Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-02 @ 6:07 AM
Study NCT ID:
NCT04569851
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2020-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Prognostic Factors of Patients With COVID-19 (Coronavirus Disease 2019)
Sponsor:
Savana Research
Organization:
Study Overview
Official Title:
Clinical Characteristics and Prognostic Factors of Patients With COVID-19 Using Big Data and Artificial Intelligence Techniques (BigCoviData)
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: