The Geneva Covid-19 CVD Study

Retrospective Observational Study to Compare the Short, Mid- and Long-term Prognosis and Outcomes of SRAS-CoV-2 Infected Hospitalized Patients With Cardiovascular Disease (CVD) to SARS-CoV-2 Infected Hospitalized Patients Without CVD: The Geneva Covid-19 CVD Study

In this study, the investigators propose to analyse the clinical data of all patients admitted in Geneva University Hospitals (HUG) or in a care center in Geneva who are diagnosed with COVID-19. CVD being one of the most important risk factors for developing a severe form of the disease, the investigators will explore the prognosis and clinical outcomes of those patients according to their CVD history as well as newly onset CVD during hospitalization. Moreover, as further evidence is needed on the use of renin-angiotensin-aldosterone system (RAAS) inhibitors for SARS-CoV-2 infected patients, the investigators will study prognosis and outcomes according to the patients' medications. Finally, the investigators propose to evaluate hospital length of stay and cost. The aim, therefore, is to collect information and scientific evidence from patients hospitalized and diagnosed positive for COVID-19, in order to evaluate if previous (or newly onset) CVD may influence outcomes and costs.

Study Overview

• Status: Completed
• Conditions: COVID; CVD
• Intervention / Treatment: Other: Covid-19 + patients

Detailed Description

Hypothesis:

COVID-19+ hospitalized patients with preexisting CVD or newly onset CVD at time of hospitalization have different clinical outcomes compared to those without CVD and COVID-19+.

Objectives:

The primary aim of this study is to gather observational data, starting from February 1st 2020 until the end of the pandemic, to compare clinical outcomes COVID+ hospitalized patients at HUG or in a care center in Geneva with pre-existing or newly onset CVD, to COVID+ hospitalized patients at HUG or in a care center in Geneva without pre-existing CVD.

The secondary aims of this study are:

• To determine the association between COVID-19 disease and CVD, based on: age, previous CV diseases, CV risks factors, CV medications (e.g. ACE Inhibitors or angiotensin II receptor antagonists)
• To explore CVD profiles that may influence COVID-19 disease outcomes
• To determine the cause of death in CVD patients (either with preexisting CVD or newly diagnosed with CVD)
• To understand the vulnerability of the myocardium (new event of either heart failure, acute coronary syndrome, arrhythmia, myocarditis) in patients with COVID-19 disease.

• Study Type: Observational
• Enrollment (Actual): 1927

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Geneva University Hospital (HUG)

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This observational study will include male and female patients hospitalized with a COVID+ diagnosis at the HUG or in a care center in Geneva.

Description

Inclusion Criteria:

• Subject is ≥18 years of age.
• Patient diagnosed SARS-CoV-2 positive at time of hospitalization.
• In case of the subject accepting the follow-up at 30 days and 1 year, Signed Patient Informed Consent (PIC) form

Exclusion Criteria:

• Patients unwilling to provide informed consent for the follow-up.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mobidity discharge	To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.	0 days after hospitalization
mobidity at 30 days	To compare morbidity 30 days after hospitalization in COVID-19+ patients with or without preexisting CVD.	30 days after hospitalization
mobidity 1 year after hospitalization	To compare morbidity 1 year after hospitalization stay in COVID-19+ patients with or without preexisting CVD.	1 year after hospitalization
mortality discharge	To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.	0 days after hospitalization
mortality 30 days after hospitalization	To comparemortality30 days after hospital stay in COVID-19+ patients with or without preexisting CVD.	30 days after hospitalization
mortality 1 year after hospitalization	To compare mortality 1 year after hospital stay in COVID-19+ patients with or without preexisting CVD.	1 year after hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes according to medication at admission	Clinical outcomes according to medication at admission evaluated at hospital discharge	0 days after hospitalization
Clinical outcomes according to medication at admission	Clinical outcomes according to medication at admission evaluated 30 days after hospitalization	30 days after hospitalization
Clinical outcomes according to medication at admission	1 year after hospitalization	1 year after hospitalization
Clinical outcomes related to preexisting cardiovascular risk factors at admission	Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated after hospital discharge	0 days after hospitalization
Clinical outcomes related to preexisting cardiovascular risk factors at admission	Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 30 days after hospital discharge	30 days after hospitalization
Clinical outcomes related to preexisting cardiovascular risk factors at admission	Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 1 year after hospitalization	1 year after hospitalization
New onset of CVD induced by COVID-19 disease	New onset of CVD induced by COVID-19 disease at discharge	0 days after hospitalization
New onset of CVD induced by COVID-19 disease	New onset of CVD induced by COVID-19 disease evaluated 30 days after hospitalization	30 days after hospitalization
New onset of CVD induced by COVID-19 disease	New onset of CVD induced by COVID-19 disease at discharge evaluated 1 year after hospitalization	1 year after hospitalization
Cost of hospital stay	Cost of hospital stay	0 days after hospitalization
Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).	Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).	30 days after hospitalization
Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).	Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).	1 year after hospitalization

Collaborators and Investigators

• Sponsor: François MACH

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CCER-2020-00610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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