NCT07295483

Predictors of Long-Term Evolution in Long COVID; 4-Year Follow-Up. (BioICOPER Follow-up Study)

To Analyze the Determining Factors in the Evolution of Subjects Diagnosed With Long COVID at Four Years of Follow-up. BioICOPER Follow-up Study.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Instituto de Investigación Biomédica de Salamanca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Persistent COVID Condition

Interventions

Type	Name	Description
OTHER	BioICOPER Long COVID Cohort	This observational cohort includes 400 adult participants previously enrolled in the baseline BioICOPER study (2021-2023), who had a confirmed diagnosis of long COVID (persistent COVID-19) according to WHO criteria. Participants will undergo a comprehensive four-year follow-up assessment to evaluate clinical evolution, vascular function, and biological markers of disease persistence and recovery. There is no intervention assigned by the investigators - participants will continue their usual medical care. The study will observe natural disease progression and its association with biomarkers, vascular measurements, and lifestyle factors.

Timeline

• Start date: 2026-02-09
• Primary completion: 2029-03-01
• Completion: 2029-06-01
• First posted: 2025-12-19
• Last updated: 2026-03-12

Locations

1 site across 1 country: Spain