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临床试验/NCT05855382
NCT05855382已完成不适用

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

Universidad de Magallanes2 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
282
试验地点
2
主要终点
To determine the prevalence of persistent COVID-19 in a cohort of patients in Punta Arenas

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • Patients able to give informed consent.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 13 months

次要结局

  • Sociodemographic data questionnaire(3 months)
  • Sleep quality and disorders(3 months)
  • Immunological repertoire associated with persistent COVID-19(6 months)
  • Diagnosis of prevalent COVID-19(8 months)
  • Psychological profiles(3 months)
  • Psychosocial exposures(3 months)
  • Standard laboratory parameters(3 months)
  • Inflammatory Biomarkers(6 months)
  • Flow Cytometry Immunophenotyping(6 months)
  • Function of the musculoskeletal system(6 months)

研究者

发起方
Universidad de Magallanes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcelo A. Navarrete Signorile

Principal Investigator

Universidad de Magallanes

研究点 (2)

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