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

Hôpital Européen Marseille

Status: Withdrawn

Conditions: Long-Haul COVID-19

Treatments: Other: Stool samples; Drug: Plasmapheresis; Other: Medical consultations; Other: Questionnaires at baseline; Other: Cycle ergometer stress test; Other: PET scan; Other: Blood collection

Study type: Interventional

Funder types: Other

Identifiers

NCT05543590

21-

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental group: receiving plasmapheresis

Experimental group

Treatment:

Other: Questionnaires at baseline

Other: PET scan

Drug: Plasmapheresis

Other: Cycle ergometer stress test

Other: Blood collection

Other: Stool samples

Control group : no treatment

Other group

Treatment:

Other: Questionnaires at baseline

Other: PET scan

Other: Medical consultations

Other: Cycle ergometer stress test

Other: Blood collection

Other: Stool samples