An observational study in COVID-19, sponsored by Complejo Hospitalario Universitario de Albacete. Completed at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Complejo Hospitalario Universitario de Albacete · Observational
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:
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 576 is above the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →Complejo Hospitalario Universitario de Albacete is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion 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)
Drug: Baricitinib or Anakinra
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
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
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
Mortality
Mortality for all causes
Time frame: 1 month
X-ray changes
Changes from admission to discharge thorax X-rays assessed by blinded radiologists
Time frame: 1 month
Disability changes
Changes from admission to discharge in Barthel index
Time frame: 1 month
Ambulation changes
Changes from admission to discharge in Functional Ambulation Classification
Time frame: 1 month
lymphocyte count changes
Changes from admission to discharge in lymphocyte count
Time frame: 1 month
C-Reactive Protein changes
Changes from admission to discharge in C-Reactive Protein
Time frame: 1 month
Ferritin changes
Changes from admission to discharge in Ferritin
Time frame: 1 month
D-Dimer changes
Changes from admission to discharge in D-Dimer
Time frame: 1 month
Plan to share: Yes — Data will be shared on request. Study protocol, statistical analysis and clinical study report will be shared when data will be published in a Journal.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: At data Journal publication
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Complejo Hospitalario Universitario de Albacete