Characteristics of Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection (COVID-19) (GETCOV-2)

April 17, 2023 updated by: Alejandro Rodriguez Oviedo , MD, Hospital Universitari Joan XXIII de Tarragona.

Epidemiologic, Clinical Characteristics and Risk Factors of Critical Ill Patients Admitted to the ICU for Severe Acute Respiratory Syndrome Coronavirus 2 Infection (COVID-19)

A multicenter observational, prospective cohort study that consisted of a large-scale data source of hospital ICU admissions and patient-level clinical data in Spain.

The main objective is to develop a national database belonging to SEMICYUC (Spanish Society of Critical Care) to describe epidemiological and clinical characteristics and risk factors related to ICU mortality in critically ill patients admitted to ICU due to severe COVID-19 in Spain.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Design: A multicenter observational, prospective cohort study

Setting: Intensive Care Units

Subjects: Adult Critical patients admitted to ICU with severe community-acquired pneumonia due to confirmed SARS CoV-2 infection (COVID-19).

Data Collection and Validation Data was obtained from a voluntary registry created by Spanish Society of Intensive Care Medicine-SEMICYUC. All consecutive cases admitted to the ICU were collected.

There were no patients excluded from the analysis that was enrolled to participating ICU and met criteria.

Data were collected using a paper CRF (case Report Form). CRF collect and record all protocol-required information, which is transcribed from patient source documents, such as hospital records and laboratory reports during the patient's participation in the study. Before being sent to the National Study Coordinator (AR) this data was de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. We implemented a double data entry model for potential errors in real-time. Data was entered twice by two different Data Entry personnel based on the same set of data collected in the paper CRFs. All data were reviewed, and values that appeared incongruent or out of range were manually validated by confirming the accuracy of the data with the Study Coordinator (AR). The database was validated and cleaned before the statistical analysis and the study database was locked to prevent any further changes, and to ensure data consistency and integrity for the statistical reporting and analysis.

Sample size calculation:

No statistical sample size calculation was performed a priori, and sample size was equal to the number of patients admitted to the participant's ICUs with confirmed COVID-19 during the study period.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alejandro Rodríguez Oviedo, MD,PhD,MsC
  • Phone Number: +34977295818
  • Email: ahr1161@yahoo.es

Study Contact Backup

  • Name: Sandra Trefler Crespo, BsC,PhD
  • Phone Number: +34977295818
  • Email: sitrefler@yahoo.es

Study Locations

  • Spain
      • Tarragona, Spain, 43007
        • Recruiting
        • Hospital Universitario de Tarragona Joan XXIII
        • Contact:
          • Alejandro Rodríguez Oviedo, MD,PhD,MsC
          • Phone Number: +34977295818
          • Email: ahr1161@yahoo.es
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients with community-acquired pneumonia due to SARS-CoV-2 infection

Description

Inclusion Criteria:

  1. Severe community-acquired pneumonia due SARS CoV-2 infection and acute respiratory failure with microbiological confirmation (RT-PCR) according international guidelines
  2. Age >= 16 years without upper limit

Exclusion Criteria:

  1. Age < 16 years
  2. Patients with SARS-CoV-2 infection without acute respiratory failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Consecutive critically ill patients admitted to ICU with severe SARS-CoV-2 infection
Consecutive adult patients (> 16 years) with laboratory confirmed SARS-CoV-2 infection, detected by RT-PCR positive test of nasopharyngeal, oropharyngeal , swab or invasive respiratory samples according to the WHO recommendations. The follow-up of patients was to ICU discharge or death whichever occurred first. No interventions will be made. Only anonymized demographic data, clinical data, laboratory data and ventilatory support data will be collected. There is no standardized pharmacological treatment protocol. Only basic data are collected about the different treatments administered by the attending physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiologic and Clinical Characteristics and risk factors for ICU mortality in critically ill patients with COVID-19 in Spain
Time Frame: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
To determine demographics and clinical factors associated with ICU mortality at days-28 and ICU discharge
Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Support respiratory type and prognosis
Time Frame: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
Association between respiratory support used at ICU admission and ICU mortality
Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
Comorbidities and prognosis
Time Frame: Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge
Association between different comorbidities (diabetes, obesity, hypertension, etc) and ICU mortality
Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU length of stay and ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Joan XXIII de Tarragona.

Collaborators

Sociedad Española de Medicina Intensiva,critica y unidades coronarias

Investigators

  • Study Director: Alejandro Rodriguez Oviedo, MD,PhD,MsC, Hospital Universitari de Tarragona Joan XXIII

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Actual)

April 17, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19/SEMICYUC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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