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Recruiting NCT07295483

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

— Observational Persistent COVID Condition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BioICOPER Long COVID Cohort.
Who it may be relevant to
Registry conditions: Persistent COVID Condition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • 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 me

Primary outcome measures

  • Progression of vascular stiffness measured by carotid-femoral pulse wave velocity (cfPWV) [Time frame: From baseline to 48-month follow-up]
Secondary outcome measures (10)
  • Change in Fatigue Severity Score (FSS) [Time frame: From baseline to 4-year follow-up.]
  • Change in Health-Related Quality of Life (EQ-5D-5L or SF-36) [Time frame: From baseline to 4 years.]
  • Change in Cognitive Function (Montreal Cognitive Assessment, MoCA) [Time frame: Baseline to 4 years]
  • Change in Physical Activity (WHO Physical Activity Questionnaire + 7-day pedometer readings) [Time frame: Baseline to 4 years.]
  • Change in Adherence to the Mediterranean Diet (PREDIMED Questionnaire) [Time frame: Baseline to 4 years.]
  • Change in Body Composition (InBody 230 Bioimpedance Analysis) [Time frame: Baseline to 4 years.]
  • Change in Biomarkers of Endothelial and Inflammatory Activity [Time frame: Baseline to 4 years]
  • Change in Proteomic Profiles [Time frame: 4 years]
  • SARS-CoV-2 Protein Quantification (N and S Proteins) [Time frame: 4 years]
  • AI-Based Predictive Model Performance [Time frame: Baseline to 4 years.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Av. de Portugal 83. Planta 2 — Salamanca

Identifiers

NCT: NCT07295483 · BioICOPER Follow-up Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