Clinical trial NCT05543590: Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID
Official title: Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID: PLEXCOVIL Study, a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Long-Haul COVID-19
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline
timeFrame: 3 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: Evaluation of the quality of life (SF-36) of patients at month 3 and month 6
timeFrame: 3 months and 6 months
measure: Evaluation of the overall impression of change of patients at month 3 and month 6 (PGIC scale)
timeFrame: 3 months and 6 months
measure: Evolution at month 3 and month 6 of the following clinical signs: post-exertional malaise, dyspnea, headache, myalgia, neuropathic pain, cognitive impairment, anosmia/ageusia, anxiety/depression
timeFrame: 3 months and 6 months
measure: Assessment of patients' functional status at month 3 and month 6 (Post-COVID-19 functional status scale)
timeFrame: 3 months 6 months
measure: Evaluation of the professional or student activity at month 3 and month 6
timeFrame: 3 months and 6 months
measure: Percentage of patients with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline
timeFrame: 6 months
measure: Percentage of patients with improved brain and/or spinal cord metabolism at month 6 compared to baseline
timeFrame: 6 months
measure: Evolution of cytokine profiles and lymphocyte activation markers at month 3 and month 6
timeFrame: 3 months and 6 months
measure: Rate and evolution of autoimmune markers at month 3 and month 6
timeFrame: 3 months and 6 months
measure: Level and evolution of endothelial activity markers at month 3 and month 6
timeFrame: 3 months and 6 months
measure: Evaluation of the microbiotic signature at month 3 and month 6
timeFrame: 3 months and 6 months
Other outcomes:
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