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

Study Overview
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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.

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

Conditions
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COVID-19 Infection

Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care unit, Artificial Intelligence, Electronic health record, Natural language processing, Machine Learning, Real-world evidence, SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2), COVID-19