The SARS-CoV-2 identified in China in January 2020 is the cause of an unprecedentedpandemic. The SARS-CoV-2 and each viral variant are responsible of a respiratoryinfectious disease, which can be asymptomatic. Nevertheless, a part of infected patientswill experiment serious forms associated with a high mortality rate. Most serious formspresent with lymphopenia and a functional exhaustion of speicifci T lymphocytes. Severalstudies showed that these quantitative and qualitative lymphocyte abnormalities areassociated with unfavourable patients' outcome. The investigators hypothesized that theuse of anti-viral T lymphocytes from convalescent COVID 19 donors could be helpful toimprove the prognosis of COVID-19 serious forms. This study aims to demonstrate thefeasibility of setting up a biobank that could allow the preservation and production of acellular immunotherapy specific to SARS-CoV-2.
Patients who meet the donor selection criteria during their hospitalization for a
COVID-19 infection in the Infectious and Tropical Diseases Department of the University
Hospital of Nancy will be informed of the study.
Recovery generally occurs within 14 days of the date of infection (D0) corresponding to
the date of appearance of the first symptoms of the infection. This is characterized by
the disappearance of patent clinical symptoms such as fever and chills and, for patients
hospitalized for O2 requisition, in the cessation of oxygen therapy.
A medical visit will be scheduled within 28 to 64 days after the beginning of the
SARS-Cov-2 infection (D28 to D64) with the department of hemapheresis of the Nancy
university hospital for the collection of a whole blood bag.
Forty-eight hours before this medical appointment (D26 to D62), the patients included in
the study will be contacted again by phone to ensure that they do not present a
contraindication (fever, appearance of new symptoms since healing and/or feverishness) to
the continuation of the study.
In absence of contraindications, the medical appointment is maintained. During the
medical appointment, the regulatory infectious markers for (i) HIV, (ii) HTLV, (iii)
hepatitis, (iv) syphilis, (v) EBV, (vi) CMV and (vii ) toxoplasmosis will be sought.
The following will also be collected:
(i) a bag of whole blood (450 ml); (ii) 2 x 7 ml dry tubes for serological analyses;
(iii) 3 x 7 ml EDTA tubes for DGV; (iv) 3 tubes of 5 ml on lithium heparin for the
Elispot test and (v) 1 tube of EDTA of 7 ml for HLA typing. The blood bags will be
transported to the Nancy University Hospital Cell Therapy unit (UTCT). The whole blood
samples go into production and undergo a density gradient separation in order to isolate
mononuclear cells before cryopreservation.
Other: 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.
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
CHRU-Nancy - Hopitaux de Brabois - Batiment Philippe Canton
Vandœuvre-lès-Nancy, Lorraine, France
Investigator: Benjamin Lefèvre, M.D.
Contact: +33383157654
b.lefevre@chru-nancy.fr
Benjamin Lefèvre
+33383157654
b.lefevre@chru-nancy.fr
Danièle Bensoussan
d.bensoussan@chru-nancy.fr
Not Provided