Clinical and Biological Characterization of Post COVID-19 Syndrome

February 17, 2023 updated by: Laura Antonietti, Arturo Jauretche National University

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Florencio Varela, Buenos Aires, Argentina, 1888
        • Recruiting
        • Hospital El Cruce
        • Contact:
        • Sub-Investigator:
          • Javier Mariani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults living in Buenos Aires with history of COVID-19

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. 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial, Cognitive and Health-related Quality Of Life association with symptoms Post COVID-19 syndrome
Time Frame: 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)
More than 12 weeks post- acute COVID-19 episode

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-6, Anti-SARS-Cov-2 S-RBD IgG Antibodies and vitamin D levels
Time Frame: More than 12 weeks post- acute COVID-19 episode
Evaluate inflammatory, immune and vitamin D profile in post-COVID-19
More than 12 weeks post- acute COVID-19 episode

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating miRNA expression
Time Frame: More than 12 weeks post- acute COVID-19 episode
RNA-Seq in plasma of participants with persistent symptoms of COVID-19 and comparison
More than 12 weeks post- acute COVID-19 episode

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arturo Jauretche National University

Collaborators

University of Buenos Aires
Hospital El Cruce
Universidad Nacional de La Plata
National University of Cuyo

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Estimate)

February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICTO-COVID-SECUELAS-00015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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