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| Name | Class |
|---|---|
| Hospital El Cruce | OTHER |
| National University of Cuyo | OTHER |
| Universidad Nacional de La Plata | OTHER |
| University of Buenos Aires |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical, mental health and psychosocial profile of Post-COVID-19 syndrome | Diagnostic Test | Evaluation of persistent symptoms of COVID-19 and its association with psychological, cognitive and social status in comparison to a healthy control group |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial, Cognitive and Health-related Quality Of Life association with symptoms Post COVID-19 syndrome | 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) | More than 12 weeks post- acute COVID-19 episode |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6, Anti-SARS-Cov-2 S-RBD IgG Antibodies and vitamin D levels | Evaluate inflammatory, immune and vitamin D profile in post-COVID-19 | More than 12 weeks post- acute COVID-19 episode |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating miRNA expression | RNA-Seq in plasma of participants with persistent symptoms of COVID-19 and comparison | More than 12 weeks post- acute COVID-19 episode |
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:
Exclusion Criteria:
Women who report being pregnant, who are in the puerperium or lactation period at the time of the evaluation.
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.
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Adults living in Buenos Aires with history of COVID-19
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Antonietti, MD, MHA | Contact | +541158544004 | laurayantonietti@gmail.com | |
| Javier Mariani, MD | Contact | ja_mariani@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Laura Antonietti, MD, MHA | Arturo Jauretche National University | Principal Investigator |
| Javier Mariani, MD | Hospital El Cruce | Study Chair |
| Walter Manucha, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital El Cruce | Recruiting | San Juan Bautista | Buenos Aires | 1888 | Argentina |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| OTHER |
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Blood
| Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome | Diagnostic Test | Determine the inflammatory, immune profile and ventricular function in post-COVID-19 participants compared to a control group |
|
| National University of Cuyo |
| Study Chair |
| Mariela Paz, PhD | University of Buenos Aires | Study Chair |
| MartÃn Rumbo, PhD | Universidad Nacional de La Plata | Study Chair |
| Liliana Dain, PhD | University of Buenos Aires | Study Chair |
| Carlos Tajer | Hospital El Cruce | Study Chair |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |