COVID-19COVID-AGENCT04362943
Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults
An observational study of COVID-19, run by Complejo Hospitalario Universitario de Albacete at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Baricitinib or Anakinra
- How many people
- 576 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2020to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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).
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- COVID-19
- Being tested
- Baricitinib or Anakinra
- Keywords
- COVID-19, Older adults, Hospitalization, Baricitinib, Anakinra, Effectiveness, Security, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib or AnakinraDrug
Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Baricitinib or Anakinra | |
| Baricitinib | Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Baricitinib. Receives: Drug: Baricitinib or Anakinra | |
| Anakinra | Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Anakinra. Receives: Drug: Baricitinib or Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality for all causes
Measured: 1 month
Secondary outcomes (7)
X-ray changes
Changes from admission to discharge thorax X-rays assessed by blinded radiologists
Measured: 1 month
Disability changes
Changes from admission to discharge in Barthel index
Measured: 1 month
Ambulation changes
Changes from admission to discharge in Functional Ambulation Classification
Measured: 1 month
lymphocyte count changes
Changes from admission to discharge in lymphocyte count
Measured: 1 month
C-Reactive Protein changes
Changes from admission to discharge in C-Reactive Protein
Measured: 1 month
Ferritin changes
Changes from admission to discharge in Ferritin
Measured: 1 month
D-Dimer changes
Changes from admission to discharge in D-Dimer
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start20 Apr 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Universitario de Albacete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Abizanda, Complejo Hospitalario Universitario de Albacete
- Investigators
- Pedro Abizanda Soler, MD,PhD, Principal investigator, Head Geriatrics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362943
- Sponsor's protocol ID
- PAS-BAR-2020-04
- Acronym
- COVID-AGE
- Status last verified
- Jul 2021
- First submitted
- 22 Apr 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults
- ClinicalTrials.gov ID
- NCT04362943
- Acronym / sponsor ID
- COVID-AGE / PAS-BAR-2020-04
- Conditions
- COVID-19
- Keywords
- COVID-19, Older adults, Hospitalization, Baricitinib, Anakinra, Effectiveness, Security, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Complejo Hospitalario Universitario de AlbaceteUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Complete sample | – | Drug: Baricitinib or AnakinraAdults 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) |
| Baricitinib | – | Drug: Baricitinib or AnakinraAdults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Baricitinib. |
| Anakinra | – | Drug: Baricitinib or AnakinraAdults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Anakinra. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib or AnakinraTreatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care. | Drug | Anakinra, Baricitinib, Complete sample |
Primary outcome
Mortality
Time frame: 1 month
Mortality for all causes
7 secondary outcomes
X-ray changes
Time frame: 1 month
Disability changes
Time frame: 1 month
Ambulation changes
Time frame: 1 month
lymphocyte count changes
Time frame: 1 month
C-Reactive Protein changes
Time frame: 1 month
Ferritin changes
Time frame: 1 month
D-Dimer changes
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Abizanda Soler, MD,PhD principal investigator
Head Geriatrics Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Complejo Hospitalario Universitario de Albacete at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.