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临床试验/NCT04505709
NCT04505709Unknown不适用

STOP-Coronavirus: Clinical, Immunological, Genomic, Virological and Bioethical Actors of COVID-19

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年8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
1,000
试验地点
1
主要终点
Identification of host genetic markers associated with the evolution of COVID-19

研究概览

简要总结

The STOP-Coronavirus project is an integrated and multidisciplinary study that aims to analyze the impact that various factors have on the evolution and prognosis of the current COVID-19. Clinical presentation, immunological markers, therapeutic strategies, host and virus genomics, and bioethical considerations will be analyzed with a prospective multicenter cohort of patients with a diagnosis of COVID-19.

详细描述

This project led my Dr Aguado Garcia, has established 8 Work Parckages (WP) to analyze factors involved in the impact of COVID-19. WP that correspond to University Hospital Fundacion Jimenez Diaz are described in this register across different objectives:

WP 3 (Dr Ayuso García) is aimed to analyze the genetic markers of host susceptibility associated with clinical evolution of COVID-19.

WP 6 (Dr Ruiz Hornillos) will study the socio-economic and bioethical repercussions of COVID-19.

WP 7 (Dr Perales) will analyze the complexity of the spectrum of SARS-CoV-2 mutants and their possible association with the evolutionary course of COVID-19

This project will guide and individualize the clinical and therapeutic approach to COVID-19 and mitigate the health and social impact of the pandemic.

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 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of COVID-19 (positive RT-PCR for SARS-CoV-2 in respiratory sample).

排除标准

  • Suspected coronavirus infection without diagnostic confirmation

结局指标

主要结局

Identification of host genetic markers associated with the evolution of COVID-19

时间窗: 4 months

Based on the cohort of patients with a confirmed diagnosis of COVID-19 and according to severity categories, a Genome-wide association study (GWAS) will be carried out

Analysis of bioethical aspects related to in-hospital management of the health crisis

时间窗: 10 months

Through structured interviews, data collection in each epidemiological period, and evaluation of the application of recommended measures from the bioethical point of view, a comparative study will be carried out between hospitals, taking into account the use of resources and analyzing the situations of ethical commitment for healthcare professionals, patients and institutions

Analysis of the spectrum of mutants of SARS-CoV-2 and its possible association with the clinical evolution of COVID-19

时间窗: 6 months

From the mass sequencing of SARS-CoV-2 and the calculation of viral variability indices, it will be studied whether or not there is an association between the spectrum of viral mutants and clinical evolution

次要结局

未报告次要终点

研究者

发起方
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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