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COVID-19 InfectionNCT04569851

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

An observational study of COVID-19 Infection, run by Savana Research at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID-19 Infection
How many people
100,000 participants
Where
2 sitesSpain
Study dates
1 Jan 2020to 28 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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: * Confirmed positive cases (i.e., all patients who tested positive for COVID-19 ). * Confirmed negative cases (i.e., all patients who tested negative for COVID-19) * Possible cases (i.e., all patients with suspected COVID-19 but no/pending test results) To determine the characteristics of the patients according to their clinical outcome, we will study both the confirmed positive cases and all possible classes (with no/pending laboratory results) subpopulations

Who may be able to join

  • All patients with suspected COVID-19 infection, as captured in the patients' EHRs of the participating sites.

Who cannot join

  • Not suspected COVID-10 infection

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • Hospital Universitario de Guadalajara

    Guadalajara, Guadalajara

  • Hospital Universitario La Princesa

    Madrid, Madrid

Other trials in Spain

About this study

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

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)

Read the 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.
Keywords
Artificial Intelligence, Electronic health record, Intensive care unit, Natural language processing, Machine Learning, Real-world evidence, SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2), COVID-19
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From 1st Jan 2020

  2. 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)

    Measured: From 1st Jan 2020

Secondary outcomes (34)
  1. The demographic and clinical characteristics of COVID-19 patients

    Gender (% of male patients; % of female patients)

    Measured: From 1st Jan 2020

  2. The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis

    Age (in years) at diagnosis

    Measured: From 1st Jan 2020

  3. 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).

    Measured: From 1st Jan 2020

  4. 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

    Measured: From 1st Jan 2020

  5. The demographic and clinical characteristics of COVID-19 patientsTime since first symptom until diagnosis

    Time (in days) since first symptom until diagnosis

    Measured: From 1st Jan 2020

  6. The demographic and clinical characteristics of COVID-19 patients - Physical examination

    Physical examination

    • BMI

    Measured: From 1st Jan 2020

  7. The demographic and clinical characteristics of COVID-19 patients - Physical examination of patients who are pregnant

    Physical examination

    • Percentage of patients who are pregnant

    Measured: From 1st Jan 2020

  8. 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)

    Measured: From 1st Jan 2020

  9. 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

    Measured: From 1st Jan 2020

  10. The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin

    Physical examination. Laboratory values at diagnosis

    Hematology:

    Hemoglobin (g/dl)

    Measured: From 1st Jan 2020

  11. The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin II

    Physical examination. Laboratory values at diagnosis

    Hematology:

    Hemoglobin n(%)

    Measured: From 1st Jan 2020

  12. 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)

    Measured: From 1st Jan 2020

  13. 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(%)

    Measured: From 1st Jan 2020

  14. 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)

    Measured: From 1st Jan 2020

  15. 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(%)

    Measured: From 1st Jan 2020

  16. 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(%)

    Measured: From 1st Jan 2020

  17. The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR II

    Physical examination. Laboratory values at diagnosis

    Hematology:

    INR

    Measured: From 1st Jan 2020

  18. 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)

    Measured: From 1st Jan 2020

  19. 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(%)

    Measured: From 1st Jan 2020

  20. The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin

    Physical examination. Laboratory values at diagnosis

    Biochemistry:

    Total bilirubin (g/dL)

    Measured: From 1st Jan 2020

  21. The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin II

    Physical examination. Laboratory values at diagnosis

    Biochemistry:

    Total bilirubin n(%)

    Measured: From 1st Jan 2020

  22. 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)

    Measured: From 1st Jan 2020

  23. 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(%)

    Measured: From 1st Jan 2020

  24. 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

    Measured: From 1st Jan 2020

  25. 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(%)

    Measured: From 1st Jan 2020

  26. The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH

    Physical examination. Laboratory values at diagnosis

    Other tests:

    pH

    Measured: From 1st Jan 2020

  27. 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(%)

    Measured: From 1st Jan 2020

  28. 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 (%)

    Measured: From 1st Jan 2020

  29. 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(%)

    Measured: From 1st Jan 2020

  30. 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)

    Measured: From 1st Jan 2020

  31. 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(%)

    Measured: From 1st Jan 2020

  32. 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.

    Measured: From 1st Jan 2020

  33. 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.

    Measured: From 1st Jan 2020

  34. 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)

    Measured: From 1st Jan 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start1 Jan 2020
  3. Primary completion1 Jul 2023
  4. Study completion28 Feb 2024

Why it stopped: The study had to be terminated due to lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
100,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04569851
Sponsor's protocol ID
BigCoviData
Status last verified
Nov 2024
First submitted
11 Apr 2020
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Infection, run by Savana Research at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study had to be terminated due to lack of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Factors that predict disease prognosis and outcomes in COVID-19 patients - Hospitalization (time frame: From 1st Jan 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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