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OpenTrials
Completed

NCT Number: 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

90 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collection from medical files

Other

Data collection from medical files

Primary outcomes

  1. Demographic data

    Time frame: 5 minutes

    Age, sex, ethnicity

  2. 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

  3. 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).

  4. Treatments

    Time frame: 5 minutes

    Under Chronic corticosteroid therapy or Immunosuppressive therapy

  5. 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

  6. Fever

    Time frame: 5 minutes

    Vital signs at hospital admission: Fever

  7. Hypoxemia

    Time frame: 5 minutes

    Vital signs at hospital admission: Hypoxemia

  8. Tachycardia

    Time frame: 5 minutes

    Vital signs at hospital admission:Tachycardia

  9. Hypotension

    Time frame: 5 minutes

    Vital signs at hospital admission: Hypotension

  10. Gasometry

    Time frame: 5 minutes

    Vital signs at hospital admission: Gasometry

  11. 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

  12. Blood count

    Time frame: 5 minutes

    Blood count at hospital admission or first recorded

  13. Ionogram

    Time frame: 5 minutes

    Ionogram at hospital admission or first recorded

  14. Liver function

    Time frame: 5 minutes

    Liver function at hospital admission or first recorded

  15. Coagulation

    Time frame: 5 minutes

    Coagulation at hospital admission or first recorded

  16. Renal function

    Time frame: 5 minutes

    Renal function at hospital admission or first recorded

  17. Albumin

    Time frame: 5 minutes

    Albumin at hospital admission or first recorded

  18. CRP

    Time frame: 5 minutes

    CRP at hospital admission or first recorded

  19. Fibrinogen

    Time frame: 5 minutes

    Fibrinogen at hospital admission or first recorded

  20. D-dimers at hospital admission or first recorded

    Time frame: 5 minutes

    D-dimers

  21. NTproBNP

    Time frame: 5 minutes

    NTproBNP at hospital admission or first recorded

  22. CK

    Time frame: 5 minutes

    CK at hospital admission or first recorded

  23. Troponin

    Time frame: 5 minutes

    Troponin at hospital admission or first recorded

  24. Ferritin

    Time frame: 5 minutes

    Ferritin at hospital admission or first recorded

  25. Procalcitonin

    Time frame: 5 minutes

    Procalcitonin at hospital admission or first recorded

  26. Biology - highest rate

    Time frame: 5 minutes

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

  27. Biology - lowest rate

    Time frame: 5 minutes

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

  28. Percentage of pulmonary involvement on chest CT scan

    Time frame: 5 minutes

    Percentage of pulmonary involvement on chest CT scan

  29. Number of pulmonary lobes affected

    Time frame: 5 minutes

    Number of pulmonary lobes affected

  30. Type of lesions

    Time frame: 5 minutes

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

  31. Need for oxygenotherapy

    Time frame: 5 minutes

    Need for oxygenotherapy (yes/no)

  32. Means of ventilation

    Time frame: 5 minutes

    Means of ventilation

  33. Treatment received

    Time frame: 5 minutes

    Hydroxychloroquine or Azithromycin

  34. Length of ICU Stay

    Time frame: 5 minutes

    Length of ICU Stay

  35. 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.

  36. Mortality

    Time frame: 5 minutes

    28-day mortality after PCR / CT scan / diagnosis

Sponsors and collaborators

Lead sponsor

Murielle Surquin

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2020
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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