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临床试验/NCT04799444
NCT04799444Unknown不适用

Complications Post COVID-19 - Observational Study in Children and Adults

Polish Mother Memorial Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Number of participants with severe post-COVID-19 complications

研究概览

简要总结

All consecutive patients admitted to the Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland between 1st October 2020 and 31st December 2021 due to symptoms, which might reflect complications following COVID-19, will be included in the observational cohort study. Data concerning clinical characteristics, results of laboratory tests, other studies, such as: echocardiography, 24 hours ambulatory ECG recording will be collected. The study is planned also to be extended with the genetic predisposition in children to COVID-19 late complications (within independent grant).

详细描述

A wide range of complications have been linked to COVID-19 - the coronavirus disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is well known that COVID-19 affects multiple organs. Most of the data however present the early complications during the acute phase of the infection, and there is still a lack of knowledge on the late complications that might appear after recovery. Additionally, the long-term complications in patients who were asymptomatic or had mild symptoms during the acute phase of infection, not requiring hospitalization, oxygen therapy or mechanical ventilation has not been fully studied. Therefore, our aim was to assess factors related to the severity of post-COVID complications among patients without severe symptoms in the acute phase of COVID-19. The study will include consecutive COVID-19 convalescents (the infection of coronavirus was confirmed with real-time polymerase chain reaction test or positive result of autoantibodies) admitted to the Departments of Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland, for complications. Both children and adults will be included in the study. The patients will have laboratory testing and other studies due to the character of symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • consecutive COVID-19 convalescents (the infection of coronavirus was confirmed with real-time polymerase chain reaction test or positive result of autoantibodies) admitted to the Departments of Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland, for complications

排除标准

  • no history of COVID-19 infection,
  • lack of complications post COVID-19,
  • severe course of Sars-COV-2 infection,
  • lack pf patient's agreement to be included in the study

结局指标

主要结局

Number of participants with severe post-COVID-19 complications

时间窗: Baseline

Data concerning clinical characteristics, results of laboratory tests, other studies, such as: echocardiography, 24 hours ambulatory ECG recording will be collected. According to the results patients will be qualified to severe or mild complication group

Factors related to the severity of post-COVID-19 complications

时间窗: Baseline

Data concerning clinical characteristics, results of laboratory tests, other studies, such as: echocardiography, 24 hours ambulatory ECG recording will be collected to verify which of them can be related to the severity of post-COVID-19 complications.

次要结局

未报告次要终点

研究者

发起方
Polish Mother Memorial Hospital Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maciej Banach

MD,PhD,FNLA,FAHA,FESC,FASA

Polish Mother Memorial Hospital Research Institute

研究点 (1)

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