- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04499300
Elderly Patients and COVID-19 Infection: a Cohort of Fifty Patients Over Ninety Years of Age
SARS-CoV2 or CoVid19 disease is a newly described pathology linked to a subtype of the coronavirus family identified in China in December 2019. This pathology can present multiple clinical facets, ranging from asymptomatic forms to more commonly critical pulmonary forms called "Acute Respiratory Distress Syndrome". The elderly population is more at risk for this infection due to the senescence of the immune system, co-morbidities and poly medications. They also often present a greater state of fragility.
This study aims to report the epidemiology of the first 50 patients over 90 years of age hospitalized within the CHU Brugmann hospital.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium
- CHU Brugmann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Be over 90 years of age on the date of admission to CHU Brugmann Hospital
- Have a SARS Cov2 infection proven by antigen or RT-PCR on smear and / or typical imaging regardless of the clinical manifestation
- Have been hospitalized at CHU Brugmann between 03/01/2020 and 05/10/2020
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Covid positive
Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection.
|
Data collection from medical files
|
|
Sub-group: deceased patients
Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection, with death as outcome.
|
Data collection from medical files
|
|
Sub-group: patients who survived
Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection, who survived the infection.
|
Data collection from medical files
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic data
Time Frame: 5 minutes
|
Age, sex, ethnicity
|
5 minutes
|
|
Comorbidities
Time Frame: 5 minutes
|
Smoking, Obesity, Diabetes, Arterial hypertension, Coronary pathology, Cerebrovascular disease, chronic renal failure, chronic obstructive pulmonary disease, Neoplasia, Autoimmune disease, Chronic liver disease
|
5 minutes
|
|
Cumulative Illness Rating Scale-Geriatric (CIRS-G)
Time Frame: 5 minutes
|
CIRS-G quantifies burden of disease in elderly patients (comorbidity scale).
Higher scores indicate higher severity (maximum score = 56 points).
|
5 minutes
|
|
Treatments
Time Frame: 5 minutes
|
Under Chronic corticosteroid therapy or Immunosuppressive therapy
|
5 minutes
|
|
Signs and symptoms
Time Frame: 5 minutes
|
Presence and date of first apparition: Fever, Cough, Dyspnea, Chest pain, Nausea or vomiting, Diarrhea, Fatigue, Anosmia, ageusia, inappetence, Confusion, Fall, Fracture
|
5 minutes
|
|
Fever
Time Frame: 5 minutes
|
Vital signs at hospital admission: Fever
|
5 minutes
|
|
Hypoxemia
Time Frame: 5 minutes
|
Vital signs at hospital admission: Hypoxemia
|
5 minutes
|
|
Tachycardia
Time Frame: 5 minutes
|
Vital signs at hospital admission:Tachycardia
|
5 minutes
|
|
Hypotension
Time Frame: 5 minutes
|
Vital signs at hospital admission: Hypotension
|
5 minutes
|
|
Gasometry
Time Frame: 5 minutes
|
Vital signs at hospital admission: Gasometry
|
5 minutes
|
|
Infectious data
Time Frame: 5 minutes
|
Contact with confirmed covid person before admission, lives in a retirement home with other cases, Initial bacterial or viral co-infection, Bacterial or viral co-infection during the hospital stay
|
5 minutes
|
|
Blood count
Time Frame: 5 minutes
|
Blood count at hospital admission or first recorded
|
5 minutes
|
|
Ionogram
Time Frame: 5 minutes
|
Ionogram at hospital admission or first recorded
|
5 minutes
|
|
Liver function
Time Frame: 5 minutes
|
Liver function at hospital admission or first recorded
|
5 minutes
|
|
Coagulation
Time Frame: 5 minutes
|
Coagulation at hospital admission or first recorded
|
5 minutes
|
|
Renal function
Time Frame: 5 minutes
|
Renal function at hospital admission or first recorded
|
5 minutes
|
|
Albumin
Time Frame: 5 minutes
|
Albumin at hospital admission or first recorded
|
5 minutes
|
|
CRP
Time Frame: 5 minutes
|
CRP at hospital admission or first recorded
|
5 minutes
|
|
Fibrinogen
Time Frame: 5 minutes
|
Fibrinogen at hospital admission or first recorded
|
5 minutes
|
|
D-dimers at hospital admission or first recorded
Time Frame: 5 minutes
|
D-dimers
|
5 minutes
|
|
NTproBNP
Time Frame: 5 minutes
|
NTproBNP at hospital admission or first recorded
|
5 minutes
|
|
CK
Time Frame: 5 minutes
|
CK at hospital admission or first recorded
|
5 minutes
|
|
Troponin
Time Frame: 5 minutes
|
Troponin at hospital admission or first recorded
|
5 minutes
|
|
Ferritin
Time Frame: 5 minutes
|
Ferritin at hospital admission or first recorded
|
5 minutes
|
|
Procalcitonin
Time Frame: 5 minutes
|
Procalcitonin at hospital admission or first recorded
|
5 minutes
|
|
Biology - highest rate
Time Frame: 5 minutes
|
Highest rate of CRP, D-Dimers, Urea, Creatinin, Fibrinogen, CK, Troponins
|
5 minutes
|
|
Biology - lowest rate
Time Frame: 5 minutes
|
Lowest rate of hemoglobin, platelets, leucocytes, lymphocytes, albumin, Na+, K+
|
5 minutes
|
|
Percentage of pulmonary involvement on chest CT scan
Time Frame: 5 minutes
|
Percentage of pulmonary involvement on chest CT scan
|
5 minutes
|
|
Number of pulmonary lobes affected
Time Frame: 5 minutes
|
Number of pulmonary lobes affected
|
5 minutes
|
|
Type of lesions
Time Frame: 5 minutes
|
Type of lesions as reflected on the CT scan images: 'Ground glass' or 'Crazy paving'
|
5 minutes
|
|
Need for oxygenotherapy
Time Frame: 5 minutes
|
Need for oxygenotherapy (yes/no)
|
5 minutes
|
|
Means of ventilation
Time Frame: 5 minutes
|
Means of ventilation
|
5 minutes
|
|
Treatment received
Time Frame: 5 minutes
|
Hydroxychloroquine or Azithromycin
|
5 minutes
|
|
Length of ICU Stay
Time Frame: 5 minutes
|
Length of ICU Stay
|
5 minutes
|
|
Status at hospital exit
Time Frame: 5 minutes
|
One of the following choices: death, went back home, went back to a retirement home, was placed in a revalidation unit.
|
5 minutes
|
|
Mortality
Time Frame: 5 minutes
|
28-day mortality after PCR / CT scan / diagnosis
|
5 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-COVID-19-90+
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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