Skip to main content
OpenTrials
Completed

NCT Number: NCT05855382

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Teaching and Research Healthcare Center of the University of Magallanes (CADI-UMAG)

Punta Arenas, Magllanes and Chilean Antartic Region, 6200000, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Persistent COVID-19

Other

To determine the prevalence of persistent COVID-19 diagnosis in the current study, we will identify adults between 18 and 100 years of age who have had at least one positive SARS-CoV-2 RT-qPCR test from the COVID-19 database maintained by the SEREMI of Health in Punta Arenas between July 2022 and July 2023.

Primary outcomes

  1. To determine the prevalence of persistent COVID-19 in a cohort of patients in Punta Arenas

    Time frame: 13 months

Secondary outcomes

  1. Sociodemographic data questionnaire

    Time frame: 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.

  2. Psychological profiles

    Time frame: 3 months

    Beck Anxiety Scale (BAI)

  3. Psychological profiles

    Time frame: 3 months

    D2-R test of attention

  4. Psychological profiles

    Time frame: 3 months

    Wechsler Adult Intelligence Scale (WAIS)

  5. Sleep quality and disorders

    Time frame: 3 months

    Pittsburgh Sleep Quality Index (PSQI)

  6. Psychosocial exposures

    Time frame: 3 months

    COVID-19 related stress questionnaire based on the Perceived Stress Scale

  7. Psychosocial exposures

    Time frame: 3 months

    Normal activities and work productivity questionnaire; daily diaries

  8. Standard laboratory parameters

    Time frame: 3 months

    Full blood count

  9. Standard laboratory parameters

    Time frame: 3 months

    Serum chemistry test

  10. Inflammatory Biomarkers

    Time frame: 6 months

    Interleukin-8 (IL-8)

  11. Inflammatory Biomarkers

    Time frame: 6 months

    Interleukin-1β (IL-1β)

  12. Inflammatory Biomarkers

    Time frame: 6 months

    Interleukin-6 (IL-6)

  13. Inflammatory Biomarkers

    Time frame: 6 months

    Interleukin-10 (IL-10)

  14. Inflammatory Biomarkers

    Time frame: 6 months

    Tumor Necrosis Factor (TNF)

  15. Inflammatory Biomarkers

    Time frame: 6 months

    Interleukin-12 (IL-12p70)

  16. Immunological repertoire associated with persistent COVID-19

    Time frame: 6 months

    DNA sequencing results

  17. Flow Cytometry Immunophenotyping

    Time frame: 6 months

    Quantify different lymphocyte subpopulations in persistent COVID-19

  18. Flow Cytometry Immunophenotyping

    Time frame: 6 months

    Quantify Age-Associated B Cells and Their Potential Role in Persistent COVID-19 Pathogenesis

  19. Function of the musculoskeletal system

    Time frame: 6 months

    Fatigue Assessment Scale (FAS)

  20. Function of the musculoskeletal system

    Time frame: 6 months

    Body Composition Analysis Assessment

  21. Function of the musculoskeletal system

    Time frame: 6 months

    Hand Grip Strength Test

  22. Function of the musculoskeletal system

    Time frame: 6 months

    Maximum inspiratory pressure test (MIP test)

  23. Diagnosis of prevalent COVID-19

    Time frame: 8 months

    Clinical determination of whether the patient has persistent COVID-19 or not is necessary for referral to the appropriate healthcare system

Other outcomes

  1. Musculoskeletal Capacity

    Time frame: 2 months

    Heart Rate Variability (HRV) analysis

  2. Musculoskeletal Capacity

    Time frame: 2 months

    walk test (distance): 3D temporal scanning system for gait analysis by photogrammetry

  3. Musculoskeletal Capacity

    Time frame: 2 months

    Postural Stability and Control Assessment Using Balance Tests

  4. Respiratory function:

    Time frame: 2 months

    Spirometry: measurement of respiratory flows and volumes.

Sponsors and collaborators

Lead sponsor

Universidad de Magallanes

Other

Collaborators

  • Centro Asistencial Docente e Investigación de la Universidad Magallanes (CADI-UMAG)
  • Universidad de Santiago de Chile
  • University of Chile

Registry information

Official study title

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

Acronym: PCOV-19

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 11, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.