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Идёт набор NCT07295483

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

— Наблюдательное Persistent COVID Condition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: BioICOPER Long COVID Cohort.
Кому может быть актуально
Состояния в реестре: Persistent COVID Condition. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Официальное название

To Analyze the Determining Factors in the Evolution of Subjects Diagnosed With Long COVID at Four Years of Follow-up. BioICOPER Follow-up Study.

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Av. de Portugal 83. Planta 2 — Salamanca

Идентификаторы

NCT: NCT07295483 · BioICOPER Follow-up Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