Covid19NCT04499300
Elderly Patients and COVID-19 Infection: a Cohort of Fifty Patients Over Ninety Years of Age
An observational study of Covid19, run by Murielle Surquin at 1 site in Belgium.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 90 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Data collection from medical files
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jun 2020to 23 Nov 2020
- 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 90 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Same as inclusion criteria
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Covid19
- Being tested
- Data collection from medical files
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection from medical filesOther
Data collection from medical files
| Study group | Role | What they receive |
|---|---|---|
| Covid positive | Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection. Receives: Other: 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. Receives: Other: 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. Receives: Other: Data collection from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Age, sex, ethnicity
Measured: 5 minutes
Comorbidities
Smoking, Obesity, Diabetes, Arterial hypertension, Coronary pathology, Cerebrovascular disease, chronic renal failure, chronic obstructive pulmonary disease, Neoplasia, Autoimmune disease, Chronic liver disease
Measured: 5 minutes
Cumulative Illness Rating Scale-Geriatric (CIRS-G)
CIRS-G quantifies burden of disease in elderly patients (comorbidity scale). Higher scores indicate higher severity (maximum score = 56 points).
Measured: 5 minutes
Treatments
Under Chronic corticosteroid therapy or Immunosuppressive therapy
Measured: 5 minutes
Signs and symptoms
Presence and date of first apparition: Fever, Cough, Dyspnea, Chest pain, Nausea or vomiting, Diarrhea, Fatigue, Anosmia, ageusia, inappetence, Confusion, Fall, Fracture
Measured: 5 minutes
Fever
Vital signs at hospital admission: Fever
Measured: 5 minutes
Hypoxemia
Vital signs at hospital admission: Hypoxemia
Measured: 5 minutes
Tachycardia
Vital signs at hospital admission:Tachycardia
Measured: 5 minutes
Hypotension
Vital signs at hospital admission: Hypotension
Measured: 5 minutes
Gasometry
Vital signs at hospital admission: Gasometry
Measured: 5 minutes
Infectious data
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
Measured: 5 minutes
Blood count
Blood count at hospital admission or first recorded
Measured: 5 minutes
Ionogram
Ionogram at hospital admission or first recorded
Measured: 5 minutes
Liver function
Liver function at hospital admission or first recorded
Measured: 5 minutes
Coagulation
Coagulation at hospital admission or first recorded
Measured: 5 minutes
Renal function
Renal function at hospital admission or first recorded
Measured: 5 minutes
Albumin
Albumin at hospital admission or first recorded
Measured: 5 minutes
CRP
CRP at hospital admission or first recorded
Measured: 5 minutes
Fibrinogen
Fibrinogen at hospital admission or first recorded
Measured: 5 minutes
D-dimers at hospital admission or first recorded
D-dimers
Measured: 5 minutes
NTproBNP
NTproBNP at hospital admission or first recorded
Measured: 5 minutes
CK
CK at hospital admission or first recorded
Measured: 5 minutes
Troponin
Troponin at hospital admission or first recorded
Measured: 5 minutes
Ferritin
Ferritin at hospital admission or first recorded
Measured: 5 minutes
Procalcitonin
Procalcitonin at hospital admission or first recorded
Measured: 5 minutes
Biology - highest rate
Highest rate of CRP, D-Dimers, Urea, Creatinin, Fibrinogen, CK, Troponins
Measured: 5 minutes
Biology - lowest rate
Lowest rate of hemoglobin, platelets, leucocytes, lymphocytes, albumin, Na+, K+
Measured: 5 minutes
Percentage of pulmonary involvement on chest CT scan
Percentage of pulmonary involvement on chest CT scan
Measured: 5 minutes
Number of pulmonary lobes affected
Number of pulmonary lobes affected
Measured: 5 minutes
Type of lesions
Type of lesions as reflected on the CT scan images: 'Ground glass' or 'Crazy paving'
Measured: 5 minutes
Need for oxygenotherapy
Need for oxygenotherapy (yes/no)
Measured: 5 minutes
Means of ventilation
Means of ventilation
Measured: 5 minutes
Treatment received
Hydroxychloroquine or Azithromycin
Measured: 5 minutes
Length of ICU Stay
Length of ICU Stay
Measured: 5 minutes
Status at hospital exit
One of the following choices: death, went back home, went back to a retirement home, was placed in a revalidation unit.
Measured: 5 minutes
Mortality
28-day mortality after PCR / CT scan / diagnosis
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start9 Jun 2020
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murielle Surquin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murielle Surquin, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499300
- Sponsor's protocol ID
- CHUB-COVID-19-90+
- Status last verified
- Mar 2022
- First submitted
- 3 Aug 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly Patients and COVID-19 Infection: a Cohort of Fifty Patients Over Ninety Years of Age
- ClinicalTrials.gov ID
- NCT04499300
- Acronym / sponsor ID
- CHUB-COVID-19-90+
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Murielle SurquinUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Covid positive | – | Other: Data collection from medical filesPatients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection. |
| Sub-group: deceased patients | – | Other: Data collection from medical filesPatients 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. |
| Sub-group: patients who survived | – | Other: Data collection from medical filesPatients 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. |
Who may qualify
- Ages
- 90 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Same as inclusion criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection from medical filesData collection from medical files | Other | Covid positive, Sub-group: deceased patients, Sub-group: patients who survived |
Primary outcome
Demographic data
Time frame: 5 minutes
Age, sex, ethnicity
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
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).
Treatments
Time frame: 5 minutes
Under Chronic corticosteroid therapy or Immunosuppressive therapy
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
Fever
Time frame: 5 minutes
Vital signs at hospital admission: Fever
Hypoxemia
Time frame: 5 minutes
Vital signs at hospital admission: Hypoxemia
Tachycardia
Time frame: 5 minutes
Vital signs at hospital admission:Tachycardia
Hypotension
Time frame: 5 minutes
Vital signs at hospital admission: Hypotension
Gasometry
Time frame: 5 minutes
Vital signs at hospital admission: Gasometry
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
Blood count
Time frame: 5 minutes
Blood count at hospital admission or first recorded
Ionogram
Time frame: 5 minutes
Ionogram at hospital admission or first recorded
Liver function
Time frame: 5 minutes
Liver function at hospital admission or first recorded
Coagulation
Time frame: 5 minutes
Coagulation at hospital admission or first recorded
Renal function
Time frame: 5 minutes
Renal function at hospital admission or first recorded
Albumin
Time frame: 5 minutes
Albumin at hospital admission or first recorded
CRP
Time frame: 5 minutes
CRP at hospital admission or first recorded
Fibrinogen
Time frame: 5 minutes
Fibrinogen at hospital admission or first recorded
D-dimers at hospital admission or first recorded
Time frame: 5 minutes
D-dimers
NTproBNP
Time frame: 5 minutes
NTproBNP at hospital admission or first recorded
CK
Time frame: 5 minutes
CK at hospital admission or first recorded
Troponin
Time frame: 5 minutes
Troponin at hospital admission or first recorded
Ferritin
Time frame: 5 minutes
Ferritin at hospital admission or first recorded
Procalcitonin
Time frame: 5 minutes
Procalcitonin at hospital admission or first recorded
Biology - highest rate
Time frame: 5 minutes
Highest rate of CRP, D-Dimers, Urea, Creatinin, Fibrinogen, CK, Troponins
Biology - lowest rate
Time frame: 5 minutes
Lowest rate of hemoglobin, platelets, leucocytes, lymphocytes, albumin, Na+, K+
Percentage of pulmonary involvement on chest CT scan
Time frame: 5 minutes
Percentage of pulmonary involvement on chest CT scan
Number of pulmonary lobes affected
Time frame: 5 minutes
Number of pulmonary lobes affected
Type of lesions
Time frame: 5 minutes
Type of lesions as reflected on the CT scan images: 'Ground glass' or 'Crazy paving'
Need for oxygenotherapy
Time frame: 5 minutes
Need for oxygenotherapy (yes/no)
Means of ventilation
Time frame: 5 minutes
Means of ventilation
Treatment received
Time frame: 5 minutes
Hydroxychloroquine or Azithromycin
Length of ICU Stay
Time frame: 5 minutes
Length of ICU Stay
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.
Mortality
Time frame: 5 minutes
28-day mortality after PCR / CT scan / diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Murielle Surquin at 1 site in Belgium.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 29 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demographic data (time frame: 5 minutes). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2022.