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

Recruiting

• Conditions: SARS-CoV2 Infection

• Registration Number: NCT04948242
• Lead Sponsor: Hospital Universitari Joan XXIII de Tarragona.

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.

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 Timeline

• Study Start: 2019-12-12
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-01
• Status Verified: 2023-04
• Primary Completion: 2023-04-17
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-20
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 length of stay and ICU discharge	To determine demographics and clinical factors associated with ICU mortality at days-28 and ICU discharge

Secondary Outcome Measures

Name	Time	Method
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 length of stay and ICU discharge	Association between respiratory support used at ICU admission and ICU mortality
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 length of stay and ICU discharge	Association between different comorbidities (diabetes, obesity, hypertension, etc) and ICU mortality

Trial Locations

Locations (1)

Hospital Universitario de Tarragona Joan XXIII; 🇪🇸 Tarragona, Spain