Clinical trial NCT04384029: The Geneva Covid-19 CVD Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
CVD
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 1927
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: mobidity discharge
timeFrame: 0 days after hospitalization
measure: mobidity at 30 days
timeFrame: 30 days after hospitalization
measure: mobidity 1 year after hospitalization
timeFrame: 1 year after hospitalization
measure: mortality discharge
timeFrame: 0 days after hospitalization
measure: mortality 30 days after hospitalization
timeFrame: 30 days after hospitalization
measure: mortality 1 year after hospitalization
timeFrame: 1 year after hospitalization
Secondary outcomes:
measure: Clinical outcomes according to medication at admission
timeFrame: 0 days after hospitalization
measure: Clinical outcomes according to medication at admission
timeFrame: 30 days after hospitalization
measure: Clinical outcomes according to medication at admission
timeFrame: 1 year after hospitalization
measure: Clinical outcomes related to preexisting cardiovascular risk factors at admission
timeFrame: 0 days after hospitalization
measure: Clinical outcomes related to preexisting cardiovascular risk factors at admission
timeFrame: 30 days after hospitalization
measure: Clinical outcomes related to preexisting cardiovascular risk factors at admission
timeFrame: 1 year after hospitalization
measure: New onset of CVD induced by COVID-19 disease
timeFrame: 0 days after hospitalization
measure: New onset of CVD induced by COVID-19 disease
timeFrame: 30 days after hospitalization
measure: New onset of CVD induced by COVID-19 disease
timeFrame: 1 year after hospitalization
measure: Cost of hospital stay
timeFrame: 0 days after hospitalization
measure: Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).
timeFrame: 30 days after hospitalization
measure: Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).
timeFrame: 1 year after hospitalization
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital (HUG)
Study officials:
References: