Clinical trial NCT04724850: Evolution of Coronavirus Disease 2019 (COVID-19) Patients in Extremadura
Official title: Observational Study About the Characteristics and Evolution of Patients Diagnosed With COVID-19 in Extremadura
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who do not give their informed consent to participate in the study.

Primary outcomes:
measure: To determine the effectiveness of the pharmacological treatments used for hospitalized patients with COVID-19 in clinical practice assessed in terms of mortality.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
Secondary outcomes:
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: To evaluate the influence of angina on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: To evaluate the influence of ictus on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
timeFrame: 28 days
measure: To influence of dementia on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: To evaluate the influence of asthma the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: During the drug treatment, an average of two weeks
measure: 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.
timeFrame: During the drug treatment, an average of two weeks
measure: 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.
timeFrame: 3 months
measure: To analyze the effectiveness of the pharmacologic treatments used for SARS-Cov2 infection in hospitalized patients in clinical practice assessed by time of hospitalization.
timeFrame: 180 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: To describe the symptoms presented by the hospitalized patient for COVID-19 in the Community of Extremadura during the entire epidemic period
timeFrame: 7 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: To describe the symptoms presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 28 days
measure: To describe the temperature presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: To describe heart rate presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: To describe the respiratory rate presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: To describe the blood pressure presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: To describe the radiological findings in hospitalized patients with CIVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 28 days
measure: To describe the radiological findings in outpatients with CIVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: To describe the ferritin levels in the blood of hospitalized patients with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: To describe the lymphocyte count in the blood of hospitalized patients with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 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.
timeFrame: 21 days
measure: To describe the ferritin levels in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: To describe the D-dimer levels in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: To describe the interleukin 6 levels in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: To describe the lymphocyte count in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 14 days
measure: To assess the health-related quality of life perceived by hospitalized patients after recovery.
timeFrame: Up to six months
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
Study officials:
affiliation: Servicio Extremeño de Salud
name: Juan F Masa Jiménez, PhD
role: PRINCIPAL_INVESTIGATOR
References: