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临床试验/NCT04964115
NCT04964115进行中(未招募)不适用

Post Acute Sequelae of SARS-CoV-2

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
500
试验地点
1
主要终点
Natural history of recovery from COVID-19

研究概览

简要总结

COVID-19, a novel coronavirus, has caused widespread mortality and morbidity since it emerged in 2019. There is ongoing research and growing literature describing severe acute respiratory syndrome (SARS-COV-2). There is a growing population of individuals who have recovered from acute SARS-COV-2 infection. The long-term effects of COVID-19 are unknown. There are growing reports of sequelae after acute SARS-CoV-2 not limited to fatigue, dyspnea, reactive airway disease, organizing pneumonia, pulmonary fibrosis, pulmonary hypertension, pulmonary emboli, and tracheal disease. The incidence and natural history of these findings is unstudied.

详细描述

COVID-19 is a leading cause of death worldwide. The long-term effects of the virus are unknown. There is lack of reliable information about the natural history of post acute sequelae. Although there are limited evidence-based treatment guidelines, many patients receive unproven therapies. Given the mortality and morbidity associated with the illness and the growing number of patients who have survived COVID-19 the long-term effects are a growing area of inquiry. This study is designed to better understand the effects of SARS-CoV-2 that develop over time. This study will characterize the recovery process, epidemiology, and natural history of post-acute sequelae. This includes the clinical spectrum of recover and subsets of patients who have symptoms outside the standard course. Factors studied will include the individual, clinical context, severity of disease, duration of symptoms and the impact of treatment for acute SARS-CoV-2. This study will include a breadth of severity from those treated as outpatients, those requiring hospitalization, and those requiring critical care.

Key personnel will extract data recorded in the electronic health record (EHR) as part of routine clinical care in the evaluation in treatment of COVID-19 and its sequelae. Data such as incidence, prevalence, demographics, comorbidities, duration of illness, severity, level of medical care, measures of organ function, drug treatments, laboratory values, pulmonary function tests, computed tomography images, and other data from clinical care will be retrospectively entered into electronic data capture (REDCap).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • COVID-19 diagnosis
  • Seen in a Vanderbilt clinic or affiliated health facility

排除标准

  • 未提供

结局指标

主要结局

Natural history of recovery from COVID-19

时间窗: up to 5 years

Incidence, prevalence, age, sex, BMI, presence of comorbid conditions (including diabetes, hypertension, immunosuppression, or chronic lung disease), duration of illness (in days), level of medical care (intensive care unit, inpatient or outpatient), drug therapies received, pulmonary function tests, and computed tomography images.

次要结局

  • Natural history of patients who do not recover from COVID-19(up to 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Sevin

Principal Investigator

Vanderbilt University Medical Center

研究点 (1)

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