NCT04537559

Brief Summary

The Geneva Canton organized the health crisis of the COVID-19 epidemic around the care of COVID patients at the University Hospital (HUG), by moving the care of non-COVID patients to private hospitals of the canton. The COVID epidemic appears to have been associated with a decrease in consultations and care for non-COVID patients. An excess of morbidity and mortality (non-COVID) would be possible during or after the epidemic in connection with this "under-medicalization" of non-COVID patients. The aim of this study is to measure and analyze the impact on the morbidity and mortality of inpatients during and after the COVID-19 epidemic in the adult inpatient wards of HUG and township hospitals / clinics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

August 27, 2020

Last Update Submit

March 10, 2022

Conditions

Keywords

COVID-19 Outbreaknon COVID-19

Outcome Measures

Primary Outcomes (2)

  • Intra-hospital mortality

    death during hospitalization of each patient

    Assessed at the discharge date, up to 3 months after admission

  • composite outcome (worsening during hospitalization)

    intra-hospital mortality and / or transfer to intensive care and / or transfer to intermediate care during hospitalization

    At the discharge date of hospitalization, up to 3 months after admission

Secondary Outcomes (66)

  • Pathologies leading to hospitalization

    At the discharge date of hospitalization, up to 3 months after admission

  • overall mortality at 3 months (90 days)

    within the 3 months after the admission date

  • Potentially avoidable readmission rate

    During the 30 days after the patient's discharge

  • mortality rate by pathology at 3 months

    within the 3 months after the admission date

  • length of stay

    At the discharge date of hospitalization, up to 3 months after admission

  • +61 more secondary outcomes

Study Arms (3)

pre-COVID-19 period

Patients hospitalized between 1.3.2019 and 28.02.2020

per-COVID-19 period

Patients hospitalized between 1.3.2020 and 28.02.2022

post-COVID-19 period

Patients hospitalized between 1.3.2022 and 28.02.2023

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients hospitalized in Geneva hospital or clinic from the 1st march 2019 to 28 february 2023.

You may qualify if:

  • Patient hospitalized in an adult department
  • During the pre-period-COVID-19 period, the per-COVID-19 or the post-COVID-19 periods ie from the 1st march 2019 to 28 february 2023.

You may not qualify if:

  • Patients who have been hospitalized for COVID-19 infection
  • Patients hospitalized in the Department of Adolescent Woman and Child, Department of Psychiatry or Intensive Care Department during the same periods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, Canton of Geneva, 1255, Switzerland

Location

Related Publications (5)

  • Welt FGP, Shah PB, Aronow HD, Bortnick AE, Henry TD, Sherwood MW, Young MN, Davidson LJ, Kadavath S, Mahmud E, Kirtane AJ; American College of Cardiology's Interventional Council and the Society for Cardiovascular Angiography and Interventions. Catheterization Laboratory Considerations During the Coronavirus (COVID-19) Pandemic: From the ACC's Interventional Council and SCAI. J Am Coll Cardiol. 2020 May 12;75(18):2372-2375. doi: 10.1016/j.jacc.2020.03.021. Epub 2020 Mar 19. No abstract available.

    PMID: 32199938BACKGROUND
  • Garcia S, Albaghdadi MS, Meraj PM, Schmidt C, Garberich R, Jaffer FA, Dixon S, Rade JJ, Tannenbaum M, Chambers J, Huang PP, Henry TD. Reduction in ST-Segment Elevation Cardiac Catheterization Laboratory Activations in the United States During COVID-19 Pandemic. J Am Coll Cardiol. 2020 Jun 9;75(22):2871-2872. doi: 10.1016/j.jacc.2020.04.011. Epub 2020 Apr 10. No abstract available.

    PMID: 32283124BACKGROUND
  • Roffi M, Guagliumi G, Ibanez B. The Obstacle Course of Reperfusion for ST-Segment-Elevation Myocardial Infarction in the COVID-19 Pandemic. Circulation. 2020 Jun 16;141(24):1951-1953. doi: 10.1161/CIRCULATIONAHA.120.047523. Epub 2020 Apr 21. No abstract available.

    PMID: 32315205BACKGROUND
  • Rosenbaum L. The Untold Toll - The Pandemic's Effects on Patients without Covid-19. N Engl J Med. 2020 Jun 11;382(24):2368-2371. doi: 10.1056/NEJMms2009984. Epub 2020 Apr 17. No abstract available.

    PMID: 32302076BACKGROUND
  • Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967 Oct;20(4):457-64. doi: 10.1016/0002-9149(67)90023-9. No abstract available.

    PMID: 6059183BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jerome Stirnemann, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 3, 2020

Study Start

March 1, 2019

Primary Completion

February 28, 2022

Study Completion

February 28, 2023

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations