Clinical and Biological Characterization of Post COVID-19 Syndrome
Study Details
Study Description
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:
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What are the characteristics of symptoms that persist for more than 12 weeks in participants who have had COVID19 in the last year?
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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?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: 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 Test: 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
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Outcome Measures
Primary Outcome Measures
- 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
- 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
Other Outcome Measures
- Circulating miRNA expression [More than 12 weeks post- acute COVID-19 episode]
RNA-Seq in plasma of participants with persistent symptoms of COVID-19 and comparison
Eligibility Criteria
Criteria
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. For participation in the study, people who meet the following inclusion criteria and none of the exclusion criteria will be considered.
Inclusion Criteria:
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Age equal to or greater than 18 years;
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Documented SARS-CoV-2 infection by PCR or antigen test;
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Ability to understand the objectives of the study;
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Acceptance to participate in the study and willingness to sign the informed consent.
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Permanent residence in Buenos Aires Metropolitan Area.
Exclusion Criteria:
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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:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital El Cruce | Florencio Varela | Buenos Aires | Argentina | 1888 |
Sponsors and Collaborators
- Arturo Jauretche National University
- Hospital El Cruce
- National University of Cuyo
- Universidad Nacional de La Plata
- University of Buenos Aires
Investigators
- Principal Investigator: Laura Antonietti, MD, MHA, Arturo Jauretche National University
- Study Chair: Javier Mariani, MD, Hospital El Cruce
- Study Chair: Walter Manucha, PhD, National University of Cuyo
- Study Chair: Mariela Paz, PhD, University of Buenos Aires
- Study Chair: Martín Rumbo, PhD, Universidad Nacional de La Plata
- Study Chair: Liliana Dain, PhD, University of Buenos Aires
- Study Chair: Carlos Tajer, Hospital El Cruce
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PICTO-COVID-SECUELAS-00015