Characterization of the Immunometabolic Signature in Long COVID-19.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Presence of immunometabolic signatures specific of Long COVID in the plasma and mononuclear cells
研究概览
简要总结
The primary objective of this study is to identify immunometabolic signatures associated with Long COVID in plasma and peripheral blood mononuclear cells (PBMC).
详细描述
The mechanisms underlying Long COVID remain poorly understood. Among the symptoms most frequently reported by patients with long COVID, some (fatigue, neurocognitive disorders, muscular weakness) are similar to those reported by patients with innate or acquired abnormalities in energy metabolism, suggesting that metabolic changes could play a role in the disease. On the other hand, other studies have shown that COVID-19 induces an immune dysregulation that could persist after recovery.
The hypothesis of this study is that there are subtle but detectable immunometabolic changes in plasma and PBMC of patients with long COVID. The identification of these specific signatures would help to better understand the physiopathology of this disease and to identify possible therapeutic strategies .
The primary objective of this study is to identify immunometabolic signatures in plasma and peripheral blood mononuclear cells (PBMC) of patients with long COVID, as compared to patients who recovered from COVID-19 without prolonged symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •A/ Inclusion Criteria:
- •For all patients:
- •Age > 18 years
- •Symptomatic COVID-19 diagnosed after 01JAN2021, confirmed by RT-PCR or Antigen test
- •Last SARS-CoV-2 infection diagnosed more than 12 weeks before inclusion
- •Patient covered by the French health insurance
- •Signature of the informed consent
- •For patient with Long COVID :
- •At least one of the following symptoms during the week preceding inclusion: abnormal fatigue, dyspnoea sine materia, abnormal pain (chest, joint, muscle, headache), unusual neurocognitive disorders (concentration disorders, "brain fog", language/memory disorders, paraesthesia)
- •Absence of Return to Usual Health after SARS-CoV-2 infection (patient declaration)
- •Absence of alternative diagnosis for the symptoms
- •For COVID-19 recovered patient (Control) :
- •None of the following symptoms in the 3 week before inclusion: abnormal fatigue, dyspnoea sine materia, abnormal pain (chest, joint, muscle, headache), unusual neurocognitive disorders (concentration disorders, "brain fog", language/memory disorders, paraesthesia)
- •Return to Usual Health after SARS-CoV-2 infection (patient declaration)
排除标准
- •History of severe COVID-19 (Hospitalization)
- •Symptoms caused by sequelae of SARS-CoV-2 infection (in particular, persistence of lung parenchymal abnormalities : pulmonary fibrosis, persistent alveolitis on CT-Scan)
- •Significant Depression or anxiety symptoms, as assessed by a > 10 score on the A or D items of the Hospital anxiety and depression scale (HAD)
- •Presence of one of the following diseases:
- •Inborn errors of metabolism
- •estimated Glomerular filtration rate < 30 ml/min (MDRD)
- •Autoimmune disease
- •Immunosuppressive treatment or immune deficiency
- •Symptomatic heart failure
- •Respiratory failure (COPD stage ≥ 3 or oxygen therapy)
- •Solid cancer or active blood disease
- •Severe malnutrition (albumin < 30 g/L or weight loss ≥10% in 6 months)
- •Obesity with BMI ≥ 35 kg/m²
- •Diabetes not controlled by diet alone
- •Pregnant, breastfeeding or parturient women
- •Deprivation of liberty by judicial or administrative decision
- •Mandatory Psychiatric Care
- •Protected by decision of law
- •Unable to express consent
研究组 & 干预措施
Patients with Long COVID
干预措施: Blood sample (at inclusion and 6 months later) (Biological)
Patients with Long COVID
干预措施: Patient questionnaires (at inclusion and 6 months later) (Other)
COVID-19 recovered patients (Control)
干预措施: Blood sample (at inclusion and 6 months later) (Biological)
COVID-19 recovered patients (Control)
干预措施: Patient questionnaires (at inclusion and 6 months later) (Other)
结局指标
主要结局
Presence of immunometabolic signatures specific of Long COVID in the plasma and mononuclear cells
时间窗: 18 months
Statistical analyzes (multivariate) by Orthogonal Projections to Latent Structures Discriminant Analysis (OPLS-DA) (Q2Ycum \> 0.5, P-value (CV-ANOVA) ≤0.05, Q2Ycum, test permutations \<0) or the median (AUROC test sets) ≥ 0.8 and the median of the p-values associated with the AUROCs of the test sets ≤ 0.05 in the plasma and/or the PBMCs.
Concentration of metabolites and immune mediators in the plasma and mononuclear cells
时间窗: 18 months
Comparison of metabolites and immune mediators in the blood and PBMC of patients with long COVID will be compared with those of control patients using statistical tests after correction of the alpha risk.
次要结局
- Changes in immuno-metabolic signatures 6 months after the initial assessment(18 months)
- Proportion of patients with clinical improvement (return to normal life) at 6 months with correction of the immuno-metabolic signature(18 months)