Evolution of Coronavirus Disease 2019 (COVID-19) Patients in Extremadura (COVIXTREM)

Juan Fernando Masa Jiménez

Status

Completed

Conditions

Coronavirus Disease 2019

Study type

Observational

Funder types

Other

Identifiers

NCT04724850

1/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

440 patients

Sex

All

Volunteers

No Healthy Volunteers

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