NCT04365322招募中不适用
Étude Des réponses Immunitaires Lymphocytaires spécifiques Chez Des Patients infectés Par le Virus SARS-CoV-2 : Caractéristiques Des Réponses Effectrices et Mémoires
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Specific immune responses
研究概览
简要总结
SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19. The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specific immune responses. COV-CREM is a French prospective monocentric study that will evaluate viral-specific cell responses in positive patients for SARS-CoV-2 on the basis of (RT-PCR) assay performed in respiratory tract sample tested by our local Center for Disease Control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COVID-19 PCR positive,
- •Hospitalized patients with illness of any duration, and/or SpO2 ≤ 92% on room air.
- •Cohorte C : patients with cancer (hematological malignancies and solid tumors).
排除标准
- •Refusal to participate,
- •Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study,
- •Active or chronic hepatitis B or C and/or HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus,
- •Active autoimmune disease that required a systemic treatment, with the following exceptions:
- •Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,
- •Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,
- •Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
- •Patients currently exposed to chemotherapy, anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy or biotherapy (except for patients in cohort C),
- •Previous prescribing of biotherapy or treatment for the management of COVID-19 is not an exclusion criterion,
- •Patient under guardianship, curatorship or under the protection of justice.
结局指标
主要结局
Specific immune responses
时间窗: During COVID-19 infection or one month after COVID-19 infection
Intensity and diversity of immune responses specific for SARS-COV-2
次要结局
未报告次要终点
研究者
研究点 (1)
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