The Geneva Covid-19 CVD Study

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384029
• Other study ID #: CCER-2020-00610
• Status: Completed
• Start date: March 24, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1927
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID
• CVD

Intervention

Other:
• Covid-19 + patients
all the patients hospitalized in Geneva and SARS-Cov2 positive

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital (HUG)	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
François MACH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mobidity discharge	To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.	0 days after hospitalization
Primary	mobidity at 30 days	To compare morbidity 30 days after hospitalization in COVID-19+ patients with or without preexisting CVD.	30 days after hospitalization
Primary	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
Primary	mortality discharge	To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.	0 days after hospitalization
Primary	mortality 30 days after hospitalization	To comparemortality30 days after hospital stay in COVID-19+ patients with or without preexisting CVD.	30 days after hospitalization
Primary	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	Clinical outcomes according to medication at admission	Clinical outcomes according to medication at admission evaluated at hospital discharge	0 days after hospitalization
Secondary	Clinical outcomes according to medication at admission	Clinical outcomes according to medication at admission evaluated 30 days after hospitalization	30 days after hospitalization
Secondary	Clinical outcomes according to medication at admission	1 year after hospitalization	1 year after hospitalization
Secondary	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
Secondary	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
Secondary	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
Secondary	New onset of CVD induced by COVID-19 disease	New onset of CVD induced by COVID-19 disease at discharge	0 days after hospitalization
Secondary	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
Secondary	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
Secondary	Cost of hospital stay	Cost of hospital stay	0 days after hospitalization
Secondary	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
Secondary	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