Teaching and Research Healthcare Center of the University of Magallanes (CADI-UMAG)
Punta Arenas, Magllanes and Chilean Antartic Region, 6200000, Chile
NCT Number: NCT05855382
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.
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Notify Me18 year–100 year
All sexes
Observational
Punta Arenas, Magllanes and Chilean Antartic Region, 6200000, Chile
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 13 months
Time frame: 3 months
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.
Time frame: 3 months
Beck Anxiety Scale (BAI)
Time frame: 3 months
D2-R test of attention
Time frame: 3 months
Wechsler Adult Intelligence Scale (WAIS)
Time frame: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
COVID-19 related stress questionnaire based on the Perceived Stress Scale
Time frame: 3 months
Normal activities and work productivity questionnaire; daily diaries
Time frame: 3 months
Full blood count
Time frame: 3 months
Serum chemistry test
Time frame: 6 months
Interleukin-8 (IL-8)
Time frame: 6 months
Interleukin-1β (IL-1β)
Time frame: 6 months
Interleukin-6 (IL-6)
Time frame: 6 months
Interleukin-10 (IL-10)
Time frame: 6 months
Tumor Necrosis Factor (TNF)
Time frame: 6 months
Interleukin-12 (IL-12p70)
Time frame: 6 months
DNA sequencing results
Time frame: 6 months
Quantify different lymphocyte subpopulations in persistent COVID-19
Time frame: 6 months
Quantify Age-Associated B Cells and Their Potential Role in Persistent COVID-19 Pathogenesis
Time frame: 6 months
Fatigue Assessment Scale (FAS)
Time frame: 6 months
Body Composition Analysis Assessment
Time frame: 6 months
Hand Grip Strength Test
Time frame: 6 months
Maximum inspiratory pressure test (MIP test)
Time frame: 8 months
Clinical determination of whether the patient has persistent COVID-19 or not is necessary for referral to the appropriate healthcare system
Time frame: 2 months
Heart Rate Variability (HRV) analysis
Time frame: 2 months
walk test (distance): 3D temporal scanning system for gait analysis by photogrammetry
Time frame: 2 months
Postural Stability and Control Assessment Using Balance Tests
Time frame: 2 months
Spirometry: measurement of respiratory flows and volumes.
Universidad de Magallanes
Other
A Prevalence Study of Persistent COVID-19 in Punta Arenas, Magallanes and Chilean Antarctic Region
Acronym: PCOV-19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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