COVIDNCT04384029
The Geneva Covid-19 CVD Study
An observational study of COVID and CVD, run by François MACH at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Covid-19 + patients
- How many people
- 1,927 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Mar 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients unwilling to provide informed consent for the follow-up.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Being tested
- Covid-19 + patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 + patientsOther
all the patients hospitalized in Geneva and SARS-Cov2 positive
What is being measured
The primary outcome is the main question the study is designed to answer.
mobidity discharge
To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.
Measured: 0 days after hospitalization
mobidity at 30 days
To compare morbidity 30 days after hospitalization in COVID-19+ patients with or without preexisting CVD.
Measured: 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.
Measured: 1 year after hospitalization
mortality discharge
To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.
Measured: 0 days after hospitalization
mortality 30 days after hospitalization
To comparemortality30 days after hospital stay in COVID-19+ patients with or without preexisting CVD.
Measured: 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.
Measured: 1 year after hospitalization
Secondary outcomes (12)
Clinical outcomes according to medication at admission
Clinical outcomes according to medication at admission evaluated at hospital discharge
Measured: 0 days after hospitalization
Clinical outcomes according to medication at admission
Clinical outcomes according to medication at admission evaluated 30 days after hospitalization
Measured: 30 days after hospitalization
Clinical outcomes according to medication at admission
1 year after hospitalization
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year after hospitalization
New onset of CVD induced by COVID-19 disease
New onset of CVD induced by COVID-19 disease at discharge
Measured: 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
Measured: 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
Measured: 1 year after hospitalization
Cost of hospital stay
Cost of hospital stay
Measured: 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).
Measured: 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).
Measured: 1 year after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start24 Mar 2020
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- François MACH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, François MACH, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384029
- Sponsor's protocol ID
- CCER-2020-00610
- Status last verified
- Oct 2021
- First submitted
- 20 Apr 2020
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04384029
- Acronym / sponsor ID
- CCER-2020-00610
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,927 participants (actual)
- Lead sponsor
- François MACHUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients unwilling to provide informed consent for the follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covid-19 + patientsall the patients hospitalized in Geneva and SARS-Cov2 positive | Other | – |
Primary outcome
mobidity discharge
Time frame: 0 days after hospitalization
To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.
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.
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.
mortality discharge
Time frame: 0 days after hospitalization
To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.
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.
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.
12 secondary outcomes
Clinical outcomes according to medication at admission
Time frame: 0 days after hospitalization
Clinical outcomes according to medication at admission
Time frame: 30 days after hospitalization
Clinical outcomes according to medication at admission
Time frame: 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
Time frame: 30 days after hospitalization
Clinical outcomes related to preexisting cardiovascular risk factors at admission
Time frame: 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
Time frame: 30 days after hospitalization
New onset of CVD induced by COVID-19 disease
Time frame: 1 year after hospitalization
Cost of hospital stay
Time frame: 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 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).
Time frame: 1 year after hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and CVD, run by François MACH at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mobidity discharge (time frame: 0 days after hospitalization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.