Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID
NCT ID: NCT05543590
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-02-28
2025-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group: receiving plasmapheresis
Plasmapheresis
5 sessions of plasma exchanges
Blood collection
Blood collection to assess biological markers at baseline, M3 and M12
Stool samples
Stool samples will be collected from participants at baseline,M3 and M12
PET scan
PET scan at baseline and M6
Cycle ergometer stress test
Cycle ergometer stress test at M6
Questionnaires at baseline
Questionnaires at baseline, M3 and M6
Control group : no treatment
Blood collection
Blood collection to assess biological markers at baseline, M3 and M12
Stool samples
Stool samples will be collected from participants at baseline,M3 and M12
PET scan
PET scan at baseline and M6
Cycle ergometer stress test
Cycle ergometer stress test at M6
Questionnaires at baseline
Questionnaires at baseline, M3 and M6
Medical consultations
Medical consultations
Interventions
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Plasmapheresis
5 sessions of plasma exchanges
Blood collection
Blood collection to assess biological markers at baseline, M3 and M12
Stool samples
Stool samples will be collected from participants at baseline,M3 and M12
PET scan
PET scan at baseline and M6
Cycle ergometer stress test
Cycle ergometer stress test at M6
Questionnaires at baseline
Questionnaires at baseline, M3 and M6
Medical consultations
Medical consultations
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Hôpital Européen Marseille
OTHER
Responsible Party
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Other Identifiers
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21-
Identifier Type: -
Identifier Source: org_study_id
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