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

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Fundación Jiménez Díaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with confirmed diagnosis of COVID-19 (positive RT-PCR for SARS-CoV-2 in respiratory sample) will from the following university hospitals, will be enrolled for the study:

Hospital Universitario 12 de Octubre, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Infanta Elena, Hospital Clínico Universtario Virgen de la Arrixaca

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of host genetic markers associated with the evolution of COVID-19	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	4 months
Analysis of bioethical aspects related to in-hospital management of the health crisis	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	10 months
Analysis of the spectrum of mutants of SARS-CoV-2 and its possible association with the clinical evolution of COVID-19	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	6 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Collaborators: Hospital Universitario Virgen de la Arrixaca; Hospital Universitario 12 de Octubre; Hospital Universitario Fundación Jiménez Díaz; Fundacion Investigacion Biomedica Hospital 12 de Octubre; Hospital Universitario Infanta Elena; Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; genomics; bioethics
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: STOP-Coronavirus; COV20/00181 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No