Complejo Hospitalario Universitario de Albacete
Albacete, 02006, Spain
NCT Number: NCT04362943
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.
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Notify Me70 year and older
All sexes
Observational
Albacete, 02006, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
Time frame: 1 month
Mortality for all causes
Time frame: 1 month
Changes from admission to discharge thorax X-rays assessed by blinded radiologists
Time frame: 1 month
Changes from admission to discharge in Barthel index
Time frame: 1 month
Changes from admission to discharge in Functional Ambulation Classification
Time frame: 1 month
Changes from admission to discharge in lymphocyte count
Time frame: 1 month
Changes from admission to discharge in C-Reactive Protein
Time frame: 1 month
Changes from admission to discharge in Ferritin
Time frame: 1 month
Changes from admission to discharge in D-Dimer
Complejo Hospitalario Universitario de Albacete
Other
Acronym: COVID-AGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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