Predictors of Long-Term Evolution in Long COVID; 4-Year Follow-Up. (BioICOPER Follow-up Study)
NCT ID: NCT07295483
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
400 participants
OBSERVATIONAL
2025-12-31
2029-06-30
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BioICOPER Long COVID Cohort
Adults previously enrolled in the BioICOPER study with a clinical diagnosis of long COVID.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Cognitive or physical impairment limiting data collection.
* Withdrawal of informed consent.
* Age \< 18 years old
18 Years
ALL
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Instituto de Investigación Biomédica de Salamanca
OTHER
Responsible Party
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Principal Investigators
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Manuel Angel Gomez Marcos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centro Asistencial Universitario de Salamanca (CAUSA)
Locations
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Av. de Portugal 83. Planta 2
Salamanca, Salamanca, Spain
Countries
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Central Contacts
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Facility Contacts
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Manuel Angel Gómez Marcos, Md, PhD
Role: primary
Other Identifiers
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BioICOPER Follow-up Study
Identifier Type: -
Identifier Source: org_study_id