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

NCT04724850 | Completed

• 1 other identifier: 1/2020
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

  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 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 the dyslipidemia on the effectiveness of the pharmacological treatments used for hospitalized patients with SARS-Cov2 infection in clinical practice.

  28 days

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Juan Fernando Masa Jiménez: lead

Study Sites (1)

Hospital San Pedro de Alcántara

Cáceres, 10600, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (only for prospectively recruited and consenting patients)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Juan F Masa Jiménez, PhD

  Servicio Extremeño de Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 26, 2021
• Study Start: July 14, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 30, 2022
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)