Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-… (NCT05543590) | Clinical Trial Compass
WithdrawnNot Applicable
Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID
Stopped: Withdrawn
0Started 2023-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline