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

Therapeutic Plasma Exchange Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191394
• Other study ID #: 2021/08SEP/367
• Status: Completed
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: November 2022
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Not provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Therapeutic Plasma Exchange

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Bruxelles	International

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the variation of the anti-SARS-CoV-2 antibodies with plasma exchange procedures	Evolution of anti-SARS-CoV-2 antibodies titre over time in vaccinated adult patients treated with TPE.	3 months