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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Other: Persistent COVID-19


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Adults with at least one positive SARS-CoV-2 RT-qPCR test | Other: Persistent COVID-19<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the prevalence of persistent COVID-19 in a cohort of patients in Punta Arenas |  | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic data questionnaire | 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. | 3 months | 
| Psychological profiles | Beck Anxiety Scale (BAI) | 3 months | 
| Psychological profiles | D2-R test of attention | 3 months | 
| Psychological profiles | Wechsler Adult Intelligence Scale (WAIS) | 3 months | 
| Sleep quality and disorders | Pittsburgh Sleep Quality Index (PSQI) | 3 months | 
| Psychosocial exposures | COVID-19 related stress questionnaire based on the Perceived Stress Scale | 3 months | 
| Psychosocial exposures | Normal activities and work productivity questionnaire; daily diaries | 3 months | 
| Standard laboratory parameters | Full blood count | 3 months | 
| Standard laboratory parameters | Serum chemistry test | 3 months | 
| Inflammatory Biomarkers | Interleukin-8 (IL-8) | 6 months | 
| Inflammatory Biomarkers | Interleukin-1β (IL-1β) | 6 months | 
| Inflammatory Biomarkers | Interleukin-6 (IL-6) | 6 months | 
| Inflammatory Biomarkers | Interleukin-10 (IL-10) | 6 months | 
| Inflammatory Biomarkers | Tumor Necrosis Factor (TNF) | 6 months | 
| Inflammatory Biomarkers | Interleukin-12 (IL-12p70) | 6 months | 
| Immunological repertoire associated with persistent COVID-19 | DNA sequencing results | 6 months | 
| Flow Cytometry Immunophenotyping | Quantify different lymphocyte subpopulations in persistent COVID-19 | 6 months | 
| Flow Cytometry Immunophenotyping | Quantify Age-Associated B Cells and Their Potential Role in Persistent COVID-19 Pathogenesis | 6 months | 
| Function of the musculoskeletal system | Fatigue Assessment Scale (FAS) | 6 months | 
| Function of the musculoskeletal system | Body Composition Analysis Assessment | 6 months | 
| Function of the musculoskeletal system | Hand Grip Strength Test | 6 months | 
| Function of the musculoskeletal system | Maximum inspiratory pressure test (MIP test) | 6 months | 
| Diagnosis of prevalent COVID-19 | Clinical determination of whether the patient has persistent COVID-19 or not is necessary for referral to the appropriate healthcare system | 8 months |