NCT04384029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,927

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

April 20, 2020

Last Update Submit

October 18, 2021

Conditions

COVIDCVD

Outcome Measures

Primary Outcomes (6)

  • mobidity discharge

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

    0 days after hospitalization

  • mobidity at 30 days

    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

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

    1 year after hospitalization

  • mortality discharge

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

    0 days after hospitalization

  • mortality 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

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

    1 year after hospitalization

Secondary Outcomes (12)

  • Clinical outcomes according to medication at admission

    0 days after hospitalization

  • Clinical outcomes according to medication at admission

    30 days after hospitalization

  • Clinical outcomes according to medication at admission

    1 year after hospitalization

  • Clinical outcomes related to preexisting cardiovascular risk factors at admission

    0 days after hospitalization

  • Clinical outcomes related to preexisting cardiovascular risk factors at admission

    30 days after hospitalization

  • +7 more secondary outcomes

Interventions

Covid-19 + patientsOTHER

all the patients hospitalized in Geneva and SARS-Cov2 positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients unwilling to provide informed consent for the follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital (HUG)

Geneva, 1211, Switzerland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor François MACH

Study Record Dates

First Submitted

April 20, 2020

First Posted

May 12, 2020

Study Start

March 24, 2020

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

CH(1)