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COVID-19NoCOVImpactNCT04537559

Impact of COVID-19 Outbreak on Non-COVID-19 Patients

An observational study of COVID-19, run by University Hospital, Geneva at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
COVID-19
How many people
240,000 participants
Where
1 siteSwitzerland
Study dates
1 Mar 2019to 28 Feb 2023
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Geneva University Hospital

    Geneva, Canton of Geneva, 1255

Other trials in Switzerland

About this study

Official title: Impact of the COVID-19 Pandemic on the Morbidity and Mortality of Non-COVID-19 Patients Hospitalized Around the Epidemic Peak in the Geneva Area (Switzerland) (No COVID Impact)

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.

Read the detailed description

The analysis of the various results will be carried out on all HUGs and on the various hospitals / clinics in the canton.

A survival analysis for the outcome of death or rehospitalization will be performed, with a comparison according to each period.

After epidemy evolution, finally, the outcomes will be compared between periods pre-COVID (from 01 march 2019 to 28 february 2020) versus per-COVID (01 march 2020 to 28 february 2022), and versus post-COVID (01 march 2022 to 28 february 2023). And comparaison would be performed between periods during the wave (per-wave) versus periods inter-wave.

A description will be made in number (%) for numerical data and in median (IQR) for quantitative data. Univariate comparisons between the different periods will be carried out by statistical tests, parametric or not, adapted according to the data (Chi2 or Fisher's test for qualitative data, Student's test or Mann-Whitney-Wilcoxon for quantitative data). Statistical significance will be retained in the event of p <0.05.

Multivariate analysis will be performed by logistic regression for the main outcome and by cox model for survival analysis. Different variables will be included in the models, including data on gender, age and comorbidity, as well as any variable having a difference with p <0.2 in univariate analysis.

Secondary analyzes will be carried out by pathology (as the main diagnosis) according to the specific results defined for each situation. In retrospective analysis, these specific data will be relatively limited on the HUG area of full analysis brings together around total of 240,000 hospital stays. The main outcome data will be complete with no missing data. On the other hand, since this is retrospective data, it is possible that some important variables are missing. In this case, other patient data with missing data will not be included in the multivariate analyzes. In the event of missing data greater than 10%, a second sensitivity analysis may be performed after replacing the missing data with a multiple imputation method.

Conditions
COVID-19
Keywords
COVID-19 Outbreak, non COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04537559
Study groupRoleWhat they receive
pre-COVID-19 periodPatients hospitalized between 1.3.2019 and 28.02.2020
per-COVID-19 periodPatients hospitalized between 1.3.2020 and 28.02.2022
post-COVID-19 periodPatients hospitalized between 1.3.2022 and 28.02.2023

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intra-hospital mortality

    death during hospitalization of each patient

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

  2. composite outcome (worsening during hospitalization)

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

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

Secondary outcomes (66)

  1. Pathologies leading to hospitalization

    Primary and secondary diagnosis during hospitalization (CIM10 codes)

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

  2. overall mortality at 3 months (90 days)

    intra or extra hospital mortality : death occuring during hospitalization or after

    Measured: within the 3 months after the admission date

  3. Potentially avoidable readmission rate

    Potentially avoidable readmission according to SQLape algorithm (http://www.sqlape.com/READMISSIONS.htm)

    Measured: During the 30 days after the patient's discharge

  4. mortality rate by pathology at 3 months

    mortality for each top 10 of pathologies (intra or extra hospital mortality for each pathology)

    Measured: within the 3 months after the admission date

  5. length of stay

    Hospital length of stay (Time between admission date and discharge date)

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

  6. rate of transfer to intermediate or intensive care

    Number of patients with transfer to intensive or intermediate care during hospitalization

    Measured: At the discharge date, up to 3 months after admission

  7. rate of transfer to rehabilitation care

    Number of patients with rehabilitation transfer during hospitalization

    Measured: At the discharge date of acute care, up to 3 months after admission

  8. specific gravity outcomes for patients with pneumonia : CURB 65 scale (Confusion, Urea, Respiratory rate, Blood pressure, Age [>65])

    CURB65 scale: min-max 0 to 5 points [5 points : worse outcome]

    Measured: At the acute care admission

  9. specific gravity outcomes for patients with cardiac Failure : KILLIP class

    KILLIP class (class 1 to 4) [class 4 : worse outcome]. The KILLIP classification is a system used in individuals with an acute myocardial infarction (heart attack), taking into account physical examination and the development of heart failure in order to predict and stratify their risk of mortality.

    Measured: At the acute care admission

  10. specific gravity outcomes for patients with cardiac Failure : Weight variation

    Weight variation : variation of weight at the admission compared to the basis weight

    Measured: At the acute care admission

  11. specific gravity outcomes for patients with cardiac Failure or lung disease

    FIO2 (% O2 prescribed): Fraction of inspired oxygen

    Measured: At the acute care admission

  12. Leukocytes serum level

    Giga / litre

    Measured: At the acute care admission

  13. Polynuclear neutrophils serum level

    Giga / litre

    Measured: At the acute care admission

  14. Lymphocytes serum level

    Giga / litre

    Measured: At the acute care admission

  15. Hemoglobin serum level

    gram/litre

    Measured: At the acute care admission

  16. Thrombocytes serum level

    Giga / litre

    Measured: At the acute care admission

  17. Quick serum level

    in %

    Measured: At the acute care admission

  18. INR (International Normalized Ratio)

    No unit

    Measured: At the acute care admission

  19. fibrinogen serum level

    gram/litre

    Measured: At the acute care admission

  20. PTT serum level (partial Thromboplastin time)

    in second

    Measured: At the acute care admission

  21. D-Dimers serum level

    ng / ml

    Measured: At the acute care admission

  22. glucose serum level

    mmol / litre

    Measured: At the acute care admission

  23. glycated hemoglobin serum level (HbA1C)

    in %

    Measured: At the acute care admission

  24. C-reactive protein serum level (CRP)

    mg / litre

    Measured: At the acute care admission

  25. sodium serum level

    mmol / l

    Measured: At the acute care admission

  26. potassium serum level

    mmol / l

    Measured: At the acute care admission

  27. chlorides serum level

    mmol / l

    Measured: At the acute care admission

  28. calculated osmolality serum level

    mOsm / kg

    Measured: At the acute care admission

  29. Phosphates serum level

    mmol / l

    Measured: At the acute care admission

  30. corrected calcium serum level

    mmol / l

    Measured: At the acute care admission

  31. urea serum level

    mmol / l

    Measured: At the acute care admission

  32. creatinine serum level

    µmol / l

    Measured: At the acute care admission

  33. eGFR (CKD-EPI) serum level

    ml / min / 1.73m2

    Measured: At the acute care admission

  34. albumin serum level

    g / l

    Measured: At the acute care admission

  35. prealbumin serum level

    mg / l

    Measured: At the acute care admission

  36. cyanocobalamin serum level

    pmol / l

    Measured: At the acute care admission

  37. folate serum level

    nmol / l

    Measured: At the acute care admission

  38. 25-hydroxy vitamin D (D2 + D3) serum level

    nmol / l

    Measured: At the acute care admission

  39. proBNP (Brain Natriuretic Peptid) serum level

    ng / l

    Measured: At the acute care admission

  40. Ultra sensitive Troponin T serum level

    ng / l

    Measured: At the acute care admission

  41. ASAT (aspartate transaminase) serum level

    U / l

    Measured: At the acute care admission

  42. ALAT (alanine aminotransferase) serum level

    U / l

    Measured: At the acute care admission

  43. Alkaline phosphatases serum level

    U / l

    Measured: At the acute care admission

  44. Gamma glutamyl transpeptidase. serum level

    U / l

    Measured: At the acute care admission

  45. Total bilirubin serum level

    µmol / l

    Measured: At the acute care admission

  46. ferritin serum level

    µg / l

    Measured: At the acute care admission

  47. TSH serum level

    mU / l

    Measured: At the acute care admission

  48. Arterial pH

    No unit

    Measured: At the acute care admission

  49. Arterial pCO2 (carbon dioxide partial pressure)

    kPa

    Measured: At the acute care admission

  50. Arterial pO2 (oxygen partial pressure)

    kPa

    Measured: At the acute care admission

  51. Arterial lactate

    mmol / l

    Measured: At the acute care admission

  52. Arterial HCO3 (bicarbonate)

    mmol / l

    Measured: At the acute care admission

  53. protein serum level

    g / l

    Measured: At the acute care admission

  54. Arterial pressure

    Arterial pression (min-max), in mmHg

    Measured: At the acute care admission

  55. cardiac rates

    Bat/mn

    Measured: At the acute care admission

  56. respiratory rates

    /mn

    Measured: At the acute care admission

  57. temperature

    Celsius degrees

    Measured: At the acute care admission

  58. oxygen saturation

    Percutaneous oxygen saturation (in %)

    Measured: At the acute care admission

  59. peak flow

    L/mn

    Measured: At the acute care admission

  60. specific scales : VAS of pain

    Visual analog Pain scale (min-max : 1 to 10 [worse outcome])

    Measured: At the acute care admission

  61. specific scales : FIM

    Functional Independence Measure (min-max : 18 [worse outcome]) to 126)

    Measured: At the acute care admission

  62. specific scales : SOFA score

    Sequential Organ Failure Assessment Score (min-max : 0 to 24 [worse outcome])

    Measured: At the acute care admission

  63. specific scales : MNA

    Mini Nutritional Assessment (min-max : 0 [worse outcome] to 14)

    Measured: At the acute care admission

  64. specific scales : NRS

    Nutrition Risk Screening (min-max : 0 to 12 [worse outcome])

    Measured: At the acute care admission

  65. serum or urine positive bacteriologic sample

    number of positive hemoculture or urinary cultures

    Measured: At the acute care admission or during hospitalization

  66. Patient questionnaire

    Questionnaire asking each patient if they had difficulty seeing a doctor before their hospitalization and if they delayed their hospitalization due to the COVID-19 crisis.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2020
  2. Study start1 Mar 2019
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2023 (estimated)

Resources

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
Retrospective
Enrolment
240,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04537559
Sponsor's protocol ID
2020-01017
Acronym
NoCOVImpact
Status last verified
Mar 2022
First submitted
27 Aug 2020
Last updated
25 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32199938

  • 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.

    PubMed 32283124

  • 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.

    PubMed 32315205

  • 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.

    PubMed 32302076

  • 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.

    PubMed 6059183

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by University Hospital, Geneva 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Mar 2022. 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?

Results are not available in the source record.

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?

Intra-hospital mortality (time frame: Assessed at the discharge date, up to 3 months after admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04537559, which also lists 5 linked publications.

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 25 Mar 2022.

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