Prevalence of Persistent COVID-19 in Punta Arenas, Magallanes and Chilean Antarctic Region

Recruiting

• Conditions: COVID-19
• Interventions: Other: Persistent COVID-19

• Registration Number: NCT05855382
• Lead Sponsor: Universidad de Magallanes

Brief Summary

This cross-sectional observational study aims to determine the prevalence of Persistent COVID-19 in 282 individuals in Punta Arenas, Magallanes and Chilean Antarctic Region. Persistent COVID-19 is a complex array of symptoms that persist or emerge for more than 4 weeks beyond SARS-CoV-2 infection. Recent studies suggest that up to 80% of survivors may develop chronic multi-organ dysfunction due to persistent inflammation and immune dysregulation, making it an ongoing public health concern worldwide.

The study aims to (1) describe and establish the frequency of physical and psychological signs and symptoms in adult patients who have tested positive for COVID-19, (2) identify individuals who meet the WHO case definition of Persistent COVID-19 in Chile, (3) explore risk factors associated with persistent COVID-19 to guide intervention strategies, and (4) explore inflammatory and molecular biomarkers associated with persistent COVID-19.

The research project utilizes a stratified random sampling with a mixed-methods embedded design. In the first phase, individuals diagnosed with COVID-19 will be recruited and followed up to complete the study's sample universe. A sociodemographic survey, blood sampling (including complete blood count, biochemical profile, immunoglobulin mutational status analysis, and analysis of inflammatory biomarkers), and a battery of psychological tests will be administered. In the second phase, kinesiology studies and medical consultation and evaluation will be conducted to determine if individuals have Persistent COVID-19 and to derive them to the healthcare network. In the final follow-up phase, participants diagnosed with Persistent COVID-19 will be invited to undergo musculoskeletal and respiratory assessments to complete the diagnosis of symptoms associated with the pathology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-07
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-11
• Study Start: 2023-05-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Age ≥ 18 years
• Individuals must be included in the COVID-19 monitoring database by the SEREMI of Health in Punta Arenas between July 2022 and July 2023.
• Patients able to give informed consent.

Exclusion Criteria

• Age < 18 years
• Any physical, mental, immunosuppressive, or social condition that, in the investigator's judgment, might interfere with the completion of the baseline assessments and evaluations.
• Individuals who are digitally illiterate and do not have access to nearby networks to support them during the process.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19	Persistent COVID-19	Adults with at least one positive SARS-CoV-2 RT-qPCR test

Primary Outcome Measures

Name	Time	Method
To determine the prevalence of persistent COVID-19 in a cohort of patients in Punta Arenas	13 months

Secondary Outcome Measures

Name	Time	Method
Sleep quality and disorders	3 months	Pittsburgh Sleep Quality Index (PSQI)
Sociodemographic data questionnaire	3 months	to determine the number of prior illnesses, medical treatments, and vaccination records, as well as the quality of life scales, persistent COVID-19 symptoms through self-reported survey data, and Informed Consent Comprehension Questionnaire.
Standard laboratory parameters	3 months	Serum chemistry test
Inflammatory Biomarkers	6 months	Interleukin-12 (IL-12p70)
Psychological profiles	3 months	Wechsler Adult Intelligence Scale (WAIS)
Function of the musculoskeletal system	6 months	Maximum inspiratory pressure test (MIP test)
Psychosocial exposures	3 months	Normal activities and work productivity questionnaire; daily diaries
Immunological repertoire associated with persistent COVID-19	6 months	DNA sequencing results
Flow Cytometry Immunophenotyping	6 months	Quantify Age-Associated B Cells and Their Potential Role in Persistent COVID-19 Pathogenesis
Diagnosis of prevalent COVID-19	8 months	Clinical determination of whether the patient has persistent COVID-19 or not is necessary for referral to the appropriate healthcare system

Trial Locations

Locations (1)

Teaching and Research Healthcare Center of the University of Magallanes (CADI-UMAG); 🇨🇱 Punta Arenas, Magllanes And Chilean Antartic Region, Chile