CardioVascular Disease Progression and Prognosis in COVID-19 (CVP-Covid19)

Cardiovascular Clinical Features and Cardiovascular Therapies in the Development, Progression and Outcome of Patients With SARS-Cov-2 Related Pneumonia

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Olivia Manfrini, MD; Phone Number: +393355612175; Email: olivia.manfrini@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico Sant'Orsola
    • Contact: Olivia Manfrini, MD; Phone Number: +390512143778; Email: olivia.manfrini@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms

Description

Inclusion Criteria:

hospitalization for COVID-19

Exclusion Criteria:

age <18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All causes mortality	1 year
Mortality	All causes mortality	30 days
Mortality	All causes mortality	6 months

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Olivia Manfrini, MD, DIMEC, Università di Bologna

Publications and helpful links

General Publications

• Cenko E, Badimon L, Bugiardini R, Claeys MJ, De Luca G, de Wit C, Derumeaux G, Dorobantu M, Duncker DJ, Eringa EC, Gorog DA, Hassager C, Heinzel FR, Huber K, Manfrini O, Milicic D, Oikonomou E, Padro T, Trifunovic-Zamaklar D, Vasiljevic-Pokrajcic Z, Vavlukis M, Vilahur G, Tousoulis D. Cardiovascular disease and COVID-19: a consensus paper from the ESC Working Group on Coronary Pathophysiology & Microcirculation, ESC Working Group on Thrombosis and the Association for Acute CardioVascular Care (ACVC), in collaboration with the European Heart Rhythm Association (EHRA). Cardiovasc Res. 2021 Dec 17;117(14):2705-2729. doi: 10.1093/cvr/cvab298.
• Bergami M, Manfrini O, Nava S, Caramori G, Yoon J, Badimon L, Cenko E, David A, Demiri I, Dorobantu M, Fabin N, Gheorghe-Fronea O, Jankovic R, Kedev S, Ladjevic N, Lasica R, Loncar G, Mancuso G, Mendieta G, Milicic D, Mjehovic P, Pasalic M, Petrovic M, Poposka L, Scarpone M, Stefanovic M, van der Schaar M, Vasiljevic Z, Vavlukis M, Vega Pittao ML, Vukomanovic V, Zdravkovic M, Bugiardini R. Relationship Between Azithromycin and Cardiovascular Outcomes in Unvaccinated Patients With COVID-19 and Preexisting Cardiovascular Disease. J Am Heart Assoc. 2023 Jul 18;12(14):e028939. doi: 10.1161/JAHA.122.028939. Epub 2023 Jul 14. Erratum In: J Am Heart Assoc. 2023 Aug 15;12(16):e027731.
• Bugiardini R, Nava S, Caramori G, Yoon J, Badimon L, Bergami M, Cenko E, David A, Demiri I, Dorobantu M, Fronea O, Jankovic R, Kedev S, Ladjevic N, Lasica R, Loncar G, Mancuso G, Mendieta G, Milicic D, Mjehovic P, Pasalic M, Petrovic M, Poposka L, Scarpone M, Stefanovic M, van der Schaar M, Vasiljevic Z, Vavlukis M, Vega Pittao ML, Vukomanovic V, Zdravkovic M, Manfrini O. Sex differences and disparities in cardiovascular outcomes of COVID-19. Cardiovasc Res. 2023 May 22;119(5):1190-1201. doi: 10.1093/cvr/cvad011.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Cardiovascular Diseases; Pneumonia, Viral; Covid-12; ACE receptor
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Cardiovascular Diseases
• Other Study ID Numbers: CV_SPP_COVID19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No