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Clinical Trials/NCT04362943
NCT04362943
Completed
Not Applicable

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

Complejo Hospitalario Universitario de Albacete1 site in 1 country576 target enrollmentApril 20, 2020

Overview

Phase
Not Applicable
Intervention
Baricitinib or Anakinra
Conditions
COVID-19
Sponsor
Complejo Hospitalario Universitario de Albacete
Enrollment
576
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2020
End Date
April 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Complejo Hospitalario Universitario de Albacete
Responsible Party
Principal Investigator
Principal Investigator

Pedro Abizanda

Prof.

Complejo Hospitalario Universitario de Albacete

Eligibility 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

  • Not provided

Arms & Interventions

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)

Intervention: Baricitinib or Anakinra

Baricitinib

Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Baricitinib.

Intervention: Baricitinib or Anakinra

Anakinra

Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Anakinra.

Intervention: Baricitinib or Anakinra

Outcomes

Primary Outcomes

Mortality

Time Frame: 1 month

Mortality for all causes

Secondary Outcomes

  • Disability changes(1 month)
  • lymphocyte count changes(1 month)
  • C-Reactive Protein changes(1 month)
  • Ferritin changes(1 month)
  • Ambulation changes(1 month)
  • D-Dimer changes(1 month)
  • X-ray changes(1 month)

Study Sites (1)

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