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

NCT05855382 | Recruiting DMC

• 1 other identifier: FIC-R 40036196-0
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

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

  13 months

Secondary Outcomes (23)

• Sociodemographic data questionnaire

  3 months

• Psychological profiles

  3 months

• Psychological profiles

  3 months

• Psychological profiles

  3 months

• Sleep quality and disorders

  3 months

Other Outcomes (4)

• Musculoskeletal Capacity

  2 months

• Musculoskeletal Capacity

  2 months

• Musculoskeletal Capacity

  2 months

Study Arms (1)

COVID-19

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

Other: Persistent COVID-19

Interventions

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.

COVID-19

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

To identify potential participants for this population-based study with stratified random sampling, we also considered the following eligibility criteria: (1) Diagnosed SARS-CoV-2 infection confirmed by RT-qPCR test (2) residency in Punta Arenas, (3) recruitment messages via phone calls, text messages, emails, and social media postings, and (4) referrals from collaborating healthcare providers.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

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

RECRUITING

Related Publications (4)

• 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.

  PMID: 34064904 RESULT

• 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.

  PMID: 37113165 RESULT

• 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.

  PMID: 36285967 RESULT

• 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.

  PMID: 40447416 DERIVED

Related Links

• Enrolling for the study

Biospecimen

Retention: SAMPLES WITH DNA

* Full blood count: red cell count, haemoglobin, haematocrit, mean cellular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), red cell distribution width (RDW), white cell count and differential (neutrophil count, lymphocyte count, monocyte count, eosinophil count, and basophil count), and platelet count. * Biochemical profile: Urea/urea nitrogen, Creatinine, Total protein, Albumin,Total bilirubin, Alkaline phosphatase (ALP),Transaminases GOT/GPT, Uric acid, Total cholesterol, Triglycerides, Glucose, Calcium, Phosphorus. * Vitamin D. * Blood sample molecular analysis: inflammatory biomarkers(IL-8, IL-1β, IL-6, IL-10, TNF e IL-12p70), lymphocyte subpopulations, Age-associated B cells (ABCs), Immunological repertoire. * DNA extraction for genotyping and sequencing at the Centro Austral de Tecnología Genómica (cATG). * Additional peripheral blood mononuclear cell (PBMC) and serum samples will be stored for possible future analysis.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Leyla Huirimilla Casanova, psychologist

CONTACT

+569 34206933.; fic.longcovid@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 13 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 11, 2023
• Study Start: May 15, 2023
• Primary Completion: December 30, 2024
• Study Completion: January 15, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following our data is cleaned, quality checked, and analyzed, we will make the data available to the general research community. All data made available for public use will be de-identified data, i.e., stripped of private, protected health information that could be used to deduce the identity of individual subjects, in compliance with the Rule.
• Access Criteria: PPCov-19 Study website to be determined

Locations

CL (1)