Clinical trial NCT05855382: Prevalence of Persistent COVID-19 in Punta Arenas, Magallanes and Chilean Antarctic Region
Official title: A Prevalence Study of Persistent COVID-19 in Punta Arenas, Magallanes and Chilean Antarctic Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Universidad de Magallanes
Sponsor class: OTHER
Collaborators: name: Centro Asistencial Docente e Investigación de la Universidad Magallanes (CADI-UMAG)
name: University of Chile
name: Universidad de Santiago de Chile
First posted: 2023-05-11
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To determine the prevalence of persistent COVID-19 in a cohort of patients in Punta Arenas
timeFrame: 13 months
Secondary outcomes:
measure: Sociodemographic data questionnaire
timeFrame: 3 months
measure: Psychological profiles
timeFrame: 3 months
measure: Psychological profiles
timeFrame: 3 months
measure: Psychological profiles
timeFrame: 3 months
measure: Sleep quality and disorders
timeFrame: 3 months
measure: Psychosocial exposures
timeFrame: 3 months
measure: Psychosocial exposures
timeFrame: 3 months
measure: Standard laboratory parameters
timeFrame: 3 months
measure: Standard laboratory parameters
timeFrame: 3 months
measure: Inflammatory Biomarkers
timeFrame: 6 months
measure: Inflammatory Biomarkers
timeFrame: 6 months
measure: Inflammatory Biomarkers
timeFrame: 6 months
measure: Inflammatory Biomarkers
timeFrame: 6 months
measure: Inflammatory Biomarkers
timeFrame: 6 months
measure: Inflammatory Biomarkers
timeFrame: 6 months
measure: Immunological repertoire associated with persistent COVID-19
timeFrame: 6 months
measure: Flow Cytometry Immunophenotyping
timeFrame: 6 months
measure: Flow Cytometry Immunophenotyping
timeFrame: 6 months
measure: Function of the musculoskeletal system
timeFrame: 6 months
measure: Function of the musculoskeletal system
timeFrame: 6 months
measure: Function of the musculoskeletal system
timeFrame: 6 months
measure: Function of the musculoskeletal system
timeFrame: 6 months
measure: Diagnosis of prevalent COVID-19
timeFrame: 8 months
Other outcomes:
measure: Musculoskeletal Capacity
timeFrame: 2 months
measure: Musculoskeletal Capacity
timeFrame: 2 months
measure: Musculoskeletal Capacity
timeFrame: 2 months
measure: Respiratory function:
timeFrame: 2 months
Locations:
city: Punta Arenas
country: Chile
facility: Teaching and Research Healthcare Center of the University of Magallanes (CADI-UMAG)
state: Magllanes And Chilean Antartic Region
Study officials:
References:
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 Chile Reveals New Insights into the Spike's Dynamics. Viruses. 2021 May 11;13(5):883. doi: 10.3390/v13050883.
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;11:1140353. doi: 10.3389/fpubh.2023.1140353. eCollection 2023.
citation: 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.