Clinical Characteristics and Prognostic Factors of Patients With COVID-19 Using Big Data and Artificial Intelligence Techniques (BigCoviData)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100,000
- 试验地点
- 2
- 主要终点
- Factors that predict disease prognosis and outcomes in COVID-19 patients - Hospitalization
研究概览
简要总结
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)
详细描述
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.
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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)
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Secondary objectives
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To describe the demographic and clinical characteristics of COVID-19 patients
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To describe the patient management (treatment and procedures) in the target population
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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
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To determine whether the factors that predict COVID-19 prognosis and outcome also apply to other types of pneumonia.
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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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with suspected COVID-19 infection, as captured in the patients' EHRs of the participating sites.
排除标准
- •Not suspected COVID-10 infection
结局指标
主要结局
Factors that predict disease prognosis and outcomes in COVID-19 patients - Hospitalization
时间窗: From 1st Jan 2020
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
Factors that predict disease prognosis and outcomes in COVID-19 patients - ICU
时间窗: From 1st Jan 2020
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)
次要结局
- The demographic and clinical characteristics of COVID-19 patients -Percentage of patients in each age range(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patientsTime since first symptom until diagnosis(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR (International Normalized Ratio)(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR II(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Physical examination(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Physical examination of patients who are pregnant(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin II(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells II(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients with available PCR (Polymerase Chain Reaction) results(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Physical examination Heart rate (bmp)(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Physical examination Temperature(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin II(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH II(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: pCO2, pO2 II(From 1st Jan 2020)
- The patient management (treatment and procedures) in the target population(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils II(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Procalcitonin(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)](From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI(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)(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides II(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose II(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI II(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(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH(From 1st Jan 2020)
- The demographic and clinical characteristics of COVID-19 patients- Comorbidities, Medication, Symptoms(From 1st Jan 2020)