Persistent COVID-19ICOPERNCT05819840
Vascular Structure, Vascular Function and Vascular Aging in Adults Diagnosed With Persistent COVID
An observational study of Persistent COVID-19 and Quality of Life, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
The ICOPER study aims to analyze the structure, vascular function, vascular aging and determining factors in 300 adults diagnosed with Persistent Covid in the field of Primary Health Care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Persistent COVID-19, Quality of Life, Lifestyles
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Through consecutive sampling, 300 subjects will be selected who meet the WHO clinical definition of Persistent Covid established by international Delphi consensus. The subjects will be recruited from the existing records in the Primary Care consultations and in the Internal Medicine Persistent Covid consultation in the Salamanca health area.
Who may be able to join
- History of probable or confirmed SARS-CoV-2 infection, usually 3 months after onset, with symptoms that last at least 2 months and cannot be explained by an alternative diagnosis.
- Common symptoms should include fatigue, shortness of breath, and cognitive dysfunction, and an impact on daily functioning.
Who cannot join
- Subjects in a terminal situation.
- Inability to travel to health centers.
- Presenting a history of cardiovascular disease (ischemic heart disease or cerebrovascular disease).
- Glomerular filtration rate of less than 30%.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Primary Care Research Unit of Salamanca (APISAL)
Salamanca, 37005
Olaya Tamayo Morales, 923177831, olayatm@usal.es
About this study
Official title: Vascular Structure, Vascular Function and Vascular Aging in Adults Diagnosed With Persistent COVID. ICOPER Study.
The ICOPER study aims to analyze the structure, vascular function, vascular aging and determining factors in 300 adults diagnosed with Persistent Covid in the field of Primary Health Care.
Read the detailed description
Objective: To analyze the structure, the vascular function, the vascular aging and the determining factors in adults with a diagnosis of Persistent Covid and the differences by gender.
Design: Cross-sectional descriptive observational study. Setting: The study will be carried out at the Salamanca Primary Care Research Unit (APISAL). Study Subjects: The study includes the basis of the Persistent Covid Monographic consultation in the Internal Medicine Service of the University Hospital of Salamanca and the subjects with the diagnosis of Persistent Covid in the MEDORA Primary Care clinical history. Thus, 300 subjects have been obtained who are diagnosed with Persistent Covid, who meet the diagnostic criteria established by the Spanish Society of General and Family Physicians and sign the informed consent.
Measurements: The variables reflected in the Integrated Assistance process for the Care of People Affected by SARS CoV-2 of the Junta de Castilla y León will be collected, to evaluate the functional status of the patient and persistent symptoms, their impact on activities of daily life and quality of life of patients with Persistent Covid and the perception of their health. Lifestyles (diet, physical activity, tobacco and alcohol), psychological factors and cognitive impairment will be collected using validated questionnaires, and physical activity will be objectively measured with a 7-day pedometer. Vascular structure and function will be analyzed by measuring the thickness of the carotid intima media (Sonosite Micromax); pulse wave analysis and carotid-femoral pulse wave velocity (VOPcf) (Sphygmocor System). Cardio Ankle Vascular Index (CAVI), ankle-brachial pulse wave velocity (VOPbt) and ankle-brachial index (Vasera VS-2000®). Vascular aging will be calculated using the 10 and 90 percentiles of the VOPcf and the VOPbt. Demographic, analytical variables and to assess retinal, cardiac, renal, cerebral vascular lesion and cardiovascular risk will be collected.
- Conditions
- Persistent COVID-19, Quality of Life, Lifestyles, Arterial Stiffness
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity
Measurement by SphygmoCor System (meters/seg)
Measured: 1 year
Secondary outcomes (8)
Carotid intima-media thickness (IMT)
Measurement by Sonosite Micromax Ultrasound (mm)
Measured: 1 year
Cardio Ankle Vascular Index (CAVI)
Measurement by Vasera device 2000 (not units)
Measured: 1 year
Physical Activity
World Questionnaire on Physical Activity (GPAQ)
Measured: 1 year
Eating habits
Mediterranean Diet Adherence PREDIMED Questionnaire
Measured: 1 year
Smoking
Measurement by a questionnaire of four questions adapted from the WHO MONICA study
Measured: 1 year
Drinking habits
Measurement by a frequency alcohol questionnaire (units/day)
Measured: 1 year
Psychological factors
Goldberg Anxiety and Depression Scale
Measured: 1 year
Cognitive evaluation
Measurement by Montreal Cognitive Assessment (MOCA) (points). Range: 0-30 points. A score of 26 points or above is considered normal.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start9 Mar 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Persistent COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819840
- Sponsor's protocol ID
- GRS2501/B/22
- Acronym
- ICOPER
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vicente-Prieto A, Lugones-Sanchez C, Vicente-Gabriel S, Saldana-Ruiz C, Gonzalez-Sanchez S, Conde-Martin S, Rodriguez-Sanchez E, Garcia-Ortiz L, Gomez-Sanchez M, Gomez-Sanchez L, Gomez-Marcos MA, Eva-Adic Investigators Group. Alcohol Consumption Patterns and Peripheral Arterial Stiffness in Young Adults: Sex-Specific Findings from the EVA-Adic Study. Nutrients. 2026 Jan 26;18(3):411. doi: 10.3390/nu18030411.
PubMed 41683236Vicente-Gabriel S, Lugones-Sanchez C, Tamayo-Morales O, Vicente Prieto A, Gonzalez-Sanchez S, Conde Martin S, Gomez-Sanchez M, Rodriguez-Sanchez E, Garcia-Ortiz L, Gomez-Sanchez L, Gomez-Marcos MA; EVA-Adic Investigators Group. Relationship between addictions and obesity, physical activity and vascular aging in young adults (EVA-Adic study): a research protocol of a cross-sectional study. Front Public Health. 2024 Jan 26;12:1322437. doi: 10.3389/fpubh.2024.1322437. eCollection 2024.
PubMed 38344236Gomez-Sanchez L, Tamayo-Morales O, Suarez-Moreno N, Bermejo-Martin JF, Dominguez-Martin A, Martin-Oterino JA, Martin-Gonzalez JI, Gonzalez-Calle D, Garcia-Garcia A, Lugones-Sanchez C, Gonzalez-Sanchez S, Jimenez-Gomez R, Garcia-Ortiz L, Gomez-Marcos MA, Navarro-Matias E; ICOPER investigators group. Relationship between the structure, function and endothelial damage, and vascular ageing and the biopsychological situation in adults diagnosed with persistent COVID (BioICOPER study). A research protocol of a cross-sectional study. Front Physiol. 2023 Sep 12;14:1236430. doi: 10.3389/fphys.2023.1236430. eCollection 2023.
PubMed 37772064
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Structure, Vascular Function and Vascular Aging in Adults Diagnosed With Persistent COVID. ICOPER Study.
- ClinicalTrials.gov ID
- NCT05819840
- Acronym / sponsor ID
- ICOPER / GRS2501/B/22
- Conditions
- Persistent COVID-19, Quality of Life, Lifestyles, Arterial Stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ICOPER study aims to analyze the structure, vascular function, vascular aging and determining factors in 300 adults diagnosed with Persistent Covid in the field of Primary Health Care.
Detailed description
Objective: To analyze the structure, the vascular function, the vascular aging and the determining factors in adults with a diagnosis of Persistent Covid and the differences by gender.
Design: Cross-sectional descriptive observational study. Setting: The study will be carried out at the Salamanca Primary Care Research Unit (APISAL). Study Subjects: The study includes the basis of the Persistent Covid Monographic consultation in the Internal Medicine Service of the University Hospital of Salamanca and the subjects with the diagnosis of Persistent Covid in the MEDORA Primary Care clinical history. Thus, 300 subjects have been obtained who are diagnosed with Persistent Covid, who meet the diagnostic criteria established by the Spanish Society of General and Family Physicians and sign the informed consent.
