NCT05819840

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 29, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 18, 2023

Last Update Submit

June 28, 2023

Conditions

Persistent COVID-19Quality of LifeLifestylesArterial Stiffness

Outcome Measures

Primary Outcomes (1)

  • Pulse Wave Velocity

    Measurement by SphygmoCor System (meters/seg)

    1 year

Secondary Outcomes (8)

  • Carotid intima-media thickness (IMT)

    1 year

  • Cardio Ankle Vascular Index (CAVI)

    1 year

  • Physical Activity

    1 year

  • Eating habits

    1 year

  • Smoking

    1 year

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Research Unit of Salamanca (APISAL)

Salamanca, 37005, Spain

RECRUITING

Related Publications (2)

  • Vicente-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.

    PMID: 38344236DERIVED

  • Gomez-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.

    PMID: 37772064DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The analytical data closest to the patient's clinical history prior to SARS-CoV-2 infection will be collected, and the analytical data during the acute SARS-CoV-2 infection, including basal glycemia, HbA1c, TSH, profile lipid, complete blood count, liver profile, creatinine and creatinine albumin index, Vit D and PCR. At the time of inclusion, a fasting test will be carried out, including basal glycemia, HbA1c, TSH, lipid profile, complete blood count, liver profile, creatinine and creatinine albumin index, Vit D, ESR, CRP and interleukins.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Elena Navarro Matías

CONTACT

923177831enavarro@saludcastillayleon.es

Manuel Ángel Gómez Marcos

CONTACT

923177831magomez@usal.es

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 19, 2023

Study Start

March 9, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

June 29, 2023

Record last verified: 2023-04

Locations

ES(1)