Long COVID
Conditions
Keywords
Post-Acute COVID-19 Syndrome, Long COVID, Post-COVID Conditions, Post Acute COVID-19 Syndrome
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).
Interventions
DIAGNOSTIC_TESTClinical, 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_TESTDiagnostic 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
Sponsors
Hospital El Cruce
National University of Cuyo
Universidad Nacional de La Plata
University of Buenos Aires
Arturo Jauretche National University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Argentina
Contacts
Primary ContactLaura Antonietti, MD, MHA
Backup ContactJavier Mariani, MD
Outcome results
None listed