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The study had to be terminated due to lack of funding
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| Name | Class |
|---|---|
| Castilla-La Mancha Health Service | OTHER |
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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)
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
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.
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| 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
| 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
| From 1st Jan 2020 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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:
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| Name | Affiliation | Role |
|---|---|---|
| José Luis Izquierdo, MD, PhD | University of Guadalajara | Study Chair |
| Joan B Soriano, MD, PhD | Hospital Universitario La Princesa | Study Chair |
| Julio Ancochea, MD, PhD | Hospital Universitario La Princesa | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Guadalajara | Guadalajara | Guadalajara | Spain | |||
| Hospital Universitario La Princesa |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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
| From 1st Jan 2020 |
| The demographic and clinical characteristics of COVID-19 patients - Physical examination of patients who are pregnant | Physical examination
| From 1st Jan 2020 |
| The demographic and clinical characteristics of COVID-19 patients - Physical examination Temperature | Physical examination
| From 1st Jan 2020 |
| The demographic and clinical characteristics of COVID-19 patients - Physical examination Heart rate (bmp) | Physical examination
| 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 |
| 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
| From 1st Jan 2020 |
| Madrid |
| Madrid |
| Spain |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |