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Recruiting Not applicable

Bank of Human Leukocytes From COVID-19 Convalescent Donors With an Anti-SARS-CoV-2 Cellular Immunity

NCT05458440 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-09-01
Last updated
2025-08-08

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donors

Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donors: The investigators aim to demonstrate that it is possible to implement a biobank of leucocytes from convalescent donors that could be used as raw material to generate anti-SARS COV-2 viral specific T cells. The protocol will be explained during hospitalisation for each donor. If they agree, they will be included before they leave hospital. Few weeks later, if they have no exclusion criteria, they will consult in the hemapheresis department of the Nancy University hospital. After medical exams, a whole blood bag and blood samples will be taken with the aim to establish a bank of cryopreserved human leucocytes as a raw material for the generation of a T-Lymphocyte immunotherapy.

Study summary

The SARS-CoV-2 identified in China in January 2020 is the cause of an unprecedented pandemic. The SARS-CoV-2 and each viral variant are responsible of a respiratory infectious disease, which can be asymptomatic. Nevertheless, a part of infected patients will experiment serious forms associated with a high mortality rate. Most serious forms present with lymphopenia and a functional exhaustion of speicifci T lymphocytes. Several studies showed that these quantitative and qualitative lymphocyte abnormalities are associated with unfavourable patients' outcome. The investigators hypothesized that the use of anti-viral T lymphocytes from convalescent COVID 19 donors could be helpful to improve the prognosis of COVID-19 serious forms. This study aims to demonstrate the feasibility of setting up a biobank that could allow the preservation and production of a cellular immunotherapy specific to SARS-CoV-2.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patient hospitalised for proved SARS-CoV-2 infection in the infectious disease unit of the Nancy University Hospital who received a comprehensive information about the study, and accepted to participate * Patient who has an active cellular immunity against SARS-CoV-2 (biological definition: Elispot IFNgamma : \> 50 SFC/106 PBMC) Exclusion Criteria: * Patient hospitalised in Intensive car unit * Patient with haemoglobin \< 10 g/dl * Patient who take hypertension medication * Patient with cardiovascular history: Valvulopathy, conduction rythm disorders, arterial vascular insufficiency, congenital anomalies * Patient with auto-immune disease * Patient with medical history of solid or hematopoietic graft * Patient with active malignant disease (haematological or neoplasm) or considered in remission since less than 2 years * Patient with psychiatric disorders * Patient subject to a legal protection measure. * Patient with proved infectious disease * Asplenic patient * Pregnant or breastfeeding woman * Woman without contraception

Primary outcome measure(s)

  • To build a biobank of convalescent donors T-lymphocytes samples — 12 months
    The mononuclear cells of convalescent COVID-19 patients meeting the criteria will be cryopreserved in the bank (feasability study)

Trial sites (1)

FacilityCityRegionStatus
CHRU-Nancy - Hopitaux de Brabois - Batiment Philippe Canton Vandœuvre-lès-Nancy Lorraine Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05458440 on ClinicalTrials.gov ↗ ← All trials in France