NCT05543590

Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID

Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID: PLEXCOVIL Study, a Randomized Controlled Study.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hôpital Européen Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Long-Haul COVID-19

Interventions

Type	Name	Description
DRUG	Plasmapheresis	5 sessions of plasma exchanges
OTHER	Blood collection	Blood collection to assess biological markers at baseline, M3 and M12
OTHER	Stool samples	Stool samples will be collected from participants at baseline,M3 and M12
OTHER	PET scan	PET scan at baseline and M6
OTHER	Cycle ergometer stress test	Cycle ergometer stress test at M6
OTHER	Questionnaires at baseline	Questionnaires at baseline, M3 and M6
OTHER	Medical consultations	Medical consultations

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-02-01
• Completion: 2025-10-01
• First posted: 2022-09-16
• Last updated: 2023-08-14