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

NCT ID: NCT05855382

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2025-01-15

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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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COVID-19

Adults with at least one positive SARS-CoV-2 RT-qPCR test

Persistent COVID-19

Intervention Type 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.

Interventions

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Persistent COVID-19

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Asistencial Docente e Investigación de la Universidad Magallanes (CADI-UMAG)

UNKNOWN

Sponsor Role collaborator

University of Chile

OTHER

Sponsor Role collaborator

Universidad de Santiago de Chile

OTHER

Sponsor Role collaborator

Universidad de Magallanes

OTHER

Sponsor Role lead

Responsible Party

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Marcelo A. Navarrete Signorile

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Punta Arenas, Magllanes and Chilean Antartic Region, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Leyla Huirimilla Casanova, psychologist

Role: CONTACT

+569 34206933.

Facility Contacts

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Leyla Huirimilla Casanova

Role: primary

+56934206933.

References

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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.

Reference Type RESULT
PMID: 34064904 (View on PubMed)

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.

Reference Type RESULT
PMID: 37113165 (View on PubMed)

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.

Reference Type RESULT
PMID: 36285967 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40447416 (View on PubMed)

Related Links

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Other Identifiers

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FIC-R 40036196-0

Identifier Type: -

Identifier Source: org_study_id

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