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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 576

Contacts and Locations

Study Locations

• Spain
  • Albacete, Spain, 02006
    • Complejo Hospitalario Universitario de Albacete

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality for all causes	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
X-ray changes	Changes from admission to discharge thorax X-rays assessed by blinded radiologists	1 month
Disability changes	Changes from admission to discharge in Barthel index	1 month
Ambulation changes	Changes from admission to discharge in Functional Ambulation Classification	1 month
lymphocyte count changes	Changes from admission to discharge in lymphocyte count	1 month
C-Reactive Protein changes	Changes from admission to discharge in C-Reactive Protein	1 month
Ferritin changes	Changes from admission to discharge in Ferritin	1 month
D-Dimer changes	Changes from admission to discharge in D-Dimer	1 month

Collaborators and Investigators

• Sponsor: Complejo Hospitalario Universitario de Albacete
• Investigators: Principal Investigator: Pedro Abizanda Soler, MD,PhD, Head Geriatrics Department

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 15, 2021

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Mortality; Older adults; Effectiveness; Hospitalization; Anakinra; Baricitinib; Security
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Antirheumatic Agents; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: PAS-BAR-2020-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Time Frame: At data Journal publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• 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