COVID-19COVIBankNCT05458440
Bank of Human Leukocytes From COVID-19 Convalescent Donors With an Anti-SARS-CoV-2 Cellular Immunity
A study testing Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donors in people with COVID-19, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Danièle Bensoussan contact
France1 site, 1 recruiting
- Recruiting
CHRU-Nancy - Hopitaux de Brabois - Batiment Philippe Canton
Vandœuvre-lès-Nancy, Lorraine, 54511
Benjamin Lefèvre, M.D., +33383157654, b.lefevre@chru-nancy.fr
Danièle Bensoussan, M.D., PhD, d.bensoussan@chru-nancy.fr
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- COVID-19
- Being tested
- Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donors
- Keywords
- COVID-19, SARS-CoV-2, Cellular Immunotherapy, Viral specific T cells, Bank
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donorsOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (1)
To determine the HLA-type of each leucocyte samples in the bank by DNA-sequencing
The investigators will determine for each patient's biological sample the type of HLA (A, B, DRB1). For this step, a DNA sequencing with new generation sequencing (Illumina MiniSeq) will be used.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Sep 2022
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEFEVRE Benjamin, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458440
- Sponsor's protocol ID
- 2021-A02179-32
- Acronym
- COVIBank
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05458440
- Acronym / sponsor ID
- COVIBank / 2021-A02179-32
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, Cellular Immunotherapy, Viral specific T cells, Bank
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 Convalescent donors | Other | Other: Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donorsThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donorsThe 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. | Other | Covid-19 Convalescent donors |
Primary outcome
To build a biobank of convalescent donors T-lymphocytes samples
Time frame: 12 months
The mononuclear cells of convalescent COVID-19 patients meeting the criteria will be cryopreserved in the bank (feasability study)
1 secondary outcome
To determine the HLA-type of each leucocyte samples in the bank by DNA-sequencing
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danièle Bensoussan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generation of a biobank allowing the cryopreservation of leucocytes from COVID19 convalescent donors in people with COVID-19, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Lefèvre (+33383157654, b.lefevre@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To build a biobank of convalescent donors T-lymphocytes samples (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.