Clinical and Biological Characterization of Post COVID-19 Syndrome
- Conditions
- Long COVID
- Interventions
- Diagnostic Test: Clinical, mental health and psychosocial profile of Post-COVID-19 syndromeDiagnostic Test: Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome
- Registration Number
- NCT05735782
- Lead Sponsor
- Arturo Jauretche National University
- Brief Summary
The goal of this observational study is to describe the symptoms that persist for more than 12 weeks after the acute episode in participants who had COVID-19, and compare the functional, socioeconomic and occupational effects with a post-COVID-19 control group without persistent symptoms after the COVID-19 acute event.
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?
- Detailed Description
Two groups of cases and one group of controls will be included. A group of cases with persistent respiratory and/or cardiovascular symptoms (cardiorespiratory cases), and another group with persistent non-cardiorespiratory symptoms.
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- Age equal to or greater than 18 years;
- 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.
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Women who report being pregnant, who are in the puerperium or lactation period at the time of the evaluation.
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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.
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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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Case-Control Clinical, mental health and psychosocial profile of Post-COVID-19 syndrome 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. Case-Control Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome 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.
- Primary Outcome Measures
Name Time Method Psychosocial, Cognitive and Health-related Quality Of Life association with symptoms Post COVID-19 syndrome More than 12 weeks post- acute COVID-19 episode Assessment of symptoms and health-related quality of life (ISARIC), fatigue (Chalder fatigue scale and SPHERE questionnaire) and psychosocial evaluation(PHQ-9 and GAD-7 questionnaires)
- Secondary Outcome Measures
Name Time Method IL-6, Anti-SARS-Cov-2 S-RBD IgG Antibodies and vitamin D levels More than 12 weeks post- acute COVID-19 episode Evaluate inflammatory, immune and vitamin D profile in post-COVID-19
Trial Locations
- Locations (1)
Hospital El Cruce
🇦🇷Florencio Varela, Buenos Aires, Argentina