The Geneva Covid-19 CVD Study

• Sponsor: François MACH (Other)
• Overall Status: Completed
• CT.gov ID: NCT04384029
• Collaborator: (none)
• Enrollment: 1,927
• Location: 1
• Actual Duration (Months): 16.2
• Patients Per Site Per Month: 118.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID; CVD	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 Design

• Study Type: Observational
• Actual Enrollment: 1927 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Actual Study Start Date: Mar 24, 2020
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jul 31, 2021

Outcome Measures

Primary Outcome Measures

1. mobidity discharge [0 days after hospitalization]

   To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.

2. mobidity at 30 days [30 days after hospitalization]

   To compare morbidity 30 days after hospitalization in COVID-19+ patients with or without preexisting CVD.

3. mobidity 1 year after hospitalization [1 year after hospitalization]

   To compare morbidity 1 year after hospitalization stay in COVID-19+ patients with or without preexisting CVD.

4. mortality discharge [0 days after hospitalization]

   To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.

5. mortality 30 days after hospitalization [30 days after hospitalization]

   To comparemortality30 days after hospital stay in COVID-19+ patients with or without preexisting CVD.

6. mortality 1 year after hospitalization [1 year after hospitalization]

   To compare mortality 1 year after hospital stay in COVID-19+ patients with or without preexisting CVD.

Secondary Outcome Measures

1. Clinical outcomes according to medication at admission [0 days after hospitalization]

   Clinical outcomes according to medication at admission evaluated at hospital discharge

2. Clinical outcomes according to medication at admission [30 days after hospitalization]

   Clinical outcomes according to medication at admission evaluated 30 days after hospitalization

3. Clinical outcomes according to medication at admission [1 year after hospitalization]

   1 year after hospitalization

4. Clinical outcomes related to preexisting cardiovascular risk factors at admission [0 days after hospitalization]

   Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated after hospital discharge

5. Clinical outcomes related to preexisting cardiovascular risk factors at admission [30 days after hospitalization]

   Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 30 days after hospital discharge

6. Clinical outcomes related to preexisting cardiovascular risk factors at admission [1 year after hospitalization]

   Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 1 year after hospitalization

7. New onset of CVD induced by COVID-19 disease [0 days after hospitalization]

   New onset of CVD induced by COVID-19 disease at discharge

8. New onset of CVD induced by COVID-19 disease [30 days after hospitalization]

   New onset of CVD induced by COVID-19 disease evaluated 30 days after hospitalization

9. New onset of CVD induced by COVID-19 disease [1 year after hospitalization]

   New onset of CVD induced by COVID-19 disease at discharge evaluated 1 year after hospitalization

10. Cost of hospital stay [0 days after hospitalization]

    Cost of hospital stay

11. 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 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).

12. Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis). [1 year after hospitalization]

    Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva University Hospital (HUG)	Geneva		Switzerland	1211

Sponsors and Collaborators

• François MACH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: François MACH, Professor François MACH, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT04384029
• Other Study ID Numbers: CCER-2020-00610
• First Posted: May 12, 2020
• Last Update Posted: Oct 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 19, 2021