NCT04499300

Brief 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". 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

June 9, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

August 3, 2020

Last Update Submit

March 28, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (36)

  • Demographic data

    Age, sex, ethnicity

    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

    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).

    5 minutes

  • Treatments

    Under Chronic corticosteroid therapy or Immunosuppressive therapy

    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

    5 minutes

  • Fever

    Vital signs at hospital admission: Fever

    5 minutes

  • Hypoxemia

    Vital signs at hospital admission: Hypoxemia

    5 minutes

  • Tachycardia

    Vital signs at hospital admission:Tachycardia

    5 minutes

  • Hypotension

    Vital signs at hospital admission: Hypotension

    5 minutes

  • Gasometry

    Vital signs at hospital admission: Gasometry

    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

    5 minutes

  • Blood count

    Blood count at hospital admission or first recorded

    5 minutes

  • Ionogram

    Ionogram at hospital admission or first recorded

    5 minutes

  • Liver function

    Liver function at hospital admission or first recorded

    5 minutes

  • Coagulation

    Coagulation at hospital admission or first recorded

    5 minutes

  • Renal function

    Renal function at hospital admission or first recorded

    5 minutes

  • Albumin

    Albumin at hospital admission or first recorded

    5 minutes

  • CRP

    CRP at hospital admission or first recorded

    5 minutes

  • Fibrinogen

    Fibrinogen at hospital admission or first recorded

    5 minutes

  • D-dimers at hospital admission or first recorded

    D-dimers

    5 minutes

  • NTproBNP

    NTproBNP at hospital admission or first recorded

    5 minutes

  • CK

    CK at hospital admission or first recorded

    5 minutes

  • Troponin

    Troponin at hospital admission or first recorded

    5 minutes

  • Ferritin

    Ferritin at hospital admission or first recorded

    5 minutes

  • Procalcitonin

    Procalcitonin at hospital admission or first recorded

    5 minutes

  • Biology - highest rate

    Highest rate of CRP, D-Dimers, Urea, Creatinin, Fibrinogen, CK, Troponins

    5 minutes

  • Biology - lowest rate

    Lowest rate of hemoglobin, platelets, leucocytes, lymphocytes, albumin, Na+, K+

    5 minutes

  • Percentage of pulmonary involvement on chest CT scan

    Percentage of pulmonary involvement on chest CT scan

    5 minutes

  • Number of pulmonary lobes affected

    Number of pulmonary lobes affected

    5 minutes

  • Type of lesions

    Type of lesions as reflected on the CT scan images: 'Ground glass' or 'Crazy paving'

    5 minutes

  • Need for oxygenotherapy

    Need for oxygenotherapy (yes/no)

    5 minutes

  • Means of ventilation

    Means of ventilation

    5 minutes

  • Treatment received

    Hydroxychloroquine or Azithromycin

    5 minutes

  • Length of ICU Stay

    Length of ICU Stay

    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.

    5 minutes

  • Mortality

    28-day mortality after PCR / CT scan / diagnosis

    5 minutes

Study Arms (3)

Covid positive

Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection.

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.

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.

Other: Data collection from medical files

Interventions

Data collection from medical filesOTHER

Data collection from medical files

Covid positiveSub-group: deceased patientsSub-group: patients who survived

Eligibility Criteria

Age90 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Same as inclusion criteria

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, Belgium

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of geriatry department

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 5, 2020

Study Start

June 9, 2020

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)