Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults (COVID-AGE)
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ClinicalTrials.gov Identifier: NCT04362943 |
Recruitment Status :
Recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
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Condition or disease | Intervention/treatment |
---|---|
COVID-19 | Drug: Baricitinib or Anakinra |
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 Type : | Observational |
Estimated Enrollment : | 576 participants |
Observational Model: | Other |
Time Perspective: | Retrospective |
Official Title: | Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults |
Actual Study Start Date : | April 20, 2020 |
Estimated Primary Completion Date : | May 15, 2020 |
Estimated Study Completion Date : | July 31, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Complete sample
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
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care. |
Baricitinib
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
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care. |
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 [ Time Frame: 1 month ]Mortality for all causes
- X-ray changes [ Time Frame: 1 month ]Changes from admission to discharge thorax X-rays assessed by blinded radiologists
- Disability changes [ Time Frame: 1 month ]Changes from admission to discharge in Barthel index
- Ambulation changes [ Time Frame: 1 month ]Changes from admission to discharge in Functional Ambulation Classification
- lymphocyte count changes [ Time Frame: 1 month ]Changes from admission to discharge in lymphocyte count
- C-Reactive Protein changes [ Time Frame: 1 month ]Changes from admission to discharge in C-Reactive Protein
- Ferritin changes [ Time Frame: 1 month ]Changes from admission to discharge in Ferritin
- D-Dimer changes [ Time Frame: 1 month ]Changes from admission to discharge in D-Dimer

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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362943
Contact: Pedro Abizanda Soler, MD,PhD | +34636557437 | pabizanda@sescam.jccm.es | |
Contact: Almudena Avendaño Céspedes, RN, PhD | +34967597684 | aavendanoc@sescam.jccm.es |
Spain | |
Complejo Hospitalario Universitario de Albacete | Recruiting |
Albacete, Spain, 02006 | |
Contact: Pedro Abizanda Soler, MD,PhD +34967597684 pabizanda@sescam.jccm.es | |
Contact: Almudena Avendaño Céspedes, RN, PhD +34967597684 aavendanoc@sescam.jccm.es |
Principal Investigator: | Pedro Abizanda Soler, MD,PhD | Head Geriatrics Department |
Responsible Party: | Pedro Abizanda, Prof., Complejo Hospitalario Universitario de Albacete |
ClinicalTrials.gov Identifier: | NCT04362943 |
Other Study ID Numbers: |
PAS-BAR-2020-04 |
First Posted: | April 27, 2020 Key Record Dates |
Last Update Posted: | April 27, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | At data Journal publication |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COVID-19 Older adults Hospitalization Baricitinib |
Anakinra Effectiveness Security Mortality |
Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents |