Coronavirus Disease 2019COVIXTREMNCT04724850
Evolution of Coronavirus Disease 2019 (COVID-19) Patients in Extremadura
An observational study of Coronavirus Disease 2019, run by Juan Fernando Masa Jiménez at 1 site in Spain.
Trial summary
At the end of January 2020, the international community was informed of the presence of a new viral disease that started in Wuhan (China) and spread rapidly throughout the world. The identified virus belonged to the coronavirus family (SARS-CoV-2) and the disease was named COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus Disease 2019
- How many people
- 440 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jul 2020to 30 Dec 2022
- 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: Patients diagnosed with SARS-Cov2 infection according to the clinical and microbiological criteria established by the Health Authorities and clinical practice in the community of Extremadura in Spain, and who require or not hospitalization and who receive or not specific pharmacologic treatment for the SARS-Cov2 infection.
Who may be able to join
- Patients of any age and sex, including minors and pregnant women.
- Patients diagnosed with SARS-Cov2 infection according to the clinical and microbiological criteria established by the Health Authorities and clinical practice (these can be modified based on the Technical document "Clinical management of COVID-19" of the Ministry of Health) who require or not hospitalization and who receive or not specific pharmacologic treatment for the SARS-Cov2 infection.
Who cannot join
- Patients who do not give their informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study About the Characteristics and Evolution of Patients Diagnosed With COVID-19 in Extremadura
At the end of January 2020, the international community was informed of the presence of a new viral disease that started in Wuhan (China) and spread rapidly throughout the world. The identified virus belonged to the coronavirus family (SARS-CoV-2) and the disease was named COVID-19. Today there are more than 2 million people diagnosed in Spain and more than 40 thousand in Extremadura. The partial knowledge about the development, evolution of the affected citizenship and their prognosis both early and late makes it necessary to analyze in depth their global and particular characteristics.
We will carry out a multicenter, observational, descriptive, cross-sectional and longitudinal study of patients diagnosed with SARS-CoV-2 virus infection in the Community of Extremadura to determine the effectiveness of drug treatments and the clinical and evolutionary characteristics of these patients and the different factors that may influence its evolution.
Read the detailed description
Epidemiological, socio-sanitary, clinical, analytical and radiological data will be collected retrospectively and prospectively from all patients diagnosed with COVID-19 without hospital admission in our community from the start of the pandemic and for one year from the start of the study.
These data will be obtained mainly from the clinical history and collected in the data collection notebooks and electronic base designed for the study for subsequent analysis. The data collection period will be one year, estimating a sample of 5,000 patients.
In addition, patients included in the study prospectively will be asked for consent to collect a blood sample for freezing and storage in the Biobank of Extremadura and subsequent use to determine biomarkers and genetics.
The present study will be carried out in accordance with the observational National Post-Authorization Study (EPA) for medicines for human use proposed by Valdecilla Health Research Institute (IDIVAL), the main objective of which is to determine the effectiveness of the pharmacological treatments currently used in COVID-19.
- Conditions
- Coronavirus Disease 2019
- Keywords
- Patients diagnosed with coronavirus disease 2019, Clinical characteristics of coronavirus disease 2019, Clinical evolution of coronavirus disease 2019, Effectiveness of drug treatment for coronavirus disease 2019
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | All patients diagnosed with COVID-19 in the community of Extremadura from the beginning of the epidemic to its ending in Spain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of the pharmacological treatments used for hospitalized patients with COVID-19 in clinical practice assessed in terms of mortality.
To determine the effectiveness of each drug the investigators will use the percentage of deceased subjects who were treated with each one of them.
Measured: 28 days
To determine the effectiveness of the pharmacological treatments used in the clinical practice for hospitalized patients with SARS-Cov2 infection assessed by time until death.
To determine the effectiveness of each drug the investigators will use the time in days from the start to the pharmacological treatment to death.
Measured: 28 days
To determine the effectiveness of the pharmacological treatments used in the clinical practice for hospitalized patients with SARS-Cov2 infection assessed in terms of recovery.
To determine the effectiveness of each drug the investigators will use the time from the start of the pharmacological treatment to recovery, understanding as recovery the disappearance of symptoms and two negative reverse transcription polymerase chain reaction (PCR) separated by at least 24 hours.
