Long-Haul COVID-19PLEXCOVILNCT05543590
Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID
A study testing Plasmapheresis, Blood collection and Stool samples in people with Long-Haul COVID-19, run by Hôpital Européen Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long-Haul COVID-19
- What is being tested?
- Plasmapheresis, Blood collection and Stool samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID: PLEXCOVIL Study, a Randomized Controlled Study.
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.
Read more
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.
- Conditions
- Long-Haul COVID-19
- Being tested
- Plasmapheresis, Blood collection, Stool samples, PET scan, Cycle ergometer stress test
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmapheresisDrug
5 sessions of plasma exchanges
Blood collectionOther
Blood collection to assess biological markers at baseline, M3 and M12
Stool samplesOther
Stool samples will be collected from participants at baseline,M3 and M12
PET scanOther
PET scan at baseline and M6
Cycle ergometer stress testOther
Cycle ergometer stress test at M6
Questionnaires at baselineOther
Questionnaires at baseline, M3 and M6
Medical consultationsOther
Medical consultations
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: receiving plasmapheresis | Experimental | Not described Receives: Drug: Plasmapheresis; Other: Blood collection; Other: Stool samples; Other: PET scan; Other: Cycle ergometer stress test; Other: Questionnaires at baseline |
| Control group : no treatment | Other | Not described Receives: Other: Blood collection; Other: Stool samples; Other: PET scan; Other: Cycle ergometer stress test; Other: Questionnaires at baseline; Other: Medical consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline
Measured: 3 months
Secondary outcomes (12)
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
Measured: 6 months
Evaluation of the quality of life (SF-36) of patients at month 3 and month 6
Measured: 3 months and 6 months
Evaluation of the overall impression of change of patients at month 3 and month 6 (PGIC scale)
Measured: 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
Measured: 3 months and 6 months
Assessment of patients' functional status at month 3 and month 6 (Post-COVID-19 functional status scale)
Measured: 3 months 6 months
Evaluation of the professional or student activity at month 3 and month 6
Measured: 3 months and 6 months
Percentage of patients with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline
Measured: 6 months
Percentage of patients with improved brain and/or spinal cord metabolism at month 6 compared to baseline
Measured: 6 months
Evolution of cytokine profiles and lymphocyte activation markers at month 3 and month 6
Measured: 3 months and 6 months
Rate and evolution of autoimmune markers at month 3 and month 6
Measured: 3 months and 6 months
Level and evolution of endothelial activity markers at month 3 and month 6
Measured: 3 months and 6 months
Evaluation of the microbiotic signature at month 3 and month 6
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study startFeb 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-Haul COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543590
- Sponsor's protocol ID
- 21-
- Acronym
- PLEXCOVIL
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID: PLEXCOVIL Study, a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05543590
- Acronym / sponsor ID
- PLEXCOVIL / 21-
- Conditions
- Long-Haul COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: receiving plasmapheresis | Experimental | Drug: Plasmapheresis, Other: Blood collection, Other: Stool samples, Other: PET scan, Other: Cycle ergometer stress test, Other: Questionnaires at baseline |
| Control group : no treatment | Other | Other: Blood collection, Other: Stool samples, Other: PET scan, Other: Cycle ergometer stress test, Other: Questionnaires at baseline, Other: Medical consultations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmapheresis5 sessions of plasma exchanges | Drug | Experimental group: receiving plasmapheresis |
| Blood collectionBlood collection to assess biological markers at baseline, M3 and M12 | Other | Control group : no treatment, Experimental group: receiving plasmapheresis |
| Stool samplesStool samples will be collected from participants at baseline,M3 and M12 | Other | Control group : no treatment, Experimental group: receiving plasmapheresis |
| PET scanPET scan at baseline and M6 | Other | Control group : no treatment, Experimental group: receiving plasmapheresis |
| Cycle ergometer stress testCycle ergometer stress test at M6 | Other | Control group : no treatment, Experimental group: receiving plasmapheresis |
| Questionnaires at baselineQuestionnaires at baseline, M3 and M6 | Other | Control group : no treatment, Experimental group: receiving plasmapheresis |
| Medical consultationsMedical consultations | Other | Control group : no treatment |
Primary outcome
Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline
Time frame: 3 months
12 secondary outcomes
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
Time frame: 6 months
Evaluation of the quality of life (SF-36) of patients at month 3 and month 6
Time frame: 3 months and 6 months
Evaluation of the overall impression of change of patients at month 3 and month 6 (PGIC scale)
Time frame: 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
Time frame: 3 months and 6 months
Assessment of patients' functional status at month 3 and month 6 (Post-COVID-19 functional status 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 patients with 25% improvement in neuromuscular activity of M wave abnormalities at month 6 compared to baseline
Time frame: 6 months
Percentage of patients 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmapheresis, Blood collection and Stool samples in people with Long-Haul COVID-19, run by Hôpital Européen Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients whose fatigue has decreased by 30% on the Chalder scale at M3 compared to its initial state measured at baseline (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.