| Methods |
Study title: Effect of plasmapheresis on clinical improvement and biological parameters of patients with long‐haul COVID: PLEXCOVIL Study, a Randomized Controlled Study
Study design: open‐label, parallel‐assignment RCT
Study type: interventional
Country: France
Number of centres: 1
Estimated participants: 60
Date posted: 16 September 2022
Last update: 16 September 2022
Estimated completion: October 2025 |
| Participants |
Inclusion criteria:
Aged ≥ 18 years Who have had confirmed SARS‐CoV‐2 infection RT‐PCR for at least 6 months Having at least 3 of the following symptoms for more than 6 months: fatigue, posteffort malaise, dyspnoea, 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 benefitting 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
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| Interventions |
Intervention arm: plasmapheresis involving 5 sessions of plasma exchange
Control arm: no treatment |
| Outcomes |
Primary outcome:
Secondary outcomes:
Observation of the evolution of the fatigue (Chalder scale) felt by the participants during the 6 months of the study in the 2 groups of participants [Time Frame: 6 months] Evaluation of the quality of life (via SF‐36) of participants at month 3 and month 6 [Time Frame: 3 months and 6 months] Evaluation of the overall impression of change of participants at month 3 and month 6 (via PGIC scale) [Time Frame: 3 months and 6 months] Evolution at month 3 and month 6 of the following clinical signs: postexertional malaise, dyspnoea, headache, myalgia, neuropathic pain, cognitive impairment, anosmia/ageusia, anxiety/depression [Time Frame: 3 months and 6 months] Assessment of participants' functional status at month 3 and month 6 (PCFS scale) [Time Frame: 3 months 6 months] Evaluation of the professional or student activity at month 3 and month 6 [Time Frame: 3 months and 6 months] Percentage of participants with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline [Time Frame: 6 months] Percentage of participants with improved brain and/or spinal cord metabolism at month 6 compared to baseline [Time Frame: 6 months] Evolution of cytokine profiles and lymphocyte activation markers at month 3 and month 6 [Time Frame: 3 months and 6 months] Rate and evolution of autoimmune markers at month 3 and month 6 [Time Frame: 3 months and 6 months] Level and evolution of endothelial activity markers at month 3 and month 6 [Time Frame: 3 months and 6 months] Evaluation of the microbiotic signature at month 3 and month 6 [Time Frame: 3 months and 6 months]
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| Notes |
Sponsor: Hôpital Européen Marseille
Current status: not yet recruiting |