Measurements: The variables reflected in the Integrated Assistance process for the Care of People Affected by SARS CoV-2 of the Junta de Castilla y León will be collected, to evaluate the functional status of the patient and persistent symptoms, their impact on activities of daily life and quality of life of patients with Persistent Covid and the perception of their health. Lifestyles (diet, physical activity, tobacco and alcohol), psychological factors and cognitive impairment will be collected using validated questionnaires, and physical activity will be objectively measured with a 7-day pedometer. Vascular structure and function will be analyzed by measuring the thickness of the carotid intima media (Sonosite Micromax); pulse wave analysis and carotid-femoral pulse wave velocity (VOPcf) (Sphygmocor System). Cardio Ankle Vascular Index (CAVI), ankle-brachial pulse wave velocity (VOPbt) and ankle-brachial index (Vasera VS-2000®). Vascular aging will be calculated using the 10 and 90 percentiles of the VOPcf and the VOPbt. Demographic, analytical variables and to assess retinal, cardiac, renal, cerebral vascular lesion and cardiovascular risk will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Through consecutive sampling, 300 subjects will be selected who meet the WHO clinical definition of Persistent Covid established by international Delphi consensus. The subjects will be recruited from the existing records in the Primary Care consultations and in the Internal Medicine Persistent Covid consultation in the Salamanca health area.
Key inclusion criteria (2 listed)
- History of probable or confirmed SARS-CoV-2 infection, usually 3 months after onset, with symptoms that last at least 2 months and cannot be explained by an alternative diagnosis.
- Common symptoms should include fatigue, shortness of breath, and cognitive dysfunction, and an impact on daily functioning.
Key exclusion criteria (4 listed)
- Subjects in a terminal situation.
- Inability to travel to health centers.
- Presenting a history of cardiovascular disease (ischemic heart disease or cerebrovascular disease).
- Glomerular filtration rate of less than 30%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulse Wave Velocity
Time frame: 1 year
Measurement by SphygmoCor System (meters/seg)
8 secondary outcomes
Carotid intima-media thickness (IMT)
Time frame: 1 year
Cardio Ankle Vascular Index (CAVI)
Time frame: 1 year
Physical Activity
Time frame: 1 year
Eating habits
Time frame: 1 year
Smoking
Time frame: 1 year
Drinking habits
Time frame: 1 year
Psychological factors
Time frame: 1 year
Cognitive evaluation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 41683236Vicente-Prieto A, Lugones-Sanchez C, Vicente-Gabriel S, Saldana-Ruiz C, Gonzalez-Sanchez S, Conde-Martin S, Rodriguez-Sanchez E, Garcia-Ortiz L, Gomez-Sanchez M, Gomez-Sanchez L, Gomez-Marcos MA, Eva-Adic Investigators Group. Alcohol Consumption Patterns and Peripheral Arterial Stiffness in Young Adults: Sex-Specific Findings from the EVA-Adic Study. Nutrients. 2026 Jan 26;18(3):411. doi: 10.3390/nu18030411.
- Derived from this study: PubMed 38344236Vicente-Gabriel S, Lugones-Sanchez C, Tamayo-Morales O, Vicente Prieto A, Gonzalez-Sanchez S, Conde Martin S, Gomez-Sanchez M, Rodriguez-Sanchez E, Garcia-Ortiz L, Gomez-Sanchez L, Gomez-Marcos MA; EVA-Adic Investigators Group. Relationship between addictions and obesity, physical activity and vascular aging in young adults (EVA-Adic study): a research protocol of a cross-sectional study. Front Public Health. 2024 Jan 26;12:1322437. doi: 10.3389/fpubh.2024.1322437. eCollection 2024.
- Derived from this study: PubMed 37772064Gomez-Sanchez L, Tamayo-Morales O, Suarez-Moreno N, Bermejo-Martin JF, Dominguez-Martin A, Martin-Oterino JA, Martin-Gonzalez JI, Gonzalez-Calle D, Garcia-Garcia A, Lugones-Sanchez C, Gonzalez-Sanchez S, Jimenez-Gomez R, Garcia-Ortiz L, Gomez-Marcos MA, Navarro-Matias E; ICOPER investigators group. Relationship between the structure, function and endothelial damage, and vascular ageing and the biopsychological situation in adults diagnosed with persistent COVID (BioICOPER study). A research protocol of a cross-sectional study. Front Physiol. 2023 Sep 12;14:1236430. doi: 10.3389/fphys.2023.1236430. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent COVID-19 and Quality of Life, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Navarro Matías (923177831, enavarro@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Velocity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05819840, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.