Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04362943 |
| Other study ID # |
PAS-BAR-2020-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2020 |
| Est. completion date |
April 15, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Complejo Hospitalario Universitario de Albacete |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
