Clinical trial NCT05102708: Study of COVID-19 Prognostic Factors in Hospitalized Patients
Official title: Study of COVID-19 Prognostic Factors in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Prognostic Factors
COVID-19
Hospitalization
Critical care
All-cause mortality
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 3725
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult COVID-19 patients hospitalized at the San Pau Hospital of Barcelona between March 2020 and February 2021.

Brief summary: Severe COVID-19 prognostic factors have been studied worldwide throughout the pandemic, but there is considerable variability. Therefore, the investigators will summarize the identified prognostic factors in the international literature and will conduct a retrospective cohort study to identify the prognostic factors of severe COVID-19 in hospitalized patients of the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain) between March 2020 and February 2021, compare them with those mentioned in the international literature and establish those most adequate to our population.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Equal or older than 18 years old
* Hospitalized between March 1st, 2020, and February 28th, 2021.
* Be diagnosed with COVID-19 disease

Exclusion Criteria:

* Underaged patients
* \> 16h stay in the Emergency Unit

Primary outcomes:
measure: All cause mortality
timeFrame: one year
measure: Critical care admission
timeFrame: one year
measure: Length of stay
timeFrame: one year
measure: 30-day all cause mortality
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Teresa Puig, MD, PhD, MSC
role: PRINCIPAL_INVESTIGATOR
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