Clinical trial NCT04362943: Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults
Official title: Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Older adults
Hospitalization
Baricitinib
Anakinra
Effectiveness
Security
Mortality
Lead sponsor: Complejo Hospitalario Universitario de Albacete
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 576
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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).

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.

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:

* None

Primary outcomes:
measure: Mortality
timeFrame: 1 month
Secondary outcomes:
measure: X-ray changes
timeFrame: 1 month
measure: Disability changes
timeFrame: 1 month
measure: Ambulation changes
timeFrame: 1 month
measure: lymphocyte count changes
timeFrame: 1 month
measure: C-Reactive Protein changes
timeFrame: 1 month
measure: Ferritin changes
timeFrame: 1 month
measure: D-Dimer changes
timeFrame: 1 month
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
Study officials:
affiliation: Head Geriatrics Department
name: Pedro Abizanda Soler, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: