NCT05735782

Clinical and Biological Characterization of Post COVID-19 Syndrome

Association of Symptoms, Clinical and Biochemical Characteristics in Post COVID-19 Syndrome: a Case-control Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Arturo Jauretche National University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Long COVID

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-16
• Primary completion: 2023-04-30
• Completion: 2023-06-30
• First posted: 2023-02-21
• Last updated: 2023-02-21

Locations

1 site across 1 country: Argentina