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

NCT05191394 | Completed

• 1 other identifier: 2021/08SEP/367
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Therapeutic Plasma Exchange

Keywords

Therapeutic plasma exchange; anti-SARS-CoV-2 antibodies

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

OTHER

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.

Diagnostic Test: Evolution of antibodies titre

Interventions

Evolution of antibodies titre DIAGNOSTIC_TEST

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, International, 1200, Belgium

Location

Study Officials

• Catherine Lambert, Pr

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 13, 2022
• Study Start: September 8, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

BE (1)