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

NCT05543590 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-14

No results posted yet for this study

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

Interventions

DRUG

Plasmapheresis

5 sessions of plasma exchanges

OTHER

Blood collection

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

OTHER

Stool samples

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

OTHER

PET scan

PET scan at baseline and M6

OTHER

Cycle ergometer stress test

Cycle ergometer stress test at M6

OTHER

Questionnaires at baseline

Questionnaires at baseline, M3 and M6

OTHER

Medical consultations

Medical consultations

Sponsors & Collaborators

  • Hôpital Européen Marseille

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-02-28
Completion
2025-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543590 on ClinicalTrials.gov