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

Clinical Characteristics and Prognostic Factors of Patients With COVID-19 Using Big Data and Artificial Intelligence Techniques (BigCoviData)

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)

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19 Infection

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.

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

Study Locations

• Spain
  • Guadalajara, Spain
    • Hospital Universitario de Guadalajara
  • Madrid, Spain
    • Hospital Universitario La Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors that predict disease prognosis and outcomes in COVID-19 patients - Hospitalization	All variables and outcomes will be extracted from the free-text narratives available in patients' EHRs Hospitalization; Percentage of hospitalized patients at diagnosis; Percentage of hospitalized patients after diagnosis; Percentage of non-hospitalized patients; Percentage of patients admitted to the ICU Disease outcome: Cure/Hospital Discharge/In-hospital death; Percentage of patients who have been discharged	From 1st Jan 2020
Factors that predict disease prognosis and outcomes in COVID-19 patients - ICU	Transfer to ICU and/or need for medical ventilation; Time (in days) from diagnosis to ICU admission; Time (in days) from the date of first symptom to ICU admission; Time (in days) from hospital admission to ICU admission (in hospitalized patients) Percentage of patients not admitted to the ICU Length of ICU stay; Length of ICU stay (mean duration in days across all patients)	From 1st Jan 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The demographic and clinical characteristics of COVID-19 patients	Gender (% of male patients; % of female patients)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis	Age (in years) at diagnosis	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients -Percentage of patients in each age range	Percentage of patients in each age range (<2; 2-4; 5-14; 15-29; 30-39; 40-49; 50-59; 60-69; 70-79; >= 80).	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients with available PCR (Polymerase Chain Reaction) results	Percentage of patients with available PCR results (Positive; Negative; Unknown) Percentage of patients with available IgG (immunoglobulin G)/IgM (immunoglobulin M) results (Positive; Negative; Unknown) Percentage of patients using Alcohol/Tobacco/Other substances (Yes/No/Former user/Unknown	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patientsTime since first symptom until diagnosis	Time (in days) since first symptom until diagnosis	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination	Physical examination; BMI	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination of patients who are pregnant	Physical examination; Percentage of patients who are pregnant	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination Temperature	Physical examination; Temperature (in degrees Celsius) - Percentage of patients within temperature ranges (in degrees Celsius) (<37, 37-38, >38)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination Heart rate (bmp)	Physical examination; Heart rate (bmp) - Percentage of patients within low/normal/high ranges of heart rate	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin	Physical examination. Laboratory values at diagnosis Hematology: Hemoglobin (g/dl)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin II	Physical examination. Laboratory values at diagnosis Hematology: Hemoglobin n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells	Physical examination. Laboratory values at diagnosis Hematology: Red Blood Cells (106/µl)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells II	Physical examination. Laboratory values at diagnosis Hematology: Red Blood Cells n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils	Physical examination. Laboratory values at diagnosis Hematology: Platelet count (103/mm3) Leukocyte count (103/mm3) Neutrophils (103/mm3) Lymphocytes (103/mm3) Monocytes (103/mm3) Eosinophils (103/mm3) Basophils (103/mm3)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils II	Physical examination. Laboratory values at diagnosis Hematology: Platelet count n(%) Leukocyte count n(%) Neutrophils n(%) Lymphocytes n(%) Monocytes n(%) Eosinophils n(%) Basophils n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR (International Normalized Ratio)	Physical examination. Laboratory values at diagnosis Hematology: INR n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR II	Physical examination. Laboratory values at diagnosis Hematology: INR	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides	Physical examination. Laboratory values at diagnosis Biochemistry: Glucose (mg/dl) Total cholesterol (mg/dl) Triglycerides (mg/dl)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides II	Physical examination. Laboratory values at diagnosis Biochemistry: Glucose n(%) Total cholesterol n(%) Triglycerides n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin	Physical examination. Laboratory values at diagnosis Biochemistry: Total bilirubin (g/dL)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin II	Physical examination. Laboratory values at diagnosis Biochemistry: Total bilirubin n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose	Physical examination. Laboratory values at diagnosis Other values: Creatinine in urine (mg/dl) Glucose in urine (mg/dl)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose II	Physical examination. Laboratory values at diagnosis Other values: Creatinine in urine n(%) Glucose in urine n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Procalcitonin	Physical examination. Laboratory values at diagnosis Other values: Procalcitonin level will be reported" (PCT) ng/mL	From 1st Jan 2020
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)]	Physical examination. Laboratory values at diagnosis Other tests: pH pH n(%) O2 saturation (%) O2 saturation n(%) FIO2 (%) FIO2 n(%) PAFI (%) PAFI n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH	Physical examination. Laboratory values at diagnosis Other tests: pH	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH II	Physical examination. Laboratory values at diagnosis Other tests: PH n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI	Physical examination. Laboratory values at diagnosis Other tests: O2 saturation (%) FIO2 (%) PAFI (%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI II	Physical examination. Laboratory values at diagnosis Other tests: O2 saturation n(%) FIO2 n(%) PAFI n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen)	Physical examination. Laboratory values at diagnosis Other tests: pCO2 (mmHg) pO2 (mmHg)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: pCO2, pO2 II	Physical examination. Laboratory values at diagnosis Other tests: pCO2 n(%) pO2 n(%)	From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients- Comorbidities, Medication, Symptoms	Percentage of patients with family history of selected comorbidities; Percentage of patients with existing selected comorbidities at diagnosis: Cardiovascular disease, Hypertension, Ischemic stroke, Heart Disease (Cardiopathy), etc.; Percentage of patients with medication use/procedures prior to diagnosis. The following medications/treatments will be considered: ACEI (angiotensin converting enzyme inhibitors), ARB (angiotensin receptor blocker), Diuretics, Beta-blocker, etc.; Percentage of patients showing the following signs and symptoms at diagnosis: Cough, Fever, Dyspnoea, Respiratory crackles, Diarrhoea, etc.; Percentage of patients showing the following signs and symptoms after diagnosis: Thromboembolic Disorder, Venous thrombosis, Pulmonary thromboembolism, Upper gastrointestinal bleeding, etc.	From 1st Jan 2020
The patient management (treatment and procedures) in the target population	Percentage of patients assigned to the following procedures after diagnosis: Chest x-ray, Ultrasonography of thorax,Ultrasonography of lung, High resolution computed tomography, Computer tomography of chest, Echocardiogram, EKG Percentage of patients assigned to the following treatments after diagnosis: Oxygen therapy (Oxygen administration by nasal cannula, Oxygen administration by Venturi mask, High concentration oxygen therapy), Prone position, Noninvasive ventilation, Invasive mechanical ventilation,Tracheotomy, Extubation of trachea. Percentage of patients (and mean duration of treatment in days) prescribed with the following pharmacological agents after diagnosis: Lopinavir + Ritonavir, Darunavir + Ritonavir, Darunavir + Cobicistat, IFN (Interferon)- β1b, Chloroquine, Hydroxychloroquine, Antibiotics, Acetylcysteine,Corticosteroids,Selective immunosuppressants, Cyclosporine, Remdesivir, Antithrombotic agents (anticoagulants), Inhibitors of platelet aggregation.	From 1st Jan 2020
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	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; Percentage of patients with selected comorbidities (see complete list above) at diagnosis in each outcome group (ICU-no ICU; hospitalization-no hospitalization; discharge-no discharge; death-no death); Percentage of patients showing selected sings and symptoms (see complete list above) at diagnosis in each outcome group (ICU-no ICU; hospitalization-no hospitalization; discharge-no discharge; death-no death)	From 1st Jan 2020

Collaborators and Investigators

• Sponsor: Savana Research
• Collaborators: Castilla-La Mancha Health Service
• Investigators: Study Chair: José Luis Izquierdo, MD, PhD, Hospital Universitario de Guadalajara; Study Chair: Joan B Soriano, MD, PhD, Hospital Universitario La Princesa; Study Chair: Julio Ancochea, MD, PhD, Hospital Universitario La Princesa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): July 1, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: April 11, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Intensive care unit; Artificial Intelligence; Electronic health record; Machine Learning; Natural language processing; Real-world evidence; SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BigCoviData

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No