Clinical trial NCT04569851: Clinical Characteristics and Prognostic Factors of Patients With COVID-19 (Coronavirus Disease 2019)
Official title: Clinical Characteristics and Prognostic Factors of Patients With COVID-19 Using Big Data and Artificial Intelligence Techniques (BigCoviData)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Infection
Keywords: Artificial Intelligence
Electronic health record
Intensive care unit
Natural language processing
Machine Learning
Real-world evidence
SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2)
COVID-19
Lead sponsor: Savana Research
Sponsor class: NETWORK
Collaborators: name: Castilla-La Mancha Health Service
First posted: 2020-09-30
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of all patients with suspected COVID-19 infection, as captured in the patients' EHRs of the participating sites.

Among the suspected COVID-19 cases, we will determine the following:

* Confirmed positive cases (i.e., all patients who tested positive for COVID-19 ).
* Confirmed negative cases (i.e., all patients who tested negative for COVID-19)
* Possible cases (i.e., all patients with suspected COVID-19 but no/pending test results) To determine the characteristics of the patients according to their clinical outcome, we will study both the confirmed positive cases and all possible classes (with no/pending laboratory results) subpopulations

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.

Eligibility criteria: 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

Primary outcomes:
measure: Factors that predict disease prognosis and outcomes in COVID-19 patients - Hospitalization
timeFrame: From 1st Jan 2020
measure: Factors that predict disease prognosis and outcomes in COVID-19 patients - ICU
timeFrame: From 1st Jan 2020
Secondary outcomes:
measure: The demographic and clinical characteristics of COVID-19 patients
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients -Percentage of patients in each age range
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients with available PCR (Polymerase Chain Reaction) results
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patientsTime since first symptom until diagnosis
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Physical examination
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Physical examination of patients who are pregnant
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Physical examination Temperature
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Physical examination Heart rate (bmp)
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR (International Normalized Ratio)
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Procalcitonin
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH (Potential Hydrogen), O2 Saturation, FIO2 (Fractional Inspired Oxigen), PAFI [Blood pressure of oxygen / inspired fraction of oxygen (PaO2/FiO2)]
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen)
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: pCO2, pO2 II
timeFrame: From 1st Jan 2020
measure: The demographic and clinical characteristics of COVID-19 patients- Comorbidities, Medication, Symptoms
timeFrame: From 1st Jan 2020
measure: The patient management (treatment and procedures) in the target population
timeFrame: From 1st Jan 2020
measure: The outcomes of COVID-19 (discharge, hospitalization, transfer to ICU/ mechanical medical ventilation, in-hospital death) in correlation to patients' clinical and demographic characteristics, and treatment received
timeFrame: From 1st Jan 2020
Other outcomes:
Locations:
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
Study officials:
affiliation: Hospital Universitario de Guadalajara
name: José Luis Izquierdo, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Princesa
name: Joan B Soriano, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Princesa
name: Julio Ancochea, MD, PhD
role: STUDY_CHAIR
References: