Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients (CORONA Study) (CORONA)

Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19

• Study Type: Observational
• Enrollment (Actual): 1707

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08025
      • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy
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; Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	From hospital admission to day 28
Transfer to the Intensive Care Unit (ICU)	From hospital admission to day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic complications	Venous thromboembolism, ischemic stroke, myocardial infarction or periferal arterial thrombosis during hospitalization for Covid19	From hospital admission to day 28
Major bleeding complications	Any bleeding complication grade 3 or 5 according BARC classification	From hospital admission to day 28

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Covid19; VKA; Heparin; Antiplatelet therapy; DOAC; Oral anticoagulant; Low molecular-weight heparin
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anticoagulants
• Other Study ID Numbers: IIBSP-COV-2020-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No