Measured: 28 days
Secondary outcomes (53)
To evaluate the influence of the age on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the age in years of the hospitalized patients on the effectiveness of the pharmacological treatments assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of the gender on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the gender (male or female) of the hospitalized patients on the effectiveness of the pharmacological treatments assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of the arterial hypertension on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of arterial hypertension (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of the diabetes on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
We will analyze the effect of the presence of diabetes (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of the dyslipidemia on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of dyslipidemia (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of myocardial infarction on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of myocardial infarction (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of angina on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of angina (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of chronic heart disease on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of chronic heart failure (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of peripheral arterial disease the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of peripheral arterial disease (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of ictus on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of ictus (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To influence of dementia on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of dementia (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of neuromuscular disease on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of neuromuscular disease (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of chronic obstructive pulmonary disease on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of chronic obstructive pulmonary disease (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of asthma the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of asthma (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate de influence of chronic kidney disease the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
The investigators will analyze the effect of the presence of a history of chronic kidney disease (yes or not) on the effectiveness of the pharmacological treatments in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of the severity of the disease on the effectiveness of the pharmacologic treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice assessed in terms of mortality.
To determine the severity of the disease, the investigators will use the following severity classification:
Uncomplicated disease (symptoms of the upper respiratory tract with or without nonspecific symptoms: fever, muscle pain or atypical symptoms in the elderly), mild pneumonia (pneumonia confirmed on chest radiography and without signs of severity, with room air oxygen saturation > 90% and CURB65 score* ≤ 1), severe pneumonia (failure of > 1 organ or air ambient oxygen saturation < 90% or respiratory rate ≥ 30 rpm), respiratory distress (clinical findings, bilateral infiltrates on chest radiography and oxygenation deficit with PaO2 / FiO2 ≤ 300 mmHg), sepsis (organic dysfunction that can be identified as an acute change in the SOFA score > 2 points) and septic shock (arterial hypotension that persists after administration of resuscitation volume and that requires vasopressors to maintain a mean arterial pressure ≥ 65 mmHg and lactate ≥ 2 mmol / L in the absence of hypovolemia).
Measured: 28 days
To evaluate the influence of taking non-steroidal anti-inflammatory drugs on the effectiveness of the pharmacological treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice.
The investigators will analyze the effect of usual taking non-steroidal anti-inflammatory drugs (yes or not) on the effectiveness of the pharmacological treatments for SARS-Cov2 in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of taking angiotensin II receptor antagonists on the effectiveness of the pharmacological treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice.
The investigators will analyze the effect of usual taking angiotensin II receptor antagonists (yes or not) on the effectiveness of the pharmacological treatments for SARS-Cov2 in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of taking oral anti-diabetics drugs on the effectiveness of the pharmacological treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice.
The investigators will analyze the effect of usual taking oral anti-diabetics drugs (yes or not) on the effectiveness of the pharmacological treatments for SARS-Cov2 in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To evaluate the influence of administration of insulin on the effectiveness of the pharmacological treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice.
The investigators will analyze the effect of usual administration of insulin (yes or not) on the effectiveness of the pharmacological treatments for SARS-Cov2 in hospitalized patients assessed in terms of mortality.
Measured: 28 days
To obtain information on the dosage of the pharmacologic treatments used for the treatment of the SARS-Cov2 infection in hospitalized patients and outpatients in clinical practice.
The investigators will collect the dosage of each drug used in clinical practice (amount of drug administered, usually in milligrams, per time interval in hours)
Measured: During the drug treatment, an average of two weeks
To obtain information on the duration of the pharmacologic treatments used for the treatment of the SARS-Cov2 infection in hospitalized patients and outpatients in clinical practice.
The investigators will collect the days of use of each drug.
Measured: During the drug treatment, an average of two weeks
To identify and quantity the side effects of the pharmacologic treatments used for the treatment of the SARS-Cov2 infection in hospitalized patients and outpatients in clinical practice.
The investigators will collect any side effect, the suspected causative drug, start and end data of the side effect, if it is severe or not and the outcome (full recovery, recovery with sequelae or death).
Measured: 3 months
To analyze the effectiveness of the pharmacologic treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice assessed by time of hospitalization.
The investigators will use the hospitalization days of the patients treated with each drug used for the treatment of SARS-Cov2.
Measured: 180 days
To analyze the effectiveness of the pharmacologic treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice assessed by the need to stay in the intensive care unit.
The investigators will analyze the percentage of patients treated with each drug that need admission to the intensive care unit and the mean number of days that they remained in that unit.
Measured: 28 days
To analyze the effectiveness of the pharmacologic treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice assessed by the maximum severity reached during admission.
To determine the maximum level of severity reached, the investigators will use the following classification:
Uncomplicated disease (symptoms of the upper respiratory tract with or without nonspecific symptoms), mild pneumonia (confirmed on chest radiography and without signs of severity, with room air oxygen saturation > 90% and Pneumonia Severity Score (CURB65) ≤ 1), severe pneumonia (failure of > 1 organ or air ambient oxygen saturation < 90% or respiratory rate ≥ 30 rpm), respiratory distress (bilateral infiltrates on chest radiography and oxygenation deficit with partial pressure of oxygen / inspiratory oxygen fraction ≤ 300 mmHg), sepsis (organic dysfunction with an acute change in the Sequential Organ Failure Assessment Score > 2 points) and septic shock (arterial hypotension that persists after administration of resuscitation volume and that requires vasopressors to maintain a mean arterial pressure ≥ 65 mmHg and lactate ≥ 2 mmol / L in the absence of hypovolemia)
Measured: 28 days
To determine the evolution of patients with a positive diagnostic test for SARS-Cov2 who have not been treated with some of the specific drugs for this disease used for hospitalized patients in clinical practice.
To determine the evolution of this group of patient the investigators will use the need admission on the intensive care unit or respiratory intermediate care unit, the need of ventilatory support (conventional oxygen therapy, high-flow oxygen therapy, invasive or non-invasive ventilation, prone position, extracorporeal membrane oxygenation), recovery or death and medical complications during admission (other infections, severe arrhythmia, respiratory distress, kidney failure, heart failure, myocardial infarction, angina, auricular fibrillation / flutter, stroke and others).
Measured: 28 days
To describe the symptoms presented by the hospitalized patient for COVID-19 in the Community of Extremadura during the entire epidemic period
The investigators will collect the presence of the main symptoms on admission: fever, shaking chills, cough, expectoration, hemoptysis, dyspnea, chest pain, headache, diarrhea, asthenia, anorexia, malaise, anosmia, dysgeusia, nasal obstruction, rhinorrhea, odynophagia, myalgia or body pain, weight loss, nausea and vomiting
Measured: 7 days
To describe the temperature presented during admission by patients hospitalized for COVID-19 in the community of Extremadura during the entire period of the pandemic.
The investigators will collect the temperature in degrees centigrade on admission and every seven days during admission
Measured: 28 days
To describe the heart rate presented during admission by patients hospitalized for COVID-19 in the community of Extremadura during the entire period of the pandemic.
The investigators will collect the heart rate in beats per minute on admission and every seven days during admission.
Measured: 28 days
To describe the oxygen saturation breathing ambient air presented during admission by patients hospitalized for COVID-19 in the community of Extremadura during the entire period of the pandemic.
The investigators will collect the oxygen saturation breathing ambient air by arterial blood gases or pulse oximetry, depending on availability, on admission and every seven days during admission.
Measured: 28 days
To describe the blood pressure presented during admission by patients hospitalized for COVID-19 in the community of Extremadura during the entire period of the pandemic.
The investigators will collect the blood pressure in millimeters of mercury on admission and every seven days during admission.
Measured: 28 days
To describe the symptoms presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the presence of the main symptoms during the follow-up: fever, shaking chills, cough, expectoration, hemoptysis, dyspnea, chest pain, headache, diarrhea, asthenia, anorexia, malaise, anosmia, dysgeusia, nasal obstruction, rhinorrhea, odynophagia, myalgia or body pain, weight loss, nausea and vomiting on diagnosis and every seven days during de follow up.
Measured: 28 days
To describe the temperature presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the temperature in degrees centigrade at diagnosis.
Measured: 7 days
To describe heart rate presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the heart rate in beats per minute at diagnosis.
Measured: 7 days
To describe the respiratory rate presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the respiratory rate in breaths per minute at diagnosis
Measured: 7 days
To describe the oxygen saturation breathing ambient air presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the oxygen saturation breathing ambient air by arterial blood gases or pulse oximetry, depending on availability, at diagnosis.
Measured: 7 days
To describe the blood pressure presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the blood pressure in millimeters of mercury at diagnosis.
Measured: 7 days
To describe the radiological findings in hospitalized patients with CIVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the radiological findings of the chest radiograph and the computed tomography (CT) according to two classifications:
Unilateral or bilateral alveolar infiltrate, diffuse intersticial infiltrate, pattern on ground glass, pleural effusion and normal.
Intersticial infiltrate, lobar or bilobar alveolar infiltrate, unilateral or bilateral alveolar lung infiltrate with three degrees of severity (mild, moderate or severe with <25%, 25-50% or >50% of lung affected, respectively), pleural effusion and normal.
These findings will be collected weekly during admission to the conventional ward and daily during admission to intensive or intermediate respiratory care unit.
Measured: 28 days
To describe the radiological findings in outpatients with CIVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the radiological findings of the chest radiograph and the computed tomography (CT) according to two classifications:
Unilateral or bilateral alveolar infiltrate, diffuse intersticial infiltrate, pattern on ground glass, pleural effusion and normal.
Intersticial infiltrate, lobar or bilobar alveolar infiltrate, unilateral or bilateral alveolar lung infiltrate with three degrees of severity (mild, moderate or severe with <25%, 25-50% or >50% of lung affected, respectively), pleural effusion and normal.
These findings will be collected at diagnosis.
Measured: 7 days
To describe the ferritin levels in the blood of hospitalized patients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the ferritin levels in nanogram per milliliter, weekly during admission to the conventional ward and daily during admission to intensive or intermediate respiratory care unit.
Measured: 28 days
To describe the D-dimer levels in the blood of hospitalized patients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the D-dimer levels in nanogram per milliliter, weekly during admission to the conventional ward and daily during admission to intensive or intermediate respiratory care unit.
Measured: 28 days
To describe the interleukin 6 levels in the blood of hospitalized patients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the interleukin 6 levels in picogram per milliliter, weekly during admission to the conventional ward and daily during admission to intensive or intermediate respiratory care unit
Measured: 28 days
To describe the lymphocyte count in the blood of hospitalized patients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the lymphocyte count expressed in 10*3 per milliliter, weekly during admission to the conventional ward and daily during admission to intensive or intermediate respiratory care unit
Measured: 28 days
To describe the c-reactive protein level in the blood of hospitalized patients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the c-reactive protein level in milligrams per deciliters, weekly during admission to the conventional ward and daily during admission to intensive or intermediate respiratory care unit.
Measured: 28 days
To describe the results of SARS-CoV2 diagnostic test performed in hospitalized patients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the result (positive or negative) of all tests performed to confirm the diagnosis of SARS-CoV2 infection: polymerase chain reaction test, serological test and antigen detection test.
Measured: 21 days
To describe the ferritin levels in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the ferritin levels in nanogram per milliliter at diagnosis.
Measured: 7 days
To describe the D-dimer levels in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the D-dimer levels in nanogram per milliliter at diangosis.
Measured: 7 days
To describe the interleukin 6 levels in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the interleukin 6 levels in picogram per milliliter at diagnosis.
Measured: 7 days
To describe the lymphocyte count in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the lymphocyte count expressed in 10*3 per milliliter diagnosis.
Measured: 7 days
To describe the c-reactive protein level in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the c-reactive protein level in milligrams per deciliters at diagnosis.
Measured: 7 days
To describe the results of SARS-CoV2 diagnostic test performed in outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
The investigators will collect the result (positive or negative) of all tests performed to confirm the diagnosis of SARS-CoV2 infection: polymerase chain reaction test, serological test and antigen detection test.
Measured: 14 days
To assess the health-related quality of life perceived by hospitalized patients after recovery.
To determine the quality of life related to health the investigators will use the Short Form-12 Health Survey after recovery. This questionnaire assesses the degree of well-being and functional capacity and it is composed of twelve items and eight dimensions (physical function, physical role, body pain, mental health, general health, vitality, social function and emotional role), defining a positive or negative state of the physical and mental health. Some included items are: "In general, would you say that your health is", "During the last 4 weeks, to what extent has your physical health or emotional problems hindered your usual social activities with family, friends, neighbors or other people? "," Did you have pain in any part of your body during the last 4 weeks? ". The response options form Likert-type scales where the number of options varies from three to six points. The score ranges from 0 to 100. A higher score implies a better health-related quality of life.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start14 Jul 2020
- Primary completion20 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Fernando Masa Jiménez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Fernando Masa Jiménez, University of Extremadura
- Investigators
- Juan F Masa Jiménez, PhD, Principal investigator, Servicio Extremeño de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724850
- Sponsor's protocol ID
- 1/2020
- Acronym
- COVIXTREM
- Status last verified
- May 2024
- First submitted
- 11 Jan 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Additional related documents such as study protocol, statistical analysis plan and informed consent form will be available upon request from the project principal investigator. (Dr. Juan Fernando Masa Jiménez). De-identified patients´data can be requested by researchers for use in independent scientific research and will provided following review and approval of the research proposal (including statistical analysis plan) and completion of a data sharing agreement with the Project Publications Committee. Investigator Data requests can be made anytime from 1 to 2 years after the publication of this trial. Requests should be sent to the corresponding author (Dr. Juan Fernando Masa Jiménez- fmasa@separ.es)
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study About the Characteristics and Evolution of Patients Diagnosed With COVID-19 in Extremadura
- ClinicalTrials.gov ID
- NCT04724850
- Acronym / sponsor ID
- COVIXTREM / 1/2020
- Conditions
- Coronavirus Disease 2019
- Keywords
- Patients diagnosed with coronavirus disease 2019, Clinical characteristics of coronavirus disease 2019, Clinical evolution of coronavirus disease 2019, Effectiveness of drug treatment for coronavirus disease 2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Juan Fernando Masa JiménezUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 26 Jan 2021 (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.
