- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855382
Prevalence of Persistent COVID-19 in Punta Arenas, Magallanes and Chilean Antarctic Region (PCOV-19)
A Prevalence Study 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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Magllanes and Chilean Antartic Region
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Punta Arenas, Magllanes and Chilean Antartic Region, Chile, 6200000
- Teaching and Research Healthcare Center of the University of Magallanes (CADI-UMAG)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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COVID-19
Adults with at least one positive SARS-CoV-2 RT-qPCR test
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To determine the prevalence of persistent COVID-19 in a cohort of patients in Punta Arenas
Time Frame: 13 months
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13 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sociodemographic data questionnaire
Time Frame: 3 months
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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.
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3 months
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Psychological profiles
Time Frame: 3 months
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Beck Anxiety Scale (BAI)
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3 months
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Psychological profiles
Time Frame: 3 months
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D2-R test of attention
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3 months
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Psychological profiles
Time Frame: 3 months
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Wechsler Adult Intelligence Scale (WAIS)
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3 months
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Sleep quality and disorders
Time Frame: 3 months
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Pittsburgh Sleep Quality Index (PSQI)
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3 months
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Psychosocial exposures
Time Frame: 3 months
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COVID-19 related stress questionnaire based on the Perceived Stress Scale
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3 months
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Psychosocial exposures
Time Frame: 3 months
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Normal activities and work productivity questionnaire; daily diaries
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3 months
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Standard laboratory parameters
Time Frame: 3 months
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Full blood count
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3 months
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Standard laboratory parameters
Time Frame: 3 months
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Serum chemistry test
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3 months
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Inflammatory Biomarkers
Time Frame: 6 months
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Interleukin-8 (IL-8)
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6 months
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Inflammatory Biomarkers
Time Frame: 6 months
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Interleukin-1β (IL-1β)
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6 months
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Inflammatory Biomarkers
Time Frame: 6 months
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Interleukin-6 (IL-6)
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6 months
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Inflammatory Biomarkers
Time Frame: 6 months
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Interleukin-10 (IL-10)
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6 months
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Inflammatory Biomarkers
Time Frame: 6 months
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Tumor Necrosis Factor (TNF)
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6 months
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Inflammatory Biomarkers
Time Frame: 6 months
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Interleukin-12 (IL-12p70)
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6 months
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Immunological repertoire associated with persistent COVID-19
Time Frame: 6 months
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DNA sequencing results
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6 months
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Flow Cytometry Immunophenotyping
Time Frame: 6 months
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Quantify different lymphocyte subpopulations in persistent COVID-19
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6 months
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Flow Cytometry Immunophenotyping
Time Frame: 6 months
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Quantify Age-Associated B Cells and Their Potential Role in Persistent COVID-19 Pathogenesis
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6 months
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Function of the musculoskeletal system
Time Frame: 6 months
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Fatigue Assessment Scale (FAS)
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6 months
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Function of the musculoskeletal system
Time Frame: 6 months
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Body Composition Analysis Assessment
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6 months
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Function of the musculoskeletal system
Time Frame: 6 months
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Hand Grip Strength Test
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6 months
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Function of the musculoskeletal system
Time Frame: 6 months
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Maximum inspiratory pressure test (MIP test)
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6 months
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Diagnosis of prevalent COVID-19
Time Frame: 8 months
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Clinical determination of whether the patient has persistent COVID-19 or not is necessary for referral to the appropriate healthcare system
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8 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Musculoskeletal Capacity
Time Frame: 2 months
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Heart Rate Variability (HRV) analysis
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2 months
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Musculoskeletal Capacity
Time Frame: 2 months
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walk test (distance): 3D temporal scanning system for gait analysis by photogrammetry
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2 months
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Musculoskeletal Capacity
Time Frame: 2 months
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Postural Stability and Control Assessment Using Balance Tests
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2 months
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Respiratory function:
Time Frame: 2 months
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Spirometry: measurement of respiratory flows and volumes.
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2 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Gonzalez-Puelma J, Aldridge J, Montes de Oca M, Pinto M, Uribe-Paredes R, Fernandez-Goycoolea J, Alvarez-Saravia D, Alvarez H, Encina G, Weitzel T, Munoz R, Olivera-Nappa A, Pantano S, Navarrete MA. Mutation in a SARS-CoV-2 Haplotype from Sub-Antarctic Chile Reveals New Insights into the Spike's Dynamics. Viruses. 2021 May 11;13(5):883. doi: 10.3390/v13050883.
- Sarmiento Varon L, Gonzalez-Puelma J, Medina-Ortiz D, Aldridge J, Alvarez-Saravia D, Uribe-Paredes R, Navarrete MA. The role of machine learning in health policies during the COVID-19 pandemic and in long COVID management. Front Public Health. 2023 Apr 11;11:1140353. doi: 10.3389/fpubh.2023.1140353. eCollection 2023.
- Alvarado-Aravena C, Arriaza K, Castillo-Aguilar M, Flores K, Dagnino-Subiabre A, Estrada-Goic C, Nunez-Espinosa C. Effect of Confinement on Anxiety Symptoms and Sleep Quality during the COVID-19 Pandemic. Behav Sci (Basel). 2022 Oct 17;12(10):398. doi: 10.3390/bs12100398.
- Sarmiento Varon L, Alvarez H, Huirimilla Casanova LC, Diaz Mora MP, Munoz Cuevas LA, Gonzalez-Puelma J, Espinoza K, Amarales L, Luhr Henriquez J, Retamal-Matus F, Uribe-Paredes R, Nunez-Espinosa CA, Estrada-Goic C, Bachelet VC, Lopez Nitsche MN, Navarrete MA. Estimating the prevalence of persistent symptoms after SARS-CoV-2 infection (post-COVID-19 syndrome): a regional cross-sectional study protocol. BMJ Open. 2025 May 30;15(5):e093844. doi: 10.1136/bmjopen-2024-093844.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIC-R 40036196-0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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