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

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ClinicalTrials.gov Identifier: NCT04362943
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Pedro Abizanda, Complejo Hospitalario Universitario de Albacete

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
COVID-19 Drug: Baricitinib or Anakinra

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 576 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Groups and Cohorts
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Group/Cohort Intervention/treatment
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)
 Drug: 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.
 Drug: 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.
 Drug: Baricitinib or Anakinra
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 month ]
    Mortality for all causes


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362943


Contacts
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Contact: Pedro Abizanda Soler, MD,PhD +34636557437 pabizanda@sescam.jccm.es
Contact: Almudena Avendaño Céspedes, RN, PhD +34967597684 aavendanoc@sescam.jccm.es

Locations
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Spain
Complejo Hospitalario Universitario de Albacete Recruiting
Albacete, Spain, 02006
Contact: Pedro Abizanda Soler, MD,PhD    +34967597684    pabizanda@sescam.jccm.es   
Contact: Almudena Avendaño Céspedes, RN, PhD    +34967597684    aavendanoc@sescam.jccm.es   
Sponsors and Collaborators
Complejo Hospitalario Universitario de Albacete
Investigators
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Principal Investigator: Pedro Abizanda Soler, MD,PhD Head Geriatrics Department
More Information
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Responsible Party: Pedro Abizanda, Prof., Complejo Hospitalario Universitario de Albacete
ClinicalTrials.gov Identifier: NCT04362943    
Other Study ID Numbers: PAS-BAR-2020-04
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared on request. Study protocol, statistical analysis and clinical study report will be shared when data will be published in a Journal.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: At data Journal publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pedro Abizanda, Complejo Hospitalario Universitario de Albacete:
COVID-19
Older adults
Hospitalization
Baricitinib
 Anakinra
Effectiveness
Security
Mortality
Additional relevant MeSH terms:
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Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents