The Geneva Covid-19 CVD Study

October 18, 2021 updated by: François MACH

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1927

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mobidity discharge
Time Frame: 0 days after hospitalization
To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.
0 days after hospitalization
mobidity at 30 days
Time Frame: 30 days after hospitalization
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
Time Frame: 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
Time Frame: 0 days after hospitalization
To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.
0 days after hospitalization
mortality 30 days after hospitalization
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical outcomes according to medication at admission
Time Frame: 0 days after hospitalization
Clinical outcomes according to medication at admission evaluated at hospital discharge
0 days after hospitalization
Clinical outcomes according to medication at admission
Time Frame: 30 days after hospitalization
Clinical outcomes according to medication at admission evaluated 30 days after hospitalization
30 days after hospitalization
Clinical outcomes according to medication at admission
Time Frame: 1 year after hospitalization
1 year after hospitalization
1 year after hospitalization
Clinical outcomes related to preexisting cardiovascular risk factors at admission
Time Frame: 0 days after hospitalization
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
Time Frame: 30 days after hospitalization
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
Time Frame: 1 year after hospitalization
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
Time Frame: 0 days after hospitalization
New onset of CVD induced by COVID-19 disease at discharge
0 days after hospitalization
New onset of CVD induced by COVID-19 disease
Time Frame: 30 days after hospitalization
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
Time Frame: 1 year after hospitalization
New onset of CVD induced by COVID-19 disease at discharge evaluated 1 year after hospitalization
1 year after hospitalization
Cost of hospital stay
Time Frame: 0 days after hospitalization
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).
Time Frame: 30 days after hospitalization
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).
Time Frame: 1 year after hospitalization
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
François MACH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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