To Analyze the Determining Factors in the Evolution of Subjects Diagnosed With Long COVID at Four Years of Follow-up. BioICOPER Follow-up Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Progression of vascular stiffness measured by carotid-femoral pulse wave velocity (cfPWV)
研究概览
简要总结
Long COVID (persistent COVID) represents a major global health challenge due to its high prevalence (approximately 7%), significant impact on quality of life, and socioeconomic burden. Despite extensive research, diagnostic tools to objectively identify or predict long COVID evolution are still lacking.
The BioICOPER Follow-up Study aims to analyze the influence of biomarker evolution on clinical symptomatology (particularly chronic fatigue) and vascular health after four years of follow-up among 400 participants previously included in the original BioICOPER cohort.
Advanced proteomic analysis, vascular function assessment, and machine-learning-based predictive modeling will be used to identify biomarkers associated with disease progression, stratified by sex. This project will contribute to personalized clinical management of long COVID and improved diagnostic and therapeutic strategies in primary care.
详细描述
The study includes a citizen participation component through the IBSAL Citizen Committee for review and dissemination of results. A prospective observational cohort study following 400 adults with a confirmed diagnosis of long COVID, previously enrolled in the BioICOPER baseline study.
Participants will undergo reevaluation four years after their initial inclusion, assessing:
- Clinical symptoms (fatigue, dyspnea, sleep, cognition, nutrition, frailty).
- Lifestyle factors (physical activity, diet, alcohol and tobacco use).
- Vascular structure and function using carotid ultrasound, pulse wave velocity (SphygmoCor®, Vasera®), and retinal imaging.
- Proteomic profiling and quantification of SARS-CoV-2 N and S proteins using ELISA and mass spectrometry.
- Predictive modeling using artificial intelligence (AI) and bioinformatics methods (ESALAB group).
The study will identify biological, vascular, and behavioral determinants of long COVID progression, aiming to build predictive models to support personalized medicine.
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
- 否
入选标准
- •Adults ≥18 years old.
- •Confirmed previous SARS-CoV-2 infection.
- •Diagnosis of long COVID according to WHO criteria.
- •Participation in the baseline BioICOPER study.
- •Signed informed consent for re-evaluation.
排除标准
- •Acute illness preventing participation.
- •Cognitive or physical impairment limiting data collection.
- •Withdrawal of informed consent.
- •Age < 18 years old
研究组 & 干预措施
BioICOPER Long COVID Cohort
Adults previously enrolled in the BioICOPER study with a clinical diagnosis of long COVID.
干预措施: BioICOPER Long COVID Cohort (Other)
结局指标
主要结局
Progression of vascular stiffness measured by carotid-femoral pulse wave velocity (cfPWV)
时间窗: From baseline to 48-month follow-up
Carotid-femoral pulse wave velocity will be assessed as the gold-standard measure of arterial stiffness, using the SphygmoCor® system. The study will evaluate the longitudinal change in cfPWV between baseline (BioICOPER inclusion) and the 4-year follow-up visit, in order to determine whether long COVID is associated with accelerated vascular aging.
次要结局
- AI-Based Predictive Model Performance(Baseline to 4 years.)
- Change in Fatigue Severity Score (FSS)(From baseline to 4-year follow-up.)
- Change in Health-Related Quality of Life (EQ-5D-5L or SF-36)(From baseline to 4 years.)
- Change in Cognitive Function (Montreal Cognitive Assessment, MoCA)(Baseline to 4 years)
- Change in Physical Activity (WHO Physical Activity Questionnaire + 7-day pedometer readings)(Baseline to 4 years.)
- Change in Adherence to the Mediterranean Diet (PREDIMED Questionnaire)(Baseline to 4 years.)
- Change in Body Composition (InBody 230 Bioimpedance Analysis)(Baseline to 4 years.)
- Change in Biomarkers of Endothelial and Inflammatory Activity(Baseline to 4 years)
- Change in Proteomic Profiles(4 years)
- SARS-CoV-2 Protein Quantification (N and S Proteins)(4 years)