Study of COVID-19 Prognostic Factors in Hospitalized Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05102708|
Recruitment Status : Completed
First Posted : November 1, 2021
Last Update Posted : September 6, 2022
|Condition or disease||Intervention/treatment|
|COVID-19||Other: Prognostic factors of severe COVID-19|
Background: Spain is one of the European countries most affected by the SARS-CoV-2 pandemic, with a fatality rate of 2.2%. Faced with the significant number of patients requiring intensive care, the number of beds increased considerably in the span of 11 months to respond to the situation. There is still no drug treatment or specific prognostic factors for COVID-19 that allow its proper management.
Objective: To study the prognostic factors of severity due to COVID-19 in hospitalized patients at Hospital de la Santa Creu i Sant Pau, and their comparison with the prognostic factors identified in the literature review.
Methods: In a first phase, the published studies will be reviewed to identify the existing prognostic factors through various platforms (MEDLINE, EMBASE, Cochrane). A retrospective cohort study will subsequently be carried out to determine the patients' characteristics and to identify the prognostic factors of severity. Patients over 18 years of age, diagnosed with COVID-19 and hospitalized between March 01, 2020 and February 28, 2021 will be included. A descriptive analysis of the cohort will firstly be performed, followed by an analysis of the possible prognostic factors through bivariate tests and multivariate analyzes. The occurrence of admission to intensive care, mortality, and hospital stay > 30 days will be calculated with logistic regression (p <0.05, a = 0.05, 95% confidence interval). Finally, the prognostic factors identified in the literature review will be compared with those determined in the cohort.
|Study Type :||Observational|
|Actual Enrollment :||3725 participants|
|Official Title:||Study of COVID-19 Prognostic Factors in Hospitalized Patients|
|Actual Study Start Date :||November 25, 2021|
|Actual Primary Completion Date :||December 31, 2021|
|Actual Study Completion Date :||May 28, 2022|
- Other: Prognostic factors of severe COVID-19
prognostic factors: patients´ epidemiological characteristics (such as age, sex), comorbidities, length of hospitalization, critical care admission, treatments received, laboratory results, vital signs.
- All cause mortality [ Time Frame: one year ]All cause mortality of COVID-19 inpatients
- Critical care admission [ Time Frame: one year ]Critical care admission of COVID-19 inpatients
- Length of stay [ Time Frame: one year ]length of hospital stay equal or longer than 30 days
- 30-day all cause mortality [ Time Frame: one year ]30-day all cause mortality of COVID-19 inpatients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102708
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08041|
|Principal Investigator:||Teresa Puig, MD, PhD, MSC||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|