NCT04518735

Brief Summary

CORONA is a retrospective, observational, one center study to investigate the clinical evolution (in terms of survival and thromboembolic complications) of patients on chronic treatment with anticoagulants or antiplatelet agents who are admitted to the hospital for COVID-19 compared with patients who do not receive anticoagulants or antiplatelet agents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,707

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 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 18, 2020

Last Update Submit

August 18, 2020

Conditions

Keywords

Covid19Oral anticoagulantVKADOACAntiplatelet therapyHeparinLow molecular-weight heparin

Outcome Measures

Primary Outcomes (2)

  • Mortality

    From hospital admission to day 28

  • Transfer to the Intensive Care Unit (ICU)

    From hospital admission to day 28

Secondary Outcomes (2)

  • Thromboembolic complications

    From hospital admission to day 28

  • Major bleeding complications

    From hospital admission to day 28

Study Arms (3)

Patients on previous oral anticoagulant treatment

Patients receiving chronic anticoagulation with vitamin K antagonists (VKA, warfarin or acenocumarol) or with DOACs (dabigatran, rivaroxaban, apixaban or edoxaban) for any indication

Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19

Patients on previous antiplatelet therapy

Patients receiving chronic antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, dipyridamol) for any indication

Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19

Patients without antithrombotic therapy

Patients receiving nor chronic oral anticoagulation neither chronic antiplatelet therapy

Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19

Interventions

Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy

Patients on previous antiplatelet therapyPatients on previous oral anticoagulant treatmentPatients without antithrombotic therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of any age and sex, suffering from Covid19 needing hospital admission more than 1 day for treatment and/or supportive care

You may qualify if:

  • Patient admitted for COVID-19 at the Hospital de la Santa Creu i Sant Pau,
  • Positive COVID-19 polymerase chain reaction test
  • Length of stay more than 24 hours

You may not qualify if:

  • No objective diagnose for COVID-19
  • Outpatient
  • Lenght of stay less than 24hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 19, 2020

Study Start

April 1, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations