Clinical trial NCT04505709: Clinical, Immunological, Genomic, Virological and Bioethical Actors of COVID-19
Official title: STOP-Coronavirus: Clinical, Immunological, Genomic, Virological and Bioethical Actors of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: genomics
bioethics
SARS-CoV-2
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
name: Fundacion Investigacion Biomedica Hospital 12 de Octubre
name: Hospital Universitario Fundación Jiménez Díaz
name: Hospital Universitario Infanta Elena
name: Hospital Universitario Virgen de la Arrixaca
name: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
First posted: 2020-08-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of host genetic markers associated with the evolution of COVID-19
timeFrame: 4 months
measure: Analysis of bioethical aspects related to in-hospital management of the health crisis
timeFrame: 10 months
measure: Analysis of the spectrum of mutants of SARS-CoV-2 and its possible association with the clinical evolution of COVID-19
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
References: