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NCT Number: NCT04362943

Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults

Retrospective clinical-epidemiological study aimed at characterizing COVID-19 disease in adults older than 70 years, hospitalized in the "Perpetuo Socorro" Hospital of Albacete (Spain) from 09/03/2020 until 20/04/2020. Secondary objectives will be to analyze clinical-epidemiological characteristics of COVID-19 patients treated with Baricitinib or Anakinra, and to describe the efficacy and secondary effects of those drugs.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

About this study

Design: Retrospective postauthorization study. Registry study. Setting: COVID Unit, "Perpetuo Socorro" Hospital of Albacete (Spain). Participants: Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020. All patients will be included without exclussion criteria.

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • None

Treatment and study plan

Baricitinib or Anakinra

Drug

Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.

Primary outcomes

  1. Mortality

    Time frame: 1 month

    Mortality for all causes

Secondary outcomes

  1. X-ray changes

    Time frame: 1 month

    Changes from admission to discharge thorax X-rays assessed by blinded radiologists

  2. Disability changes

    Time frame: 1 month

    Changes from admission to discharge in Barthel index

  3. Ambulation changes

    Time frame: 1 month

    Changes from admission to discharge in Functional Ambulation Classification

  4. lymphocyte count changes

    Time frame: 1 month

    Changes from admission to discharge in lymphocyte count

  5. C-Reactive Protein changes

    Time frame: 1 month

    Changes from admission to discharge in C-Reactive Protein

  6. Ferritin changes

    Time frame: 1 month

    Changes from admission to discharge in Ferritin

  7. D-Dimer changes

    Time frame: 1 month

    Changes from admission to discharge in D-Dimer

Sponsors and collaborators

Lead sponsor

Complejo Hospitalario Universitario de Albacete

Other

Registry information

Acronym: COVID-AGE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2020
Registry last updated
Jul 28, 2021

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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