Observational Study About the Characteristics and Evolution of Patients Diagnosed With COVID-19 in Extremadura
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- To determine the effectiveness of the pharmacological treatments used for hospitalized patients with COVID-19 in clinical practice assessed in terms of mortality.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who do not give their informed consent to participate in the study.
结局指标
主要结局
To determine the effectiveness of the pharmacological treatments used for hospitalized patients with COVID-19 in clinical practice assessed in terms of mortality.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- 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.(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.(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.(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.(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.(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.(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.(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.(28 days)
- To influence of dementia on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.(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.(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.(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.(28 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.(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.(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.(7 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.(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.(28 days)
- To describe the temperature presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.(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.(7 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.(21 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.(7 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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(28 days)
- To describe the symptoms presented by the hospitalized patient for COVID-19 in the Community of Extremadura during the entire epidemic period(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.(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.(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.(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.(28 days)
- To describe the symptoms presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.(28 days)
- To describe the radiological findings in hospitalized patients with CIVID-19 in the Community of Extremadura during the entire epidemic period.(28 days)
- To describe heart rate presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.(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.(7 days)
- To assess the health-related quality of life perceived by hospitalized patients after recovery.(Up to six months)
- To describe the blood pressure presented by the outpatients diagnosed with COVID-19 in the Community of Extremadura during the entire epidemic period.(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.(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.(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.(28 days)
- To describe the radiological findings in outpatients with CIVID-19 in the Community of Extremadura during the entire epidemic period.(7 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.(28 days)
- To describe the ferritin levels in the blood of outpatients with COVID-19 in the Community of Extremadura during the entire epidemic period.(7 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.(28 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.(14 days)
研究者
Juan Fernando Masa Jiménez
Principal Investigator
University of Extremadura