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

NCT07295483 | Recruiting

• 1 other identifier: BioICOPER Follow-up Study
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent COVID Condition

Keywords

Post-acute COVID syndrome; Vascular aging; Proteomics; Biomarkers; Machine learning; Persistent COVID; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Progression of vascular stiffness measured by carotid-femoral pulse wave velocity (cfPWV)

  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.

  From baseline to 48-month follow-up

Secondary Outcomes (10)

• 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.

Study Arms (1)

BioICOPER Long COVID Cohort

Adults previously enrolled in the BioICOPER study with a clinical diagnosis of long COVID.

Other: BioICOPER Long COVID Cohort

Interventions

BioICOPER Long COVID Cohort OTHER

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.

BioICOPER Long COVID Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults previously enrolled in the BioICOPER study with a clinical diagnosis of long COVID.

You may qualify if:

• 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.

You may not qualify if:

• Acute illness preventing participation.
• Cognitive or physical impairment limiting data collection.
• Withdrawal of informed consent.
• Age \< 18 years old

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Av. de Portugal 83. Planta 2

Salamanca, Salamanca, 37005, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma samples for proteomic and biomarker analysis.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Angel Gomez Marcos, MD, PhD

  Centro Asistencial Universitario de Salamanca (CAUSA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Angel Gómez Marcos, MD, PhD

CONTACT

+346751143551; magomez@usal.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 19, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available starting 12 months after publication of primary results and for a minimum of 5 years thereafter.
• Access Criteria: Sharing Access Criteria: Qualified researchers with a methodologically sound proposal, as determined by the study steering committee, will be able to access the data. Requests should be directed to the study PI. A data access agreement will be required.

Locations

ES (1)