Clinical and Biological Characterization of Post COVID-19 Syndrome
NCT ID: NCT05735782
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2023-02-16
2023-06-30
Brief Summary
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The main questions it aims to answer are:
* What are the characteristics of symptoms that persist for more than 12 weeks in participants who have had COVID19 in the last year?
* What are the health-related quality of life and psychosocial effects in participants with persistent symptoms of COVID-19, compared to a post-COVID-19 control group without persistent symptoms after the acute episode of COVID-19?
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Detailed Description
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Participants who report at least two symptoms of intensity greater than or equal to severe will be classified as non-cardiorespiratory cases.
Controls will be participants with a history of confirmed SARS-CoV-2 infection, but without current or past persistent symptoms (ie, who resolved their symptoms during the acute episode or whose symptoms did not persist more than 4 weeks after onset).
Controls will be matched to cases by sex, age (with a margin of up to ±5 years), and time since diagnosis of the COVID-19 episode considered as the origin of post-COVID-19 symptoms in the cases (with a margin of of ±30 days).
The visit will include the application of the questionnaires for the evaluation of symptoms and quality of life associated with health, the clinical evaluation and the extraction of a blood sample.
The extraction of a blood sample will allow biochemical determinations, the complete blood count and vitamin D level to be carried out. Subsequently, an aliquot will be reserved for mechanistic evaluation (inflammatory markers, immunological and microRNA studies).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case-Control
Case group: Participants with persistent symptoms post-COVID-19 more than12 weeks after COVID-19 acute infection Control group: Participants without persistent symptoms after a COVID-19 acute infection.
Clinical, mental health and psychosocial profile of Post-COVID-19 syndrome
Evaluation of persistent symptoms of COVID-19 and its association with psychological, cognitive and social status in comparison to a healthy control group
Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome
Determine the inflammatory, immune profile and ventricular function in post-COVID-19 participants compared to a control group
Interventions
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Clinical, mental health and psychosocial profile of Post-COVID-19 syndrome
Evaluation of persistent symptoms of COVID-19 and its association with psychological, cognitive and social status in comparison to a healthy control group
Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome
Determine the inflammatory, immune profile and ventricular function in post-COVID-19 participants compared to a control group
Eligibility Criteria
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Inclusion Criteria
* Documented SARS-CoV-2 infection by PCR or antigen test;
* Ability to understand the objectives of the study;
* Acceptance to participate in the study and willingness to sign the informed consent.
* Permanent residence in Buenos Aires Metropolitan Area.
Exclusion Criteria
* People with known chronic debilitating conditions, defined as:
i. heart failure, ii. symptomatic Coronary Heart Disease, iii. Diagnosis of cancer in the last 5 years iv. symptomatic anemia, v. chronic obstructive pulmonary disease or greater than moderate asthma, vi. heart valve disease more than mild, vii. cognitive impairment prior to the diagnosis of COVID-19, viii. diagnosis of schizophrenia or depression, ix. any other condition that, at the discretion of the treating professional or the research team, may explain or justify the aforementioned symptoms.
* Participants who are undergoing an acute pathology or who have undergone it in the last 4 weeks. In this case, they may be contacted again, after the period of time considered acceptable by the treating professional or the research team to invite them to participate.
18 Years
ALL
Yes
Sponsors
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Hospital El Cruce
OTHER
National University of Cuyo
OTHER
Universidad Nacional de La Plata
OTHER
University of Buenos Aires
OTHER
Arturo Jauretche National University
OTHER
Responsible Party
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Laura Antonietti
Principal Investigator
Principal Investigators
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Laura Antonietti, MD, MHA
Role: PRINCIPAL_INVESTIGATOR
Arturo Jauretche National University
Javier Mariani, MD
Role: STUDY_CHAIR
Hospital El Cruce
Walter Manucha, PhD
Role: STUDY_CHAIR
National University of Cuyo
Mariela Paz, PhD
Role: STUDY_CHAIR
University of Buenos Aires
Martín Rumbo, PhD
Role: STUDY_CHAIR
Universidad Nacional de La Plata
Liliana Dain, PhD
Role: STUDY_CHAIR
University of Buenos Aires
Carlos Tajer
Role: STUDY_CHAIR
Hospital El Cruce
Locations
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Hospital El Cruce
San Juan Bautista, Buenos Aires, Argentina
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PICTO-COVID-SECUELAS-00015
Identifier Type: -
Identifier Source: org_study_id
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