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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05855382
Other study ID # FIC-R 40036196-0
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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