IMPACT OF THERAPEUTIC PLASMA EXCHANGE ON ACQUIRED VACCINAL ANTI-SARS-CoV-2 ANTIBODIES.

Overview

Context: Therapeutic plasma exchange (TPE) is an extracorporeal blood purification technique that removes pathogenic substances (including antibodies) from plasma. This technique also combines an immunomodulatory effect. The impact on the anti-SARS-CoV-2 titer and the humoral and cellular response in the general population benefiting from an EFA program is not known at this time. The purpose of this study is to evaluate the evolution of anti-SARS-CoV-2 titer over time in vaccinated adult patients treated with TPE. Research question and associated variables: Prospective non-drug interventional study on the possible variation of anti-SARS-CoV-2 antibody titer in adult patients regularly treated with therapeutic plasma exchange. Study population: any adult patient vaccinated against SARS-CoV-2 (any type of vaccine) and regularly receiving therapeutic plasma exchange in the adult hematology department of the Cliniques universitaires Saint Luc in Brussels, Belgium. Number of subjects expected to be enrolled: 10-15

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2022

Detailed Description

Not provided

Interventions

  • Diagnostic Test: Evolution of antibodies titre
    • For each patient included in this study, 3 blood samples of 5 ml(serum) will be collected at well-defined time points: at the beginning of an TPE session, at the end of the same session, and at the beginning of the consecutive TPE session.

Arms, Groups and Cohorts

  • Other: Evolution of anti-SARS-CoV-2 titer over time in vaccinated adult patients treated with TPE.
    • Assessment of the possible variation of anti-SARS-CoV-2 antibody titer in adult patients regularly treated with therapeutic plasma exchange. For each patient included in this study, 3 blood samples of 5 ml(serum) will be collected at well-defined time points: at the beginning of an TPE session, at the end of the same session, and at the beginning of the consecutive TPE session.

Clinical Trial Outcome Measures

Primary Measures

  • Analysis of the variation of the anti-SARS-CoV-2 antibodies with plasma exchange procedures
    • Time Frame: 3 months
    • Assessement of the evolution of anti-SARS-CoV-2 titer over time in vaccinated adult patients treated with TPE.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients vaccinated against SARS-CoV-2 (any type of vaccine) and regularly receiving therapeutic plasma exchange in the adult hematology department of the Cliniques universitaires Saint Luc. Exclusion Criteria:

  • Patients treated with therapeutic plasma exchange for an acute condition at the intensive care unit – Patients unable to sign the ICF or unwilling to participate to the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cliniques universitaires Saint-Luc- Universit√© Catholique de Louvain
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Catherine Lambert, Pr, Principal Investigator, Cliniques universitaires Saint-Luc
  • Overall Contact(s)
    • Cliniques U Saint-Luc, Pr, +3227641708, catherine.lambert@uclouvain.be

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