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

Completed

• Conditions: COVID-19
• Interventions: Drug: Baricitinib or Anakinra

• Registration Number: NCT04362943
• Lead Sponsor: Complejo Hospitalario Universitario de Albacete

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.

Study Timeline

• Study Start: 2020-04-20
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Baricitinib	Baricitinib or Anakinra	Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Baricitinib.
Anakinra	Baricitinib or Anakinra	Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Anakinra.
Complete sample	Baricitinib or Anakinra	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)

Primary Outcome Measures

Name	Time	Method
Mortality	1 month	Mortality for all causes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Complejo Hospitalario Universitario de Albacete; 🇪🇸 Albacete, Spain