Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID: PLEXCOVIL Study, a Randomized Controlled Study.
| Registry | NCT05543590, acronym PLEXCOVIL |
|---|---|
| Status | Withdrawn - Withdrawn |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Sponsor | Hôpital Européen Marseille (Other) |
| Conditions | Long-Haul COVID-19 |
| Interventions | Plasmapheresis, Blood collection, Stool samples, PET scan, Cycle ergometer stress test, Questionnaires at baseline, Medical consultations (Drug, other) |
| Dates | start 2023-02-01 (estimated), primary completion 2025-02-01 (estimated), completion 2025-10-01 (estimated), first posted 2022-09-16, last updated 2023-08-14 |
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All trials for Long-Haul COVID-19 All trials of Plasmapheresis All trials of Blood collection
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental group: receiving plasmapheresis | Experimental | Drug: Plasmapheresis; Other: Blood collection; Other: Stool samples; Other: PET scan; Other: Cycle ergometer stress test; Other: Questionnaires at baseline | |
| Control group : no treatment | Other | Other: Blood collection; Other: Stool samples; Other: PET scan; Other: Cycle ergometer stress test; Other: Questionnaires at baseline; Other: Medical consultations |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * 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 Exclusion Criteria: * 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