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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04362943
Acronym
COVID-AGE
Enrollment
576
Registered
2020-04-27
Start date
2020-04-20
Completion date
2021-04-15
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, Older adults, Hospitalization, Baricitinib, Anakinra, Effectiveness, Security, Mortality

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.

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.

Interventions

DRUGBaricitinib or Anakinra

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

Sponsors

Complejo Hospitalario Universitario de Albacete
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality1 monthMortality for all causes

Secondary

MeasureTime frameDescription
Disability changes1 monthChanges from admission to discharge in Barthel index
Ambulation changes1 monthChanges from admission to discharge in Functional Ambulation Classification
lymphocyte count changes1 monthChanges from admission to discharge in lymphocyte count
X-ray changes1 monthChanges from admission to discharge thorax X-rays assessed by blinded radiologists
Ferritin changes1 monthChanges from admission to discharge in Ferritin
D-Dimer changes1 monthChanges from admission to discharge in D-Dimer
C-Reactive Protein changes1 monthChanges from admission to discharge in C-Reactive Protein

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026