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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: receiving plasmapheresis | Experimental |
| |
| Control group : no treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmapheresis | Drug | 5 sessions of plasma exchanges |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Evaluation of the quality of life (SF-36) of patients at month 3 and month 6 | 3 months and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Blood collection |
| Other |
Blood collection to assess biological markers at baseline, M3 and M12 |
|
| Stool samples | Other | Stool samples will be collected from participants at baseline,M3 and M12 |
|
| PET scan | Other | PET scan at baseline and M6 |
|
| Cycle ergometer stress test | Other | Cycle ergometer stress test at M6 |
|
| Questionnaires at baseline | Other | Questionnaires at baseline, M3 and M6 |
|
| Medical consultations | Other | Medical consultations |
|
| Evaluation of the overall impression of change of patients at month 3 and month 6 (PGIC scale) | 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 |
| 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 |
| 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 |
| Rate and evolution of autoimmune 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 |
| Evaluation of the microbiotic signature at month 3 and month 6 | 3 months and 6 months |
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| D001800 | Blood Specimen Collection |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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