Clinical and Biological Characterization of Post COVID-19 Syndrome

NCT05735782 | Unknown

• 1 other identifier: PICTO-COVID-SECUELAS-00015
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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?

Conditions

Long COVID

Keywords

Post-Acute COVID-19 Syndrome; Long COVID; Post-COVID Conditions; Post Acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• IL-6, Anti-SARS-Cov-2 S-RBD IgG Antibodies and vitamin D levels

  More than 12 weeks post- acute COVID-19 episode

Other Outcomes (1)

• Circulating miRNA expression

  More than 12 weeks post- acute COVID-19 episode

Study Arms (1)

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; Diagnostic Test: Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome

Interventions

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

Case-Control

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

Case-Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living in Buenos Aires with history of COVID-19

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Arturo Jauretche National University: lead
• Hospital El Cruce: collaborator
• National University of Cuyo: collaborator
• Universidad Nacional de La Plata: collaborator
• University of Buenos Aires: collaborator

Study Sites (1)

Hospital El Cruce

San Juan Bautista, Buenos Aires, 1888, Argentina

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Antonietti, MD, MHA

  Arturo Jauretche National University

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Central Study Contacts

Laura Antonietti, MD, MHA

CONTACT

+541158544004; laurayantonietti@gmail.com

Javier Mariani, MD

CONTACT

ja_mariani@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 21, 2023
• Study Start: February 16, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

AR (1)