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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- To build a biobank of convalescent donors T-lymphocytes samples
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
To build a biobank of convalescent donors T-lymphocytes samples
时间窗: 12 months
The mononuclear cells of convalescent COVID-19 patients meeting the criteria will be cryopreserved in the bank (feasability study)
次要结局
- To determine the HLA-type of each leucocyte samples in the bank by DNA-sequencing(12 months)
研究者
LEFEVRE Benjamin
Doctor
Central Hospital, Nancy, France