NCT05458440 Bank of Human Leukocytes From COVID-19 Convalescent Donors With an Anti-SARS-CoV-2 Cellular Immunity
| NCT ID | NCT05458440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Hospital, Nancy, France |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2022-09-01 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05458440 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05458440 currently recruiting?
Yes, NCT05458440 is actively recruiting participants. Contact the research team at b.lefevre@chru-nancy.fr for enrollment information.
Where is the NCT05458440 trial being conducted?
This trial is being conducted at Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT05458440 clinical trial?
NCT05458440 is sponsored by Central Hospital, Nancy, France. The trial plans to enroll 32 participants.
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