PLEXCOVIL: Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group: receiving plasmapheresis
|
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: Control group : no treatment
|
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
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline [3 months]
Secondary Outcome Measures
- 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 [6 months]
- Evaluation of the quality of life (SF-36) of patients at month 3 and month 6 [3 months and 6 months]
- Evaluation of the overall impression of change of patients at month 3 and month 6 (PGIC scale) [3 months and 6 months]
- 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 [3 months and 6 months]
- Assessment of patients' functional status at month 3 and month 6 (Post-COVID-19 functional status scale) [3 months 6 months]
- Evaluation of the professional or student activity at month 3 and month 6 [3 months and 6 months]
- Percentage of patients with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline [6 months]
- Percentage of patients with improved brain and/or spinal cord metabolism at month 6 compared to baseline [6 months]
- Evolution of cytokine profiles and lymphocyte activation markers at month 3 and month 6 [3 months and 6 months]
- Rate and evolution of autoimmune markers at month 3 and month 6 [3 months and 6 months]
- Level and evolution of endothelial activity markers at month 3 and month 6 [3 months and 6 months]
- Evaluation of the microbiotic signature at month 3 and month 6 [3 months and 6 months]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Européen Marseille | Marseille | France | 13003 |
Sponsors and Collaborators
- Hôpital Européen Marseille
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-