Other Clinical Trial - Clinical & Biological Characterization of Post

Status Recruiting

Clinical Trial 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?

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05735782
Study type	Observational
Source	Arturo Jauretche National University
Contact	Laura Antonietti, MD, MHA
Phone	+541158544004
Email	laurayantonietti@gmail.com
Status	Recruiting
Phase
Start date	February 16, 2023
Completion date	June 30, 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical and Biological Characterization of Post COVID-19 Syndrome

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms