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

• Conditions: Covid19

• Registration Number: NCT04505709
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-01
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Study First Posted: 2020-08-10
• Last Update Posted: 2020-08-10
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• Suspected coronavirus infection without diagnostic confirmation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain