation of the evolution of the fatigue (Chalder scale) felt by the patients during the 6 months of the study in the two groups of patients(6 months)