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

COVID-19 Clinical Trial

— PCOV-19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855382
• Other study ID #: FIC-R 40036196-0
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: January 15, 2025

Study information

• Verified date: June 2024
• Source: Universidad de Magallanes
• Contact: Leyla Huirimilla Casanova, psychologist
• Phone: +569 34206933.
• Email: fic.longcovid[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: January 15, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Chile	Teaching and Research Healthcare Center of the University of Magallanes (CADI-UMAG)	Punta Arenas	Magllanes And Chilean Antartic Region

Sponsors (4)

Lead Sponsor	Collaborator
Universidad de Magallanes	Centro Asistencial Docente e Investigación de la Universidad Magallanes (CADI-UMAG), Universidad de Santiago de Chile, University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (3)

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 — View Citation

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 Ch — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Musculoskeletal Capacity	Heart Rate Variability (HRV) analysis	2 months
Other	Musculoskeletal Capacity	walk test (distance): 3D temporal scanning system for gait analysis by photogrammetry	2 months
Other	Musculoskeletal Capacity	Postural Stability and Control Assessment Using Balance Tests	2 months
Other	Respiratory function:	Spirometry: measurement of respiratory flows and volumes.	2 months
Primary	To determine the prevalence of persistent COVID-19 in a cohort of patients in Punta Arenas		13 months
Secondary	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
Secondary	Psychological profiles	Beck Anxiety Scale (BAI)	3 months
Secondary	Psychological profiles	D2-R test of attention	3 months
Secondary	Psychological profiles	Wechsler Adult Intelligence Scale (WAIS)	3 months
Secondary	Sleep quality and disorders	Pittsburgh Sleep Quality Index (PSQI)	3 months
Secondary	Psychosocial exposures	COVID-19 related stress questionnaire based on the Perceived Stress Scale	3 months
Secondary	Psychosocial exposures	Normal activities and work productivity questionnaire; daily diaries	3 months
Secondary	Standard laboratory parameters	Full blood count	3 months
Secondary	Standard laboratory parameters	Serum chemistry test	3 months
Secondary	Inflammatory Biomarkers	Interleukin-8 (IL-8)	6 months
Secondary	Inflammatory Biomarkers	Interleukin-1ß (IL-1ß)	6 months
Secondary	Inflammatory Biomarkers	Interleukin-6 (IL-6)	6 months
Secondary	Inflammatory Biomarkers	Interleukin-10 (IL-10)	6 months
Secondary	Inflammatory Biomarkers	Tumor Necrosis Factor (TNF)	6 months
Secondary	Inflammatory Biomarkers	Interleukin-12 (IL-12p70)	6 months
Secondary	Immunological repertoire associated with persistent COVID-19	DNA sequencing results	6 months
Secondary	Flow Cytometry Immunophenotyping	Quantify different lymphocyte subpopulations in persistent COVID-19	6 months
Secondary	Flow Cytometry Immunophenotyping	Quantify Age-Associated B Cells and Their Potential Role in Persistent COVID-19 Pathogenesis	6 months
Secondary	Function of the musculoskeletal system	Fatigue Assessment Scale (FAS)	6 months
Secondary	Function of the musculoskeletal system	Body Composition Analysis Assessment	6 months
Secondary	Function of the musculoskeletal system	Hand Grip Strength Test	6 months
Secondary	Function of the musculoskeletal system	Maximum inspiratory pressure test (MIP test)	6 months
Secondary	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

External Links

•   Enrolling for the study