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

NCT05458440 | Recruiting

• 1 other identifier: 2021-A02179-32
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; Cellular Immunotherapy; Viral specific T cells; Bank

Outcome Measures

Primary Outcomes (1)

• To build a biobank of convalescent donors T-lymphocytes samples

  The mononuclear cells of convalescent COVID-19 patients meeting the criteria will be cryopreserved in the bank (feasability study)

  12 months

Secondary Outcomes (1)

• To determine the HLA-type of each leucocyte samples in the bank by DNA-sequencing

  12 months

Study Arms (1)

Covid-19 Convalescent donors

OTHER

The protocol will be explained during hospitalisation for each donor infected by SARS-CoV-2. 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.

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

Interventions

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

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.

Covid-19 Convalescent donors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU-Nancy - Hopitaux de Brabois - Batiment Philippe Canton

Vandœuvre-lès-Nancy, Lorraine, 54511, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Benjamin Lefèvre

CONTACT

+33383157654; b.lefevre@chru-nancy.fr

Danièle Bensoussan

CONTACT

d.bensoussan@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 14, 2022
• Study Start: September 1, 2022
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)