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

Hôpital Européen Marseille

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Long-Haul COVID-19

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline

Time frame: 3 months

Secondary Outcomes

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

Time frame: 6 months

Evaluation of the quality of life (SF-36) of patients at month 3 and month 6