Evaluation of Immune Response in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- COVID-19 associated inflammation
研究概览
简要总结
The aim of the project is to evaluate the immunological features of COVID-19 patients. Patients are recruited without any pharmacological treatments restriction. The number of samples is estimated on the basis of feasibility, that means on the maximum number of patients with COVID-19, who are expected to be able to be enrolled by the units involved. Based on the investigators' experience, gained in the onco-immunological field, considering the time and economic resources available, the investigators expect to enroll at least 80 patients.
详细描述
PURPOSES
- Determine the frequency of circulating immune cells (i.e. T cells, B cells, Neutrophils, Monocytes absolute numbers) in COVID-19 patients at Hospital Trust of Verona.
- Determine the plasma levels of soluble factors (i.e. IL-1beta, IL-6, IL-10, TNFalfa) in COVID-19 patients at Hospital Trust of Verona.
- Determinate the immune composition of lung and blood of COVID-19 patients that will be enrolled at Hospital Trust of Verona through single-cell sequencing analysis, capable of detecting also the viral sequences in each leukocyte populations.
- Determine any potential links between cytokine storm, immune cells composition and clinical parameters (i.e.) in COVID-19 patients
- Profile patients with a different stage of disease to identify potential biomarkers
- Identify SARS-CoV-2-associated sequences in immune cells
- To define differences in immune cell composition the immune profiling will be done before and after patients treatment used as part of clinical care in COVID-19 patients.
HYPOTHESES
- Primary: Based on previous reports, COVID-19 patients showed significant immunological alterations that need to be deeply investigated. Therefore, the main objective of this study is to perform a phenotypic characterization of patients with COVID-19
- Secondary: Immunological disorder induced by the infection can generate a systemic pathology. Therefore, a) the investigators will identify potential immune-associated biomarkers for rapid testing; b) the investigators will identify specific viral sequences inside immune cells that can explain the systemic disease c) the investigators will define immunological parameters that correlate with disease progression
JUSTIFICATION
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adults affected by SARS-CoV-
- •These patients can be enrolled also for other clinical studies such as off-label or compassionate treatments.
排除标准
- •Patients that withdraw informed consent
研究组 & 干预措施
Mild disease
COVID-19 hospitalized patients
干预措施: COVID-19 treatment (Drug)
Severe disease
COVID-19 hospitalized patients in intensive care unit
干预措施: COVID-19 treatment (Drug)
paucisymptomatic syndrome
Mild symptomatic patients in home quarantine
干预措施: COVID-19 treatment (Drug)
结局指标
主要结局
COVID-19 associated inflammation
时间窗: 48 hours
Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) \[pg/ml\]
Oxygenation
时间窗: 24 hours
Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)
Diagnostic of COVID disease composite
时间窗: On admission of hospital
SARS-CoV-2 infection will be tested by PCR using nasopharyngeal swab
COVID-19 associated immune disorder
时间窗: 24 hours
Enumeration of circulating cell subsets by flow cytometry \[Cell count/µl\]
次要结局
- Intensive Care Unit Admission(Day 7-14)
- Length of hospital stay(Day 7-14)
- Clinical Status(Day 7-14)
- Changes at the cytokine pattern(14 Days)
- Changes at circulating immune cell composition(14 Days)
- Mortality(Day 7-14)