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临床试验/NCT04987853
NCT04987853Unknown不适用

Assessment of the Influence of Clinical, Functional, Immunological, and Genetic Factors on the Severity of the Course of Coronavirus Infection With SARS-CoV-2 and Post Covid Syndrome

National Research Center for Cardiac Surgery, Kazakhstan1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年6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
300
试验地点
1
主要终点
bioinformatic data analysis

研究概览

简要总结

The purpose of the program. To determine the clinical, functional, immunological, and genetic factors affecting the severity of the course of acute coronavirus infection COVID-19 and PostCovid syndrome, in order to develop management tactics for such patients to reduce the risk of complications and disability.

详细描述

Objectives of the program:

  1. To determine the clinical and functional characteristics of patients with varying degrees of the course of the acute phase of COVID-19 and Post Covid syndrome.

1.1. To study the features of neurological disorders in patients with varying degrees of the course of the acute phase of COVID-19 and Post Covid syndrome. 2. To study the immunological profile of patients with varying degrees of the course of the acute phase of COVID-19 and Post Covid syndrome. 3. To study the genetic profile of patients with varying degrees of the course of the acute phase of COVID-19 and Post Covid syndrome. 4. Identify potential predictors of COVID-19 severity. 5. To determine the markers that allows predicting the development of the Post Covid syndrome. 6. Based on the selected markers, develop a COVID-19 outcome scale to determine the tactics of patient management to prevent the development of Post Covid syndrome.

The study will include patients with a positive PCR test for COVID-19. Patients in the acute phase of the course of the disease are monitored and treated in accordance with the republican COVID-19 treatment protocol. After signing the informed consent, the patient will be included in the study. The collection of the necessary materials for subsequent analyzes (clinical-functional, genetic, immunological) will be carried out in accordance with this protocol. Subsequently, patients are observed within one year from the moment of illness in accordance with the study protocol and with the collection of all necessary materials.

Clinical and functional analysis:

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18 years old
  • Patients with a history of coronavirus infection COVID-19 confirmed by PCR analysis
  • Patients who signed informed consent to participate in the study

排除标准

  • Refusal to undergo diagnostic procedures determined by the research protocol.
  • Evidence for preexisting interstitial lung disease.
  • Participation in another study.

结局指标

主要结局

bioinformatic data analysis

时间窗: 24 months

To analyze a large number of genetic markers, it is planned to carry out genome-wide sequencing followed by analysis of genetic polymorphisms of candidate genes encoding coronavirus receptors and immunological factors

the level of the immune response

时间窗: 24 months

Calculation of the level of CD4 +, CD8 + and NK cells. The level of antibodies of the IgG and IgM classes to the proteins of the coronavirus S1, RBD and N was determined

次要结局

未报告次要终点

研究者

发起方
National Research Center for Cardiac Surgery, Kazakhstan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Makhabbat Bekbossynova

Chairman of the Board

National Research Center for Cardiac Surgery, Kazakhstan

研究点 (1)

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