RecruitingNot ApplicableNCT05458440

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

Human Leucocytes Bank From COVID-19 Cured Patients With a Cellular Immunity Against SARS-CoV-2 :Raw Material for the Preparation of an Anti-SARS-CoV-2 Cellular Immunotherapy

Sponsor

Central Hospital, Nancy, France

Enrollment

32 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

COVID-19

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

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 Criteria13

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

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Interventions

OTHERGeneration 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.