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

NCT04505709 | Unknown

• 2 other identifiers: STOP-CoronavirusCOV20/00181
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

genomics; bioethics; SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Suspected coronavirus infection without diagnostic confirmation

Sponsors & Collaborators

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

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

SARS-CoV-2

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 10, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

ES (1)