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.
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
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.
- Conditions
- COVID-19 Infection
- 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.
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
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)
The demographic and clinical characteristics of COVID-19 patients
Gender (% of male patients; % of female patients)
Measured: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis
Age (in years) at diagnosis
Measured: 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).
Measured: 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
Measured: 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
Measured: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination
Physical examination
- BMI
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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(%)
Measured: 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)
Measured: 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(%)
Measured: 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)
Measured: 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(%)
Measured: 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(%)
Measured: 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
Measured: 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)
Measured: 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(%)
Measured: 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)
Measured: 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(%)
Measured: 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)
Measured: 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(%)
Measured: 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
Measured: 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(%)
Measured: 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
Measured: 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(%)
Measured: 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 (%)
Measured: 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(%)
Measured: 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)
Measured: 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(%)
Measured: 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.
Measured: 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.
Measured: 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)
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.
- First posted30 Sep 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2023
- Study completion28 Feb 2024
Why it stopped: The study had to be terminated due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Savana Research
- Sponsor type
- Research network
- Collaborators
- Castilla-La Mancha Health Service
- Responsible party
- Sponsor
- Investigators
- José Luis Izquierdo, MD, PhD, Study chair, University of GuadalajaraJoan B Soriano, MD, PhD, Study chair, Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaJulio Ancochea, MD, PhD, Study chair, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Prognostic Factors of Patients With COVID-19 Using Big Data and Artificial Intelligence Techniques (BigCoviData)
- ClinicalTrials.gov ID
- NCT04569851
- Acronym / sponsor ID
- BigCoviData
- Conditions
- COVID-19 Infection
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study had to be terminated due to lack of funding
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Savana ResearchResearch network
- Collaborators
- Castilla-La Mancha Health Service
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- All patients with suspected COVID-19 infection, as captured in the patients' EHRs of the participating sites.
Key exclusion criteria (1 listed)
- Not suspected COVID-10 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors that predict disease prognosis and outcomes in COVID-19 patients - Hospitalization
Time frame: 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
Time frame: 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)
34 secondary outcomes
The demographic and clinical characteristics of COVID-19 patients
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients-Age at diagnosis
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients -Percentage of patients in each age range
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients with available PCR (Polymerase Chain Reaction) results
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patientsTime since first symptom until diagnosis
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination of patients who are pregnant
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination Temperature
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Physical examination Heart rate (bmp)
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Hemoglobin II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology, Red Blood Cells II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology: Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR (International Normalized Ratio)
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Hematology- INR II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Glucose, Cholesterol, Triglycerides II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Biochemistry: Bilirubin II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Creatinine, Glucose II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other Values: Procalcitonin
Time frame: 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)]
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: PH II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: O2 saturation, FIO2, PAFI II
Time frame: 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)
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients - Laboratory values: Other test: pCO2, pO2 II
Time frame: From 1st Jan 2020
The demographic and clinical characteristics of COVID-19 patients- Comorbidities, Medication, Symptoms
Time frame: From 1st Jan 2020
The patient management (treatment and procedures) in the target population
Time frame: 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
Time frame: From 1st Jan 2020
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Luis Izquierdo, MD, PhD study chair
University of Guadalajara
Joan B Soriano, MD, PhD study chair
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Julio Ancochea, MD, PhD study chair
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
2 sites in 1 country: see every site and its status.
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.