Study of COVID-19 Prognostic Factors in Hospitalized Patients

Completed

• Conditions: COVID-19

• Registration Number: NCT05102708
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-01
• Study Start: 2021-11-25
• Primary Completion: 2021-12-31
• Study Completion: 2022-05-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3725

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Critical care admission	one year	Critical care admission of COVID-19 inpatients
All cause mortality	one year	All cause mortality of COVID-19 inpatients
Length of stay	one year	length of hospital stay equal or longer than 30 days
30-day all cause mortality	one year	30-day all cause mortality of COVID-19 inpatients

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain