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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04505709
Enrollment
1000
Registered
2020-08-10
Start date
2020-08-01
Completion date
2021-08-01
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

genomics, bioethics, SARS-CoV-2

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.

Interventions

None listed

Sponsors

Hospital Universitario 12 de Octubre
CollaboratorOTHER
Fundacion Investigacion Biomedica Hospital 12 de Octubre
CollaboratorUNKNOWN
Hospital Universitario Fundación Jiménez Díaz
CollaboratorOTHER
Hospital Universitario Infanta Elena
CollaboratorUNKNOWN
Hospital Universitario Virgen de la Arrixaca
CollaboratorOTHER
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
CollaboratorOTHER
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of host genetic markers associated with the evolution of COVID-194 monthsBased 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 crisis10 monthsThrough 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-196 monthsFrom 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026