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

Sponsor

Hospital Universitari Joan XXIII de Tarragona. (Other)

Overall Status

Recruiting

CT.gov ID

NCT04948242

Collaborator

Sociedad Española de Medicina Intensiva,critica y unidades coronarias (Other)

5,000

Enrollment

Location

36.6

Anticipated Duration (Months)

136.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2 Infection

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 12, 2019

Actual Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Support respiratory type and prognosis [Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU lenght of stay and ICU discharge]
Association between respiratory support used at ICU admission and ICU mortalily
Comorbidities and prognosis [Observational period from ICU admission to data of discharge alive or date of death from any cause at days 28 of ICU lenght of stay and ICU discharge]
Association between different comorbidities (diabetes, obesity, hypertension, etc) and ICU mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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