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The Geneva Covid-19 CVD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384029
Recruitment Status : Completed
First Posted : May 12, 2020
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
François MACH, University Hospital, Geneva

Tracking Information
First Submitted Date April 20, 2020
First Posted Date May 12, 2020
Last Update Posted Date October 19, 2021
Actual Study Start Date March 24, 2020
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2020)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 7, 2020)
  • Clinical outcomes according to medication at admission [ Time Frame: 0 days after hospitalization ]
    Clinical outcomes according to medication at admission evaluated at hospital discharge
  • 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
  • Clinical outcomes according to medication at admission [ Time Frame: 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Cost of hospital stay [ Time Frame: 0 days after hospitalization ]
    Cost of hospital stay
  • 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).
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • COVID
  • CVD
Intervention Other: Covid-19 + patients
all the patients hospitalized in Geneva and SARS-Cov2 positive
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 18, 2021)		 1927
Original Estimated Enrollment
 (submitted: May 7, 2020)		 7000
Actual Study Completion Date July 31, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04384029
Other Study ID Numbers CCER-2020-00610
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party François MACH, University Hospital, Geneva
Original Responsible Party Same as current
Current Study Sponsor François MACH
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Geneva
Verification Date October 2021