At the end of January 2020, the international community was informed of the presence of a new viral disease that started in Wuhan (China) and spread rapidly throughout the world. The identified virus belonged to the coronavirus family (SARS-CoV-2) and the disease was named COVID-19. Today there are more than 2 million people diagnosed in Spain and more than 40 thousand in Extremadura. The partial knowledge about the development, evolution of the affected citizenship and their prognosis both early and late makes it necessary to analyze in depth their global and particular characteristics.
We will carry out a multicenter, observational, descriptive, cross-sectional and longitudinal study of patients diagnosed with SARS-CoV-2 virus infection in the Community of Extremadura to determine the effectiveness of drug treatments and the clinical and evolutionary characteristics of these patients and the different factors that may influence its evolution.
Detailed description
Epidemiological, socio-sanitary, clinical, analytical and radiological data will be collected retrospectively and prospectively from all patients diagnosed with COVID-19 without hospital admission in our community from the start of the pandemic and for one year from the start of the study.
These data will be obtained mainly from the clinical history and collected in the data collection notebooks and electronic base designed for the study for subsequent analysis. The data collection period will be one year, estimating a sample of 5,000 patients.
In addition, patients included in the study prospectively will be asked for consent to collect a blood sample for freezing and storage in the Biobank of Extremadura and subsequent use to determine biomarkers and genetics.
The present study will be carried out in accordance with the observational National Post-Authorization Study (EPA) for medicines for human use proposed by Valdecilla Health Research Institute (IDIVAL), the main objective of which is to determine the effectiveness of the pharmacological treatments currently used in COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | –All patients diagnosed with COVID-19 in the community of Extremadura from the beginning of the epidemic to its ending in Spain. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with SARS-Cov2 infection according to the clinical and microbiological criteria established by the Health Authorities and clinical practice in the community of Extremadura in Spain, and who require or not hospitalization and who receive or not specific pharmacologic treatment for the SARS-Cov2 infection.
Key inclusion criteria (2 listed)
- Patients of any age and sex, including minors and pregnant women.
- Patients diagnosed with SARS-Cov2 infection according to the clinical and microbiological criteria established by the Health Authorities and clinical practice (these can be modified based on the Technical document "Clinical management of COVID-19" of the Ministry of Health) who require or not hospitalization and who receive or not specific pharmacologic treatment for the SARS-Cov2 infection.
Key exclusion criteria (1 listed)
- Patients who do not give their informed consent to participate in the study.
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
To determine the effectiveness of the pharmacological treatments used for hospitalized patients with COVID-19 in clinical practice assessed in terms of mortality.
Time frame: 28 days
To determine the effectiveness of each drug the investigators will use the percentage of deceased subjects who were treated with each one of them.
To determine the effectiveness of the pharmacological treatments used in the clinical practice for hospitalized patients with SARS-Cov2 infection assessed by time until death.
Time frame: 28 days
To determine the effectiveness of each drug the investigators will use the time in days from the start to the pharmacological treatment to death.
To determine the effectiveness of the pharmacological treatments used in the clinical practice for hospitalized patients with SARS-Cov2 infection assessed in terms of recovery.
Time frame: 28 days
To determine the effectiveness of each drug the investigators will use the time from the start of the pharmacological treatment to recovery, understanding as recovery the disappearance of symptoms and two negative reverse transcription polymerase chain reaction (PCR) separated by at least 24 hours.
53 secondary outcomes
To evaluate the influence of the age on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of the gender on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of the arterial hypertension on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of the diabetes on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of the dyslipidemia on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of myocardial infarction on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of angina on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of chronic heart disease on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of peripheral arterial disease the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of ictus on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To influence of dementia on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of neuromuscular disease on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of chronic obstructive pulmonary disease on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of asthma the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate de influence of chronic kidney disease the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
Time frame: 28 days
To evaluate the influence of the severity of the disease on the effectiveness of the pharmacologic treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice assessed in terms of mortality.
Time frame: 28 days
To evaluate the influence of taking non-steroidal anti-inflammatory drugs on the effectiveness of the pharmacological treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice.
Time frame: 28 days
To evaluate the influence of taking angiotensin II receptor antagonists on the effectiveness of the pharmacological treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice.
Time frame: 28 days
To evaluate the influence of taking oral anti-diabetics drugs on the effectiveness of the pharmacological treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice.
Time frame: 28 days
To evaluate the influence of administration of insulin on the effectiveness of the pharmacological treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice.
Time frame: 28 days
To obtain information on the dosage of the pharmacologic treatments used for the treatment of the SARS-Cov2 infection in hospitalized patients and outpatients in clinical practice.
Time frame: During the drug treatment, an average of two weeks
To obtain information on the duration of the pharmacologic treatments used for the treatment of the SARS-Cov2 infection in hospitalized patients and outpatients in clinical practice.
Time frame: During the drug treatment, an average of two weeks
To identify and quantity the side effects of the pharmacologic treatments used for the treatment of the SARS-Cov2 infection in hospitalized patients and outpatients in clinical practice.
Time frame: 3 months
To analyze the effectiveness of the pharmacologic treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice assessed by time of hospitalization.
Time frame: 180 days
To analyze the effectiveness of the pharmacologic treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice assessed by the need to stay in the intensive care unit.
Time frame: 28 days
To analyze the effectiveness of the pharmacologic treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice assessed by the maximum severity reached during admission.
Time frame: 28 days
To determine the evolution of patients with a positive diagnostic test for SARS-Cov2 who have not been treated with some of the specific drugs for this disease used for hospitalized patients in clinical practice.
Time frame: 28 days
To describe the symptoms presented by the hospitalized patient for COVID-19 in the Community of Extremadura during the entire epidemic period
Time frame: 7 days
To describe the temperature presented during admission by patients hospitalized for COVID-19 in the community of Extremadura during the entire period of the pandemic.
Time frame: 28 days
To describe the heart rate presented during admission by patients hospitalized for COVID-19 in the community of Extremadura during the entire period of the pandemic.
Time frame: 28 days
To describe the oxygen saturation breathing ambient air presented during admission by patients hospitalized for COVID-19 in the community of Extremadura during the entire period of the pandemic.
Time frame: 28 days
To describe the blood pressure presented during admission by patients hospitalized for COVID-19 in the community of Extremadura during the entire period of the pandemic.
Time frame: 28 days
To describe the symptoms presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
Time frame: 28 days
To describe the temperature presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
Time frame: 7 days
To describe heart rate presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
Time frame: 7 days
To describe the respiratory rate presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
Time frame: 7 days
To describe the oxygen saturation breathing ambient air presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
Time frame: 7 days
To describe the blood pressure presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
Time frame: 7 days
To describe the radiological findings in hospitalized patients with CIVID-19 in the Community of Extremadura during the entire epidemic period.
Time frame: 28 days
To describe the radiological findings in outpatients with CIVID-19 in the Community of Extremadura during the entire epidemic period.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Yes. Additional related documents such as study protocol, statistical analysis plan and informed consent form will be available upon request from the project principal investigator. (Dr. Juan Fernando Masa Jiménez). De-identified patients´data can be requested by researchers for use in independent scientific research and will provided following review and approval of the research proposal (including statistical analysis plan) and completion of a data sharing agreement with the Project Publications Committee. Investigator Data requests can be made anytime from 1 to 2 years after the publication of this trial. Requests should be sent to the corresponding author (Dr. Juan Fernando Masa Jiménez- fmasa@separ.es)
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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.
Juan F Masa Jiménez, PhD principal investigator
Servicio Extremeño de Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019, run by Juan Fernando Masa Jiménez at 1 site 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 2 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: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the effectiveness of the pharmacological treatments used for hospitalized patients with COVID-19 in clinical practice assessed in terms of mortality. (time frame: 28 days). The study lists 3 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 8 May 2024.