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

Not Applicable

Completed

• Conditions: Therapeutic Plasma Exchange
• Interventions: Diagnostic Test: Evolution of antibodies titre

• Registration Number: NCT05191394
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

Context:

Therapeutic plasma exchange 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 titre and the humoral and cellular responses in the general population benefiting from therapeutic plasma exchanges is not known at this time.

The purpose of this study is to evaluate the evolution of anti-SARS-CoV-2 antibodies' titre over time in vaccinated adult patients treated with therapeutic plasma exchange.

Research question and associated variables:

Prospective non-drug interventional study on the possible variation of anti-SARS-CoV-2 antibody titre 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

Detailed Description

Not provided

Study Timeline

• Study Start: 2021-09-08
• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-13
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evolution of anti-SARS-CoV-2 titer over time in vaccinated adult patients treated with TPE.	Evolution of antibodies titre	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.

Primary Outcome Measures

Name	Time	Method
Analysis of the variation of the anti-SARS-CoV-2 antibodies with plasma exchange procedures	3 months	Evolution of anti-SARS-CoV-2 antibodies titre over time in vaccinated adult patients treated with TPE.

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Bruxelles, International, Belgium