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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Therapeutic Plasma Exchange

Treatments: Diagnostic Test: Evolution of antibodies titre

Study type: Interventional

Funder types: Other

Identifiers

NCT05191394

2021/08SEP/367

Details and patient eligibility

About

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

Full description

Not provided

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Evolution of anti-SARS-CoV-2 titer over time in vaccinated adult patients treated with TPE.

Other group

Description:

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.

Treatment:

Diagnostic Test: Evolution of antibodies titre