Long-Haul COVID-19
Conditions
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.
Interventions
DRUGPlasmapheresis
5 sessions of plasma exchanges
OTHERBlood collection
Blood collection to assess biological markers at baseline, M3 and M12
OTHERStool samples
Stool samples will be collected from participants at baseline,M3 and M12
OTHERPET scan
PET scan at baseline and M6
OTHERCycle ergometer stress test
Cycle ergometer stress test at M6
OTHERQuestionnaires at baseline
Questionnaires at baseline, M3 and M6
OTHERMedical consultations
Medical consultations
Sponsors
Hôpital Européen Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Percentage of patients with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline | 6 months |
Outcome results
None listed