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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Baricitinib or Anakinra


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complete sample<br>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) | Drug: Baricitinib or Anakinra<br>* Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.<br>|
| Baricitinib<br>Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Baricitinib. | Drug: Baricitinib or Anakinra<br>* Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.<br>|
| Anakinra<br>Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Anakinra. | Drug: Baricitinib or Anakinra<br>* Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality for all causes | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Older adults, Hospitalization, Baricitinib, Anakinra, Effectiveness, Security, Mortality