Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID

NCT05543590 | Withdrawn

• 1 other identifier: 21-
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Long-Haul COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

Study Arms (2)

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

Interventions

Plasmapheresis DRUG

5 sessions of plasma exchanges

Experimental group: receiving plasmapheresis

Blood collection OTHER

Blood collection to assess biological markers at baseline, M3 and M12

Control group : no treatment; Experimental group: receiving plasmapheresis

Stool samples OTHER

Stool samples will be collected from participants at baseline,M3 and M12

Control group : no treatment; Experimental group: receiving plasmapheresis

PET scan OTHER

PET scan at baseline and M6

Control group : no treatment; Experimental group: receiving plasmapheresis

Cycle ergometer stress test OTHER

Cycle ergometer stress test at M6

Control group : no treatment; Experimental group: receiving plasmapheresis

Questionnaires at baseline OTHER

Questionnaires at baseline, M3 and M6

Control group : no treatment; Experimental group: receiving plasmapheresis

Medical consultations OTHER

Medical consultations

Control group : no treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Plasmapheresis; Blood Specimen Collection; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: September 16, 2022
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share