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