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CVP-Covid19: CardioVascular Disease Progression and Prognosis in COVID-19

Sponsor
University of Bologna (Other)
Overall Status
Recruiting
CT.gov ID
NCT04606732
Collaborator
(none)
2,000
Enrollment
1
Location
15.3
Anticipated Duration (Months)
130.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The CVP-COVID19 registry is both a retrospective and prospective study design in order to identify predictors of cardiovascular disease progression and mortality for COVID-19. The registry enrolls consecutive patients with positive microbiological tests for SARS-CoV-2 admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms. The study does not test any new diagnostic or therapeutic approach. Patients are treated according to good clinical practice. Patients characteristics, including medical history (with particular attention to cardiovascular and pneumological risk factors), features of physical examination, results laboratory and radiological tests and treatments (pre- and in-hospital) are related with patient outcome. Logistic analysis (univariate, multivariate and propensity) are performed in order to identify factors associated with disease progression. Primary endpoint: mortality.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Members of the Steering Committee:

    Olivia Manfrini (Università di Bologna, Italy) Raffaele Bugiardini (Università di Bologna, Italy) Stefano Nava (Università di Bologna, Italy) Elisabetta Poluzzi (Università di Bologna, Italy) Maria Carla Re (Università di Bologna, Italy) Caterina Vocale (Policlinico Sant'Orsola) Study Coordinator: Edina Cenko (Università di Bologna, Italy)

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cardiovascular Clinical Features and Cardiovascular Therapies in the Development, Progression and Outcome of Patients With SARS-Cov-2 Related Pneumonia
    Actual Study Start Date :
    Sep 20, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [30 days]

      All causes mortality

    2. Mortality [6 months]

      All causes mortality

    3. Mortality [1 year]

      All causes mortality

    Eligibility Criteria

    Criteria

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

    hospitalization for COVID-19

    Exclusion Criteria:

    age <18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Policlinico Sant'Orsola Bologna Italy 40138

    Sponsors and Collaborators

    • University of Bologna

    Investigators

    • Study Director: Maria Carla Re, DIMES, Università di Bologna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Olivia Manfrini, MD, University of Bologna
    ClinicalTrials.gov Identifier:
    NCT04606732
    Other Study ID Numbers:
    • CV_SPP_COVID19
    First Posted:
    Oct 28, 2020
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Olivia Manfrini, MD, University of Bologna
    Cardiovascular Diseases
    Pneumonia, Viral
    SARS-CoV-2
    Covid-12
    ACE receptor
    Additional relevant MeSH terms:
    COVID-19
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Feb 21, 2021