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)
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
100,000
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Universitario La Princesa
Madrid, Spain
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
Time frame: 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)
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients
Gender (% of male patients; % of female patients)
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis
Age (in years) at diagnosis
Time frame: 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).
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients with available PCR (Polymerase Chain Reaction) results
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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
Time frame: 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
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination
Physical examination * BMI
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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(%)
Time frame: 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)
Time frame: 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(%)
Time frame: 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)
Time frame: 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(%)
Time frame: 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(%)
Time frame: 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
Time frame: 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)
Time frame: 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(%)
Time frame: 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)
Time frame: 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(%)
Time frame: 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)
Time frame: 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(%)
Time frame: 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
Time frame: 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(%)
Time frame: 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
Time frame: 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(%)
Time frame: 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 (%)
Time frame: 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(%)
Time frame: 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)
Time frame: 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(%)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: From 1st Jan 2020