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.
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.
Drug: Baricitinib or Anakinra
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
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
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Pedro Abizanda Soler, MD,PhD, Principal Investigator
Head Geriatrics Department