Study of COVID-19 Prognostic Factors in Hospitalized Patients

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05102708
Collaborator
(none)
4,000
Enrollment
1
Location
2.1
Anticipated Duration (Months)
1902.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Prognostic factors of severe COVID-19

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 Design

Study Type:
Observational
Anticipated Enrollment :
4000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Study of COVID-19 Prognostic Factors in Hospitalized Patients
Anticipated Study Start Date :
Nov 25, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jan 28, 2022

Outcome Measures

Primary Outcome Measures

  1. All cause mortality [one year]

    All cause mortality of COVID-19 inpatients

  2. Critical care admission [one year]

    Critical care admission of COVID-19 inpatients

  3. Length of stay [one year]

    length of hospital stay equal or longer than 30 days

  4. 30-day all cause mortality [one year]

    30-day all cause mortality of COVID-19 inpatients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hospital de la Santa Creu i Sant PauBarcelonaSpain08041

Sponsors and Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Teresa Puig, MD, PhD, MSC, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT05102708
Other Study ID Numbers:
  • IIBSP-COV-2021-75
First Posted:
Nov 1, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021