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Predictors of Long-Term Evolution in Long COVID; 4-Year Follow-Up. (BioICOPER Follow-up Study)
NCT07295483 · Instituto de Investigación Biomédica de Salamanca
In plain English
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Official title
To Analyze the Determining Factors in the Evolution of Subjects Diagnosed With Long COVID at Four Years of Follow-up. BioICOPER Follow-up Study.
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Acute illness preventing participation.
* Cognitive or physical impairment limiting data collection.
* Withdrawal of informed consent.
* Age \< 18 years old
Study design
Enrollment target: 400 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-02-09
Estimated completion: 2029-06
Last updated: 2026-03-12
Interventions
Other: BioICOPER Long COVID Cohort
Primary outcomes
- • Progression of vascular stiffness measured by carotid-femoral pulse wave velocity (cfPWV) (From baseline to 48-month follow-up)
Sponsor
Instituto de Investigación Biomédica de Salamanca · other
With: Carlos III Health Institute
Contacts & investigators
ContactManuel Angel Gómez Marcos, MD, PhD · contact · magomez@usal.es · +346751143551
InvestigatorManuel Angel Gomez Marcos, MD, PhD · principal_investigator, Centro Asistencial Universitario de Salamanca (CAUSA)
All locations (1)
Av. de Portugal 83. Planta 2Recruiting
Salamanca, Salamanca, Spain