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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04505709
• Other study ID #: STOP-Coronavirus
• Secondary ID: COV20/00181
• Status: Enrolling by invitation
• Start date: August 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2020
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Diaz	Madrid

Sponsors (7)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Fundacion Investigacion Biomedica Hospital 12 de Octubre, Hospital Universitario 12 de Octubre, Hospital Universitario Fundacion Jimenez Diaz, Hospital Universitario Infanta Elena, Hospital Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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