Four-year follow-up to find predictors of long COVID progression
To Analyze the Determining Factors in the Evolution of Subjects Diagnosed With Long COVID at Four Years of Follow-up. BioICOPER Follow-up Study.
This follow-up will try to see if changes in blood proteins and blood vessel tests can predict how long COVID symptoms, especially persistent fatigue, change over four years in people who had long COVID.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Biomédica de Salamanca Academic / other |
| Locations | 1 site (Salamanca, Salamanca) |
| Trial ID | NCT07295483 on ClinicalTrials.gov |
What this trial studies
The BioICOPER follow-up is a prospective observational cohort of 400 adults with confirmed long COVID who previously joined the baseline BioICOPER cohort and will be re-evaluated four years later. Participants will have detailed clinical symptom inventories, lifestyle questionnaires, vascular imaging (carotid ultrasound, pulse wave velocity, retinal imaging), and advanced proteomic blood analyses including SARS‑CoV‑2 protein quantification. Results from these biological and vascular measures will be integrated with machine-learning models to identify biomarkers and build predictive signatures, with analyses stratified by sex. The project includes citizen engagement through a local committee for review and dissemination of findings to patients and primary care providers.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with a prior confirmed SARS‑CoV‑2 infection who meet WHO criteria for long COVID and who participated in the original BioICOPER baseline study and can give informed consent for re-evaluation.
Not a fit: People who cannot attend in-person assessments, who have acute illnesses preventing participation, or whose limitations prevent data collection (severe cognitive or physical impairment) may not benefit from participation.
Why it matters
Potential benefit: If successful, the study could enable earlier identification of people at risk of worsening long COVID and support more personalized diagnostic and management decisions based on biological and vascular markers.
How similar studies have performed: Smaller proteomic and vascular studies have suggested biological signatures linked to post‑acute COVID symptoms, but large multi-year follow-ups combining proteomics, vascular imaging, and AI-based prediction remain relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salamanca, Salamanca
- Av. de Portugal 83. Planta 2 — Salamanca, Salamanca, Spain (Recruiting)
Study contacts
- Principal investigator: Manuel Angel Gomez Marcos, MD, PhD — Centro Asistencial Universitario de Salamanca (CAUSA)
- Study coordinator: Manuel Angel Gómez Marcos, MD, PhD
- Email: magomez@usal.es
- Phone: +346751143551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.