Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults
NCT ID: NCT04362943
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
576 participants
OBSERVATIONAL
2020-04-20
2021-04-15
Brief Summary
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Detailed Description
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Measurements:
* Age, sex, residency.
* Functional assessment: Barthel index, Katz index, Functional Ambulation Classification.
* Cognitive assessment: Reisberg´s Global Deteriorating Scale.
* Comorbidity: Charlson index, disease count.
* Chronic medicines consumed.
* Disease related symptoms.
* Lab determinations: White cells, neutrophyl count, lymphocyte count, platelets, haemoglobin, INR, fibrinogen, D-Dimer, Ferritin, CRP, IL-6, urea, creatinin, AST, ALT, CK.
* Thorax X-ray findings: COVID affectation, severity, pleural effusion, heart failure signs, pneumothorax.
* Drugs used during hospitalization, number of days of treatment and total doses: Anakinra, Baricitinib, Glucocorticoids, Antivirals (Lopinavir/Ritonavir, Emtricitabina/Tenofovir), Azitromycin, Ceftriaxone, Hidroxychloroquin.
* Geriatric syndroms: Delirium, immobility, dysphagia, pressure ulcers.
* Outcomes: Mortality at discharge, institucionalización at discharge, length of stay, change in lab results, change in X-ray results, change in function at discharge.
Registry procedures: Medical chart review by trained Geriatricians, pharmachological chart review by expert Pharmacists, X-ray review by trained radiologists. All data will be included in an anonimyzed database for further analysis by investigators, and supervised by Principal Investigator.
Regulatory status: The protocol was approved by the Ethics review committee of Albacete (number 2020-21 from 20/04/2020) and by the Spanish Medicines Agency (AEMPS) who gave a "Postauthorization Study" classification (number PAS-BAR-2020-04. 20/04/2020).
Analysis: Two stage analysis will be conducted. In first one, efficacy and security analysis of the 99 patients that have received either Baricitinib or Anakinra will be conducted, and in the second one, clinical-epidemiological analysis of the complete sample, n=576, will be realized.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Complete sample
Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 in the "Perpetuo Socorro" Hospital of Albacete (Spain)
Baricitinib or Anakinra
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
Baricitinib
Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Baricitinib.
Baricitinib or Anakinra
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
Anakinra
Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Anakinra.
Baricitinib or Anakinra
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
Interventions
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Baricitinib or Anakinra
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
70 Years
ALL
No
Sponsors
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Complejo Hospitalario Universitario de Albacete
OTHER
Responsible Party
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Pedro Abizanda
Prof.
Principal Investigators
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Pedro Abizanda Soler, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Head Geriatrics Department
Locations
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Complejo Hospitalario Universitario de Albacete
Albacete, , Spain
Countries
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Other Identifiers
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PAS-BAR-2020-04
Identifier Type: -
Identifier Source: org_study_id
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