Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| Baricitinib | Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Baricitinib. |
| |
| Anakinra | Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020 and receiving Anakinra. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib or Anakinra | Drug | Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality for all causes | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| X-ray changes | Changes from admission to discharge thorax X-rays assessed by blinded radiologists | 1 month |
| Disability changes | Changes from admission to discharge in Barthel index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pedro Abizanda Soler, MD,PhD | Head Geriatrics Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Albacete | Albacete | 02006 | Spain |
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.
At data Journal publication
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596027 | baricitinib |
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 month |
| Ambulation changes | Changes from admission to discharge in Functional Ambulation Classification | 1 month |
| lymphocyte count changes | Changes from admission to discharge in lymphocyte count | 1 month |
| C-Reactive Protein changes | Changes from admission to discharge in C-Reactive Protein | 1 month |
| Ferritin changes | Changes from admission to discharge in Ferritin | 1 month |
| D-Dimer changes | Changes from admission to discharge in D-Dimer | 1 month |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |