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Study of COVID-19 Prognostic Factors in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT05102708
Recruitment Status : Completed
First Posted : November 1, 2021
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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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 disease Intervention/treatment
COVID-19 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
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Study Type : Observational
Actual Enrollment : 3725 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. All cause mortality [ Time Frame: one year ]
    All cause mortality of COVID-19 inpatients

  2. Critical care admission [ Time Frame: one year ]
    Critical care admission of COVID-19 inpatients

  3. Length of stay [ Time Frame: one year ]
    length of hospital stay equal or longer than 30 days

  4. 30-day all cause mortality [ Time Frame: one year ]
    30-day all cause mortality of COVID-19 inpatients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Teresa Puig, MD, PhD, MSC Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Additional Information:

Publications:

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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: November 1, 2021    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Prognostic Factors
COVID-19
Hospitalization
Critical care
All-cause mortality
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases