NCT04362943

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

April 22, 2020

Last Update Submit

July 27, 2021

Conditions

COVID-19

Keywords

COVID-19Older adultsHospitalizationBaricitinibAnakinraEffectivenessSecurityMortality

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality for all causes

    1 month

Secondary Outcomes (7)

  • X-ray changes

    1 month

  • Disability changes

    1 month

  • Ambulation changes

    1 month

  • lymphocyte count changes

    1 month

  • C-Reactive Protein changes

    1 month

  • +2 more secondary outcomes

Study Arms (3)

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

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

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

Interventions

Baricitinib or AnakinraDRUG

Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.

AnakinraBaricitinibComplete sample

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

baricitinibInterleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Pedro Abizanda Soler, MD,PhD

    Head Geriatrics Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 27, 2020

Study Start

April 20, 2020

Primary Completion

April 15, 2021

Study Completion

April 15, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
At data Journal publication

Locations

ES(1)