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Clinical Characteristics and Prognostic Factors of Patients With COVID-19 (Coronavirus Disease 2019)

NCT ID: NCT04569851

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-02-28

Brief Summary

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This is a multicenter, non-interventional, retrospective study using data captured in the EHRs (Electronic Health Records) of the participating hospital sites to determine factors that predict disease prognosis and outcomes in COVID-19 patients, specifically: Hospitalization/Off-site monitoring, transfer to ICU and/or need for medical mechanical ventilation (both invasive and non- invasive), length of ICU stay, and outcome (cure/ hospital discharge, in-hospital death)

Detailed Description

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Data captured in the EHRs will be collected from all available departments, including inpatient hospital, outpatient hospital, emergency room, etc. for virtually all types of provided services in each participating site. The study period will be from January 1, 2020 to the most recent data available.

* Primary objective To determine factors that predict disease prognosis and outcomes in COVID-19 patients, specifically: Hospitalization/Off-site monitoring, transfer to ICU and/or need for medical mechanical ventilation (both invasive and non- invasive), length of ICU stay, and outcome (cure/ hospital discharge, in-hospital death)
* Secondary objectives

* To describe the demographic and clinical characteristics of COVID-19 patients
* To describe the patient management (treatment and procedures) in the target population
* To describe the outcomes of COVID-19 (discharge, hospitalization, transfer to ICU/ mechanical medical ventilation, in-hospital death) in relation to patients' clinical and demographic characteristics, and treatment received
* To determine whether the factors that predict COVID-19 prognosis and outcome also apply to other types of pneumonia.
* Exploratory objectives One of the goals of this study is to configure the Big Data system to unravel any hidden variable/s (and their associations) that may offer novel clinical insights into COVID-19 management.

Conditions

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COVID-19 Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All patients with suspected COVID-19 infection, as captured in the patients' EHRs of the participating sites.

Exclusion Criteria

* Not suspected COVID-10 infection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Castilla-La Mancha Health Service

OTHER

Sponsor Role collaborator

Savana Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Luis Izquierdo, MD, PhD

Role: STUDY_CHAIR

Hospital Universitario de Guadalajara

Joan B Soriano, MD, PhD

Role: STUDY_CHAIR

Hospital Universitario La Princesa

Julio Ancochea, MD, PhD

Role: STUDY_CHAIR

Hospital Universitario La Princesa

Locations

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Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status

Hospital Universitario La Princesa

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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BigCoviData

Identifier Type: -

Identifier Source: org_study_id