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

Active, not recruiting

• Conditions: COVID-19 Infection

• Registration Number: NCT04569851
• Lead Sponsor: Savana Research

Brief Summary

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

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-04-11
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-09-30
• Primary Completion: 2023-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Factors that predict disease prognosis and outcomes in COVID-19 patients - Hospitalization	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	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)

Secondary Outcome Measures

Name	Time	Method
The demographic and clinical characteristics of COVID-19 patients -Percentage of patients in each age range	From 1st Jan 2020	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).
The demographic and clinical characteristics of COVID-19 patientsTime since first symptom until diagnosis	From 1st Jan 2020	Time (in days) since first symptom until diagnosis
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR (International Normalized Ratio)	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Hematology: INR n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Hematology: INR
The demographic and clinical characteristics of COVID-19 patients - Physical examination	From 1st Jan 2020	Physical examination; * BMI
The demographic and clinical characteristics of COVID-19 patients - Physical examination of patients who are pregnant	From 1st Jan 2020	Physical examination; * Percentage of patients who are pregnant
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Hematology: Hemoglobin n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Hematology: Red Blood Cells (106/µl)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Hematology: Red Blood Cells n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils	From 1st Jan 2020	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)
The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis	From 1st Jan 2020	Age (in years) at diagnosis
The demographic and clinical characteristics of COVID-19 patients with available PCR (Polymerase Chain Reaction) results	From 1st Jan 2020	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
The demographic and clinical characteristics of COVID-19 patients - Physical examination Heart rate (bmp)	From 1st Jan 2020	Physical examination; * Heart rate (bmp) - Percentage of patients within low/normal/high ranges of heart rate
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Hematology: Hemoglobin (g/dl)
The demographic and clinical characteristics of COVID-19 patients - Physical examination Temperature	From 1st Jan 2020	Physical examination; * Temperature (in degrees Celsius) - Percentage of patients within temperature ranges (in degrees Celsius) (\<37, 37-38, \>38)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Biochemistry: Glucose (mg/dl) Total cholesterol (mg/dl) Triglycerides (mg/dl)
The demographic and clinical characteristics of COVID-19 patients	From 1st Jan 2020	Gender (% of male patients; % of female patients)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Biochemistry: Total bilirubin n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Other values: Creatinine in urine (mg/dl) Glucose in urine (mg/dl)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Other tests: PH n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: pCO2, pO2 II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Other tests: pCO2 n(%) pO2 n(%)
The patient management (treatment and procedures) in the target population	From 1st Jan 2020	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.
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Hematology: Platelet count n(%) Leukocyte count n(%) Neutrophils n(%) Lymphocytes n(%) Monocytes n(%) Eosinophils n(%) Basophils n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Procalcitonin	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Other values: Procalcitonin level will be reported" (PCT) ng/mL
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	Physical examination. Laboratory values at diagnosis; Other tests: pH pH n(%) O2 saturation (%) O2 saturation n(%) FIO2 (%) FIO2 n(%) PAFI (%) PAFI n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Other tests: O2 saturation (%) FIO2 (%) PAFI (%)
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	Physical examination. Laboratory values at diagnosis; Other tests: pCO2 (mmHg) pO2 (mmHg)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Biochemistry: Glucose n(%) Total cholesterol n(%) Triglycerides n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Biochemistry: Total bilirubin (g/dL)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Other values: Creatinine in urine n(%) Glucose in urine n(%)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI II	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Other tests: O2 saturation n(%) FIO2 n(%) PAFI n(%)
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 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)
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH	From 1st Jan 2020	Physical examination. Laboratory values at diagnosis; Other tests: pH
The demographic and clinical characteristics of COVID-19 patients- Comorbidities, Medication, Symptoms	From 1st Jan 2020	* 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.

Trial Locations

Locations (2)

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain